Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01284634 | Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease | PHASE2 | COMPLETED | 25 | — | — | May 3, 2011 | Jul 13, 2012 | Aug 8, 2018 | 3 | United Kingdom |
Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
| Arm | Type | Description |
|---|---|---|
| GWP42003 200 milligrams (mg)/day Dose | EXPERIMENTAL | Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). |
| GWP42003 400 mg/day Dose | EXPERIMENTAL | Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). |
| GWP42003 800 mg/day Dose | EXPERIMENTAL | Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). |
| Placebo | EXPERIMENTAL | Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. |
| Name | Type | Description |
|---|---|---|
| GWP42003 200 mg/day Dose | DRUG | GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). |
| GWP42003 400 mg/day Dose | DRUG | GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). |
| GWP42003 800 mg/day Dose | DRUG | GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). |
| Placebo | DRUG | Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14). |
Inclusion Criteria: * Participant gave informed consent for participation in the study. * Participant was aged 18 years or above. * Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS scanning or a biopsy within two months prior to screening, or willing to undergo an...