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NCT03900429 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A Phase 3 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Madrigal Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,759
- Enrollment target
- 20
- Study locations
NCT03900429 is a Phase 3 study of NASH - Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Madrigal Pharmaceuticals. The registered enrollment target is 1,759 participants, above the 204-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (762% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT03900429, a Phase 3 study of NASH - Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Madrigal Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,759 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,759 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 204-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (762% higher). The listed sponsor is Madrigal Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
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.
NCT03900429 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Colorado.
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.
What interventions are being tested in trial NCT03900429?
The interventions under investigation include: Placebo (DRUG), Liver Biopsy (PROCEDURE), MGL-3196 (DRUG).
Who is sponsoring clinical trial NCT03900429?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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