GWP42003
100 mg capsules, PO, BD, 91 days
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This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-10-18
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
In this study there was a 1-5 week baseline period followed by a 13 week treatment period, and a one week follow-up. Eligible subjects entered the study at a screening visit (Visit 1) before returning for randomisation (Visit 2, Day 1). At the discretion of the investigator (based on individual subjects), Visit 1 could be split into two separate visits (Visits 1A and B) to allow a 21-day washout period of prohibited medications prior to blood sampling for eligibility. Further outpatient study visits (for assessment purposes) took place at the study site at the end of Week 4 of treatment (Visit 3, Day 29), and at the overall end of treatment at Week 13 (Visit 5, Day 92). A telephone assessment was also performed at Day 57 (Visit 4) and at Week 14 (Visit 6, Day 99) for safety follow-up purposes. During the 13 week randomised treatment phase, subjects received blinded, oral doses of their allocated randomised treatment twice daily. Treatment was self-administered on an outpatient basis, once in the morning and once in the evening for 13 weeks. Subjects were instructed to time study medication to 30 minutes before breakfast and evening meals. Physical and metabolic parameters were assessed before, during and after treatment to evaluate clinical response. Diabetic and dyslipidaemic medication usage (where applicable), and appetite 0-10 NRS data were collected daily during the treatment period, using the study diary.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
100 mg capsules, PO, BD, 91 days
Cannabidiol · CBD5 mg capsules, PO, BD, 91 days
Cannabidiol · CBD5 mg capsules, PO, BD, 91 days
delta-9-tetrahydrocannabivarin · THCV0 mg capsules, QDS, PO, 91 days
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 0.00 | 0.09 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.04 | 0.07 |
| GWP42003 and Placebo | 13 | -0.04 | 0.14 |
| GWP42004 and Placebo | 12 | 0.00 | 0.14 |
| Placebo | 13 | 0.02 | 0.09 |
Eligibility
primary outcomes
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
secondary outcomes
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Publications
No exact PMID-linked public article is currently readable locally.
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.04 | 0.12 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.06 | 0.08 |
| GWP42003 and Placebo | 9 | -0.11 | 0.08 |
| GWP42004 and Placebo | 12 | -0.01 | 0.16 |
| Placebo | 14 | -0.02 | 0.11 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.53 | 0.78 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.27 | 0.32 |
| GWP42003 and Placebo | 13 | -0.22 | 0.50 |
| GWP42004 and Placebo | 12 | -0.13 | 0.44 |
| Placebo | 13 | -0.09 | 0.39 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.12 | 0.83 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.23 | 0.28 |
| GWP42003 and Placebo | 9 | -0.11 | 0.52 |
| GWP42004 and Placebo | 12 | -0.11 | 0.45 |
| Placebo | 14 | -0.16 | 0.33 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 8 | -0.29 | 0.62 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.13 | 0.36 |
| GWP42003 and Placebo | 11 | -0.11 | 0.40 |
| GWP42004 and Placebo | 12 | -0.02 | 0.50 |
| Placebo | 13 | 0.07 | 0.33 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.03 | 0.49 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.16 | 0.26 |
| GWP42003 and Placebo | 9 | -0.08 | 0.43 |
| GWP42004 and Placebo | 12 | -0.08 | 0.41 |
| Placebo | 14 | -0.06 | 0.19 |
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 8 | 0.03 | 0.11 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.04 | 0.05 |
| GWP42003 and Placebo | 11 | -0.02 | 0.08 |
| GWP42004 and Placebo | 12 | 0.02 | 0.09 |
| Placebo | 13 | 0.01 | 0.06 |
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.01 | 0.11 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.00 | 0.05 |
| GWP42003 and Placebo | 9 | -0.02 | 0.08 |
| GWP42004 and Placebo | 12 | 0.03 | 0.12 |
| Placebo | 14 | 0.01 | 0.06 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.06 | 0.37 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.01 | 0.16 |
| GWP42003 and Placebo | 9 | 0.08 | 0.19 |
| GWP42004 and Placebo | 12 | -0.02 | 0.24 |
| Placebo | 14 | -0.08 | 0.31 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.47 | 0.54 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.14 | 0.28 |
| GWP42003 and Placebo | 13 | 0.09 | 0.55 |
| GWP42004 and Placebo | 12 | 0.09 | 0.66 |
| Placebo | 13 | -0.12 | 0.80 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.16 | 0.56 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.12 | 0.26 |
| GWP42003 and Placebo | 9 | 0.16 | 0.34 |
| GWP42004 and Placebo | 12 | 0.05 | 0.59 |
| Placebo | 14 | -0.03 | 0.74 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -2.86 | 8.84 |
| 20:1 GWP42003 : GWP42004 | 11 | -3.51 | 10.88 |
| GWP42003 and Placebo | 13 | -4.92 | 6.04 |
| GWP42004 and Placebo | 12 | 0.64 | 11.32 |
| Placebo | 14 | -3.41 | 6.22 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.19 | 0.84 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.18 | 0.51 |
| GWP42003 and Placebo | 13 | 0.11 | 0.53 |
| GWP42004 and Placebo | 12 | 0.08 | 0.66 |
| Placebo | 13 | 0.16 | 0.42 |
A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.01 | 0.23 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.07 | 0.15 |
| GWP42003 and Placebo | 13 | 0.08 | 0.13 |
| GWP42004 and Placebo | 12 | 0.01 | 0.14 |
| Placebo | 13 | 0.07 | 0.12 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 0.06 | 0.17 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.03 | 0.23 |
| GWP42003 and Placebo | 13 | -0.05 | 0.30 |
| GWP42004 and Placebo | 12 | -0.02 | 0.18 |
| Placebo | 13 | 0.01 | 0.15 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -0.23 | 2.02 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.44 | 2.00 |
| GWP42003 and Placebo | 13 | 0.41 | 0.82 |
| GWP42004 and Placebo | 11 | -0.76 | 1.00 |
| Placebo | 13 | 0.38 | 1.15 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 2.8 | 42.06 |
| 20:1 GWP42003 : GWP42004 | 10 | 14.5 | 29.53 |
| GWP42003 and Placebo | 13 | -2.6 | 20.41 |
| GWP42004 and Placebo | 12 | 1.1 | 11.68 |
| Placebo | 13 | 9.5 | 19.68 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 0.14 | 1.41 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.16 | 0.44 |
| GWP42003 and Placebo | 13 | 0.08 | 0.44 |
| GWP42004 and Placebo | 12 | -0.03 | 0.22 |
| Placebo | 14 | 0.31 | 0.54 |
A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 6 | -0.07 | 1.89 |
| 20:1 GWP42003 : GWP42004 | 10 | 1.09 | 3.81 |
| GWP42003 and Placebo | 12 | -0.78 | 1.51 |
| GWP42004 and Placebo | 11 | 0.22 | 1.85 |
| Placebo | 13 | 0.42 | 1.44 |
At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | 80.9 | 223.91 |
| 20:1 GWP42003 : GWP42004 | 9 | -156.6 | 358.53 |
| GWP42003 and Placebo | 12 | -193.5 | 232.17 |
| GWP42004 and Placebo | 11 | 83.5 | 427.94 |
| Placebo | 13 | -40.8 | 475.88 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 12.01 | 56.22 |
| 20:1 GWP42003 : GWP42004 | 11 | -6.06 | 104.78 |
| GWP42003 and Placebo | 13 | 13.44 | 49.03 |
| GWP42004 and Placebo | 11 | 45.62 | 183.92 |
| Placebo | 13 | 2.79 | 61.44 |
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 0.02 | 0.15 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.09 | 0.28 |
| GWP42003 and Placebo | 12 | -0.03 | 0.18 |
| GWP42004 and Placebo | 12 | 0.12 | 0.31 |
| Placebo | 14 | 0.09 | 0.25 |
Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 0.19 | 1.00 |
| 20:1 GWP42003 : GWP42004 | 11 | -0.19 | 2.54 |
| GWP42003 and Placebo | 13 | 0.35 | 1.20 |
| GWP42004 and Placebo | 11 | 0.64 | 3.15 |
| Placebo | 13 | 0.09 | 1.22 |
Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | -5.26 | 8.62 |
| 20:1 GWP42003 : GWP42004 | 11 | -1.71 | 12.62 |
| GWP42003 and Placebo | 13 | 1.71 | 26.48 |
| GWP42004 and Placebo | 11 | 6.47 | 27.00 |
| Placebo | 13 | -4.07 | 13.16 |
Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 9 | 8.13 | 23.56 |
| 20:1 GWP42003 : GWP42004 | 11 | -7.64 | 35.00 |
| GWP42003 and Placebo | 13 | -1.31 | 19.06 |
| GWP42004 and Placebo | 11 | 36.59 | 70.55 |
| Placebo | 13 | -2.41 | 19.96 |
Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -0.38 | 0.65 |
| 20:1 GWP42003 : GWP42004 | 12 | -0.02 | 0.72 |
| GWP42003 and Placebo | 13 | -0.20 | 1.16 |
| GWP42004 and Placebo | 12 | -0.21 | 1.09 |
| Placebo | 14 | -0.50 | 2.12 |
Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -0.00 | 0.06 |
| 20:1 GWP42003 : GWP42004 | 12 | -0.00 | 0.04 |
| GWP42003 and Placebo | 13 | 0.00 | 0.03 |
| GWP42004 and Placebo | 12 | -0.00 | 0.02 |
| Placebo | 14 | -0.01 | 0.02 |
Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -1.05 | 1.88 |
| 20:1 GWP42003 : GWP42004 | 12 | -0.10 | 2.07 |
| GWP42003 and Placebo | 13 | -0.46 | 3.40 |
| GWP42004 and Placebo | 12 | -0.66 | 3.09 |
| Placebo | 14 | -1.64 | 6.66 |
Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | 0.82 | 3.90 |
| 20:1 GWP42003 : GWP42004 | 12 | -0.17 | 2.59 |
| GWP42003 and Placebo | 13 | 0.31 | 4.31 |
| GWP42004 and Placebo | 12 | -0.39 | 1.48 |
| Placebo | 14 | -0.86 | 2.55 |
Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | 1.12 | 4.93 |
| 20:1 GWP42003 : GWP42004 | 12 | 0.07 | 2.54 |
| GWP42003 and Placebo | 13 | 0.38 | 3.48 |
| GWP42004 and Placebo | 12 | -0.19 | 1.30 |
| Placebo | 14 | -0.20 | 2.86 |
Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | 0.10 | 0.96 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.62 | 1.02 |
| GWP42003 and Placebo | 13 | 0.42 | 0.87 |
| GWP42004 and Placebo | 11 | -0.11 | 0.78 |
| Placebo | 12 | 0.27 | 1.97 |
Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -0.3 | 1.05 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.5 | 0.56 |
| GWP42003 and Placebo | 13 | -0.0 | 0.66 |
| GWP42004 and Placebo | 11 | 0.1 | 0.84 |
| Placebo | 12 | 0.3 | 1.39 |
Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -0.23 | 1.53 |
| 20:1 GWP42003 : GWP42004 | 11 | 1.08 | 1.42 |
| GWP42003 and Placebo | 13 | 0.37 | 1.25 |
| GWP42004 and Placebo | 11 | -0.05 | 1.52 |
| Placebo | 12 | 0.59 | 3.24 |
Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | -0.22 | 1.13 |
| 20:1 GWP42003 : GWP42004 | 4 | -0.75 | 0.87 |
| GWP42003 and Placebo | 6 | 0.02 | 0.62 |
| GWP42004 and Placebo | 6 | -0.29 | 0.75 |
| Placebo | 7 | -0.37 | 0.43 |
Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | 0.6 | 2.98 |
| 20:1 GWP42003 : GWP42004 | 4 | 0.4 | 1.35 |
| GWP42003 and Placebo | 6 | 0.2 | 1.37 |
| GWP42004 and Placebo | 6 | 0.8 | 3.17 |
| Placebo | 7 | -2.4 | 2.45 |
Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | 0.33 | 3.81 |
| 20:1 GWP42003 : GWP42004 | 4 | -0.36 | 1.52 |
| GWP42003 and Placebo | 6 | 0.18 | 1.99 |
| GWP42004 and Placebo | 6 | 0.56 | 3.87 |
| Placebo | 7 | -2.81 | 2.37 |
Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | -0.09 | 2.13 |
| 20:1 GWP42003 : GWP42004 | 4 | 0.46 | 0.56 |
| GWP42003 and Placebo | 6 | 0.40 | 1.07 |
| GWP42004 and Placebo | 6 | -0.52 | 1.29 |
| Placebo | 7 | -0.88 | 1.36 |
Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | 0.22 | 2.63 |
| 20:1 GWP42003 : GWP42004 | 4 | 1.11 | 0.78 |
| GWP42003 and Placebo | 6 | 0.01 | 1.88 |
| GWP42004 and Placebo | 6 | 1.08 | 3.26 |
| Placebo | 7 | -2.44 | 2.25 |
Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | 0.13 | 4.61 |
| 20:1 GWP42003 : GWP42004 | 4 | 1.57 | 0.46 |
| GWP42003 and Placebo | 6 | 0.40 | 2.65 |
| GWP42004 and Placebo | 6 | 0.57 | 4.34 |
| Placebo | 7 | -3.31 | 2.91 |
Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 7 | -0.02 | 0.08 |
| 20:1 GWP42003 : GWP42004 | 4 | 0.05 | 0.06 |
| GWP42003 and Placebo | 6 | -0.01 | 0.06 |
| GWP42004 and Placebo | 6 | 0.01 | 0.08 |
| Placebo | 7 | 0.04 | 0.10 |
Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | -1.12 | 19.75 |
| 20:1 GWP42003 : GWP42004 | 11 | 0.37 | 7.15 |
| GWP42003 and Placebo | 13 | -4.73 | 9.87 |
| GWP42004 and Placebo | 11 | 0.77 | 10.56 |
| Placebo | 11 | -2.95 | 12.40 |
Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 10 | -1.19 | 2.02 |
| 20:1 GWP42003 : GWP42004 | 12 | -0.84 | 1.96 |
| GWP42003 and Placebo | 13 | -0.69 | 0.99 |
| GWP42004 and Placebo | 11 | -0.36 | 2.01 |
| Placebo | 14 | -0.59 | 1.10 |
The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.
Population: All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | 7 | - |
| 20:1 GWP42003 : GWP42004 | 12 | 8 | - |
| GWP42003 and Placebo | 13 | 11 | - |
| GWP42004 and Placebo | 12 | 11 | - |
| Placebo | 14 | 13 | - |
The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.
Population: The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| 1:1 GWP42003 : GWP42004 | 11 | 0.27 | 1.27 |
| 20:1 GWP42003 : GWP42004 | 11 | 4.91 | 8.08 |
| GWP42003 and Placebo | 13 | 0.85 | 2.23 |
| GWP42004 and Placebo | 12 | 0.58 | 2.15 |
| Placebo | 13 | -0.08 | 4.17 |
| Milestone | 1:1 GWP42003 : GWP42004 | 20:1 GWP42003 : GWP42004 | GWP42003 and Placebo | GWP42004 and Placebo | Placebo |
|---|---|---|---|---|---|
| STARTED | 11 | 12 | 13 | 12 | 14 |
| COMPLETED | 11 | 10 | 12 | 10 | 13 |
| NOT COMPLETED | 0 | 2 | 1 | 2 | 1 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Myocardial ischaemia | Cardiac disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Myocardial infarction | Cardiac disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Self-injurious ideation | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Suicidal ideation | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Myocardial infarction | Cardiac disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Myocardial ischaemia | Cardiac disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Dermoid cyst | Congenital, familial and genetic disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Hyperparathyroidism primary | Endocrine disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Conjunctival haemorrhage | Eye disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Retinal haemorrhage | Eye disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Vision blurred | Eye disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Visual impairment | Eye disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Abdominal distension | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Abdominal pain | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Abdominal pain upper | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Change of bowel habit | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Diarrhoea | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 2 / 12 · Placebo: 0 / 14 |
| Flatulence | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Nausea | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Rectal haemorrhage | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Vomiting | Gastrointestinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Fatigue | General disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 1 / 14 |
| Feeling abnormal | General disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Irritability | General disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Malaise | General disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Oedema peripheral | General disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 1 / 14 |
| Vessel puncture site reaction | General disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Hepatic steatosis | Hepatobiliary disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Ear infection fungal | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Genital candidiasis | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Influenza | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 2 / 14 |
| Laryngitis | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Lower respiratory tract infection | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Nasopharyngitis | Infections and infestations | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 2 / 12 · Placebo: 0 / 14 |
| Tinea pedis | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Urinary tract infection | Infections and infestations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Foreign body | Injury, poisoning and procedural complications | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Joint sprain | Injury, poisoning and procedural complications | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Alanine aminotransferase increased | Investigations | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Blood thyroid stimulating hormone decreased | Investigations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Cardiac murmur | Investigations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Weight increased | Investigations | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Decreased appetite | Metabolism and nutrition disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 2 / 13 · GWP42004 and Placebo: 4 / 12 · Placebo: 2 / 14 |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Gout | Metabolism and nutrition disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Increased appetite | Metabolism and nutrition disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 1 / 14 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 2 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Arthritis | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Joint instability | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Joint swelling | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Muscle twitching | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 2 / 14 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Carpal tunnel syndrome | Nervous system disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Disturbance in attention | Nervous system disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Dizziness | Nervous system disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 2 / 14 |
| Headache | Nervous system disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 1 / 14 |
| Lethargy | Nervous system disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
| Abnormal dreams | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Affect lability | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Depression | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Insomnia | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Sleep disorder | Psychiatric disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Haematuria | Renal and urinary disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 2 / 12 · Placebo: 2 / 14 |
| Hypertonic bladder | Renal and urinary disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Pollakiuria | Renal and urinary disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Dry throat | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 1 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 1 / 14 |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 1 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Eczema | Skin and subcutaneous tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Rosacea | Skin and subcutaneous tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Skin odour abnormal | Skin and subcutaneous tissue disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 1 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 0 / 12 · Placebo: 0 / 14 |
| Hypertension | Vascular disorders | 1:1 GWP42003 : GWP42004: 0 / 11 · 20:1 GWP42003 : GWP42004: 0 / 12 · GWP42003 and Placebo: 0 / 13 · GWP42004 and Placebo: 1 / 12 · Placebo: 0 / 14 |
Time frame: Baseline (Day 1) and End of treatment (Day 92)
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time frame: Day 1 - Day 92
The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.
Time frame: Baseline (Day 1) and the End of Treatment (Day 92)
The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.