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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05424003 | Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant | PHASE2 | RECRUITING | 50 | — | — | Feb 22, 2024 | Aug 1, 2026 | Jun 4, 2026 | 1 | United States |
Weight measured in kilograms
| Arm | Type | Description |
|---|---|---|
| Semaglutide | EXPERIMENTAL | Semaglutide administered subcutaneously (under the skin) once weekly. There will be a 20 week lead in period of dose escalation before reaching the target dose of 2.4mg weekly. Semaglutide will then be administered at the maximum tolerated dose for 52 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously (under the skin) once weekly. |
| Name | Type | Description |
|---|---|---|
| Semaglutide Pen Injector | DRUG | Starting dose of 0.24 mg injected weekly and increased every 4 weeks to a potential maximum dose of 2.4 mg weekly at 20 weeks followed by 52 weeks of weekly injections at the maximum tolerable dose |
| Placebo | DRUG | Placebo solution injected weekly for 72 weeks |
Inclusion Criteria: * Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.) * Liver transplant surgery within 8-24 weeks prior to randomization * Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6...