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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04951219 | A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) | PHASE3 | ACTIVE NOT_RECRUITING | 810 | — | — | Jul 9, 2021 | Apr 1, 2027 | May 27, 2026 | 76 | United States, Puerto Rico |
| NCT04197479 | A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients | PHASE3 | COMPLETED | 1,343 | — | — | Dec 16, 2019 | Jan 6, 2023 | Sep 5, 2023 | 77 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| Double-blind 80 mg Daily | EXPERIMENTAL | For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52 |
| Double-blind 100 mg Daily | EXPERIMENTAL | For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52 |
| Open-label | EXPERIMENTAL | For patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for up to an additional 66 months (ie, 52 weeks in MGL-3196-14 and up to 66 months in MGL-3196-18). |
| Open-Label 80 mg | EXPERIMENTAL | For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for up to 66 months. |
| Open Label 100 mg | EXPERIMENTAL | For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks |
| Open-Label 40 mg | EXPERIMENTAL | For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for up to 66 months. |
| Open label: resmetirom | EXPERIMENTAL | 100 mg daily |
| Double blinded: matching placebo | PLACEBO_COMPARATOR | Placebo daily |
| Double blinded: resmetirom 80 mg | EXPERIMENTAL | 80 mg daily |
| Double blinded: resmetirom 100 mg | EXPERIMENTAL | 100 mg daily |
| Name | Type | Description |
|---|---|---|
| Resmetirom | DRUG | Tablet |
| Placebo | DRUG | Matching tablets |
Inclusion Criteria: * For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent. * For patients who screen failed MAES...