At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,343 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Placebo and Resmetirom for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 1,343 participants across 77 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Alcoholic Fatty Liver Disease
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2019
Primary CompletionJan 2023
TodayJul 2026
First PostedDec 13, 2019
Enrollment StartDec 16, 2019
Primary CompletionJan 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.6 years ago
Interventions
Placebodrug
Matching tablets
Resmetiromdrug
Tablet