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NCT04197479 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A Phase 3 study, sponsored by Madrigal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,343
- Enrollment target
NCT04197479: Completed Phase 3 study, sponsored by Madrigal Pharmaceuticals.
NCT04197479 is a Phase 3 study that has completed, run by Madrigal Pharmaceuticals. The registered enrollment target is 1,343 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04197479, a Phase 3 study, has completed, sponsored by Madrigal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,343 participants
- Enrollment target
Study 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).
Primary Outcome
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
Interventions
- DRUG Placebo
- DRUG Resmetirom
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,343 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 3 |
What the finished NCT04197479 record still lists
NCT04197479 is an interventional study that assigns participants to a tested intervention. Its 1,343 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04197479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04197479 about?
NCT04197479 is a clinical study titled "A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients". 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...
What is the current status of trial NCT04197479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,343 participants. The study started on 2019-12-16. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT04197479?
The interventions under investigation include: Placebo (DRUG), Resmetirom (DRUG).
Who is sponsoring clinical trial NCT04197479?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04197479's enrollment target sits among peer trials
1,343 182nd of 2000 higher than 1,819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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