Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GWP42003/day Dose · 1 trial · 1 indication
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...
GWP42003 is an investigational small molecule being studied for dyslipidemias, schizophrenia, fatty liver, and ulcerative colitis. It has completed Phase 2 trials in these indications, including as adjunctive therapy in schizophrenia and related psychotic disorders.
GWP42003 is being developed by Jazz Pharmaceuticals plc, traded on NASDAQ under the ticker JAZZ. The company has conducted Phase 2 clinical trials of this investigational drug across multiple indications.
GWP42003 is in Phase 2 clinical development. All four completed trials were Phase 2 studies, and the drug remains investigational, not yet approved by regulatory authorities.
GWP42003 has completed four Phase 2 trials: NCT01217112 in dyslipidemias and type 2 diabetes, NCT01284634 in fatty liver, NCT01562314 in ulcerative colitis, and NCT02006628 in schizophrenia. These trials were conducted in the United Kingdom, Poland, and Romania.
GWP42003 is distinct from GWP42004. One trial, NCT01217112, studied GWP42003 and GWP42004 together and alone in type 2 diabetes, indicating they are separate investigational compounds being evaluated individually and in combination.