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Resmetirom · 5 trials · 5 indications
Any event of all-cause mortality, liver transplant, ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage, and confirmed increase of MELD score from \<12 to \>/= 15 due to liver disease
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
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| Arm | Type | Description |
|---|---|---|
| Resmetirom | ACTIVE_COMPARATOR | 80 mg daily |
| Placebo | PLACEBO_COMPARATOR | matching placebo daily |
| 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 |
| Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1 | ACTIVE_COMPARATOR | - |
| Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2 | ACTIVE_COMPARATOR | - |
| Arm 3: Placebo - Cohort 1 | PLACEBO_COMPARATOR | - |
| Arm 4: Placebo - Cohort 2 | PLACEBO_COMPARATOR | - |
| Severe renal impairment | EXPERIMENTAL | - |
| Normal Healthy Match | EXPERIMENTAL | Matched to severe renal impairment |
| Name | Type | Description |
|---|---|---|
| Resmetirom | DRUG | Randomized 80 mg |
| Placebo | DRUG | randomized matching placebo |
| 100 mg Resmetirom Tablet | DRUG | Once daily oral dose for 6 days |
Inclusion Criteria: * A clinical diagnosis of NASH cirrhosis * At least 3 metabolic risk factors * Historical liver biopsy read as consistent with NASH cirrhosis. * Historical biopsy consistent with NASH with significant fibrosis, now with progression to cirrhosis. Or, no historical biopsy, with a ...