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A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT03900429 · View on ClinicalTrials.gov ↗
Study Summary
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Conditions Studied
Interventions
- DRUG Placebo
- PROCEDURE Liver Biopsy
- DRUG MGL-3196
Study Locations (20)
California
- Fresno Clinical Research Center — Fresno
- National Research Institute - Huntington Park — Huntington Park
- University of California San Diego — La Jolla
- Cedars-Sinai Medical Center — Los Angeles
- National Research Institute - Los Angeles — Los Angeles
- Ruane Clinical Research — Los Angeles
- Stanford University School of Medicine — Palo Alto
- National Research Institute - Panorama City — Panorama City
- Alliance Clinical Research — Poway
- San Fernando Valley Health Institute — Van Nuys
Arizona
- East Valley Family Physicians — Chandler
- The Institute for Liver Health - Chandler — Chandler
- The Institute for Liver Health - Glendale — Glendale
- Desert Clinical Research — Mesa
- Adobe Gastroenterology — Tucson
- The Institute for Liver Health - Tucson — Tucson
Colorado
- Colorado Springs Family Practice — Colorado Springs
- South Denver Gastroenterology - Swedish Medical Center Office — Englewood
Alabama
- University of Alabama at Birmingham — Birmingham
Arkansas
- Arkansas Gastroenterology — North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,759 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03900429
The ClinicalTrials.gov registry entry for NCT03900429 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,759 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Madrigal Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03900429 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03900429 about?
NCT03900429 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis". A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
What is the current status of trial NCT03900429?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,759 participants. The study started on 2019-03-28. Estimated completion is 2028-01.
What conditions does trial NCT03900429 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03900429?
The interventions under investigation include: Placebo (DRUG), Liver Biopsy (PROCEDURE), MGL-3196 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03900429?
This trial is sponsored by Madrigal Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03900429 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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