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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1759

Last updated 2026-05-13

No results posted yet for this 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

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

MGL-3196

Tablet

DRUG

Placebo

Matching Tablets

PROCEDURE

Liver Biopsy

A procedure in which a needle is inserted into the liver to collect a tissue sample

Sponsors & Collaborators

  • Madrigal Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Rebecca Taub, MD · Madrigal Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • Puerto Rico
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900429 on ClinicalTrials.gov