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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 is a Phase 3 study that has completed, run by Madrigal Pharmaceuticals. The registered enrollment target is 1,343 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04197479
The ClinicalTrials.gov registry entry for NCT04197479 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Madrigal Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04197479 reports 0 study locations.
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.
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