Trials / Completed
CompletedNCT04197479
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,343 (actual)
- Sponsor
- Madrigal Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo. At least 100 patients will be enrolled in a 100 mg open-label arm and will include a special safety population (eg, patients with compensated NASH cirrhosis).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching tablets |
| DRUG | Resmetirom | Tablet |
Timeline
- Start date
- 2019-12-16
- Primary completion
- 2023-01-06
- Completion
- 2023-01-06
- First posted
- 2019-12-13
- Last updated
- 2023-09-05
Locations
77 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04197479. Inclusion in this directory is not an endorsement.