Non-alcoholic Steatohepatitis (NASH) Cirrhosis
Conditions
Brief summary
The primary endpoint is the effect of once-daily, oral administration of resmetirom versus matching placebo on NASH CP-A patients, as measured by the time to a confirmed adjudicated Composite Clinical Outcome event. The composite clinical outcome event is composed of liver-related or CV mortality, liver transplant, significant hepatic events including hepatic decompensation events and confirmed increase of MELD score from <12 to ≥15.
Detailed description
1. Percent change from baseline in LDL-C at Week 28 2. Percent change from Baseline to Week 52 in hepatic fat fraction by MRI-PDFF in patients with baseline MRI-PDFF >=5%.
Interventions
DRUGMatching placebo MGL-3196 100 mg film-coated tablet
Sponsors
Madrigal Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the effect of once-daily, oral administration of resmetirom versus matching placebo on NASH CP-A patients, as measured by the time to a confirmed adjudicated Composite Clinical Outcome event. The composite clinical outcome event is composed of liver-related or CV mortality, liver transplant, significant hepatic events including hepatic decompensation events and confirmed increase of MELD score from <12 to ≥15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent change from baseline in LDL-C at Week 28 2. Percent change from Baseline to Week 52 in hepatic fat fraction by MRI-PDFF in patients with baseline MRI-PDFF >=5%. | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed