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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03900429 | A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis | PHASE3 | ACTIVE NOT_RECRUITING | 1,759 | — | — | Mar 28, 2019 | Jan 1, 2028 | Jun 1, 2026 | 247 | United States, Australia +14 |
1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR 2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
The Composite Clinical Outcome is composed of all-cause mortality, liver transplant, and significant hepatic events (including hepatic decompensation events \[ascites, encephalopathy, or gastroesophageal variceal hemorrhage\], histological progression to cirrhosis, and a confirmed increase of MELD score from \<12 to ≥15).
| Arm | Type | Description |
|---|---|---|
| Matching Placebo | PLACEBO_COMPARATOR | Placebo Daily |
| 80 mg MGL-3196 | ACTIVE_COMPARATOR | 80 mg daily |
| 100 mg MGL-3196 | ACTIVE_COMPARATOR | 100 mg daily |
| Name | Type | Description |
|---|---|---|
| MGL-3196 | DRUG | Tablet |
| Placebo | DRUG | Matching Tablets |
| Liver Biopsy | PROCEDURE | A procedure in which a needle is inserted into the liver to collect a tissue sample |
Inclusion Criteria: 1. Must be willing to participate in the study and provide written informed consent. 2. Male and female adults ≥ 18 years of age. 3. Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NAS...