A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT03900429

Run by

Madrigal Pharmaceuticals, Inc.

People needed

1759

Starts

2019-03-28

Expected to finish

2028-01-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be willing to participate in the study and provide written informed consent.
• Male and female adults ≥ 18 years of age.
• Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NASH liver fibrosis:
• Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9
• FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
• Historical liver biopsy obtained <2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH based on existing pathology review, with no significant change in body weight >5% or medication that might affect NAS or fibrosis stage.
• MRI-PDFF fat fraction ≥8% obtained during the screening period
• Biopsy-proven NASH (baseline liver biopsy) based on a liver biopsy obtained ≤6 months before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A/1C, 1B, 2, or 3 on liver biopsy and NAS of ≥4 with a score of at least 1 in each of the following NAS components:
• Steatosis (scored 0 to 3)
• Ballooning degeneration (scored 0 to 2)
• Lobular inflammation (scored 0 to 3)

You may not qualify if…

• History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
• Regular use of drugs historically associated with NAFLD
• Thyroid diseases:
• Active hyperthyroidism.
• Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
• Patients who have had a thyroidectomy and are on replacement thyroxine doses >75 µg per day are allowed.
• History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
• Recent significant weight gain or loss
• HbA1c ≥ 9.0%.
• Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
• Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
• Diagnosis of hepatocellular carcinoma (HCC).
• MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
• Hepatic decompensation
• Chronic liver diseases other than NASH
• Active autoimmune disease
• Serum ALT > 250 U/L.
• Active, serious medical disease with a likely life expectancy < 2 years.
• Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
• Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.

Where it is running

• East Valley Family Physicians — Chandler, Arizona, United States
• The Institute for Liver Health - Chandler — Chandler, Arizona, United States
• The Institute for Liver Health - Glendale — Glendale, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Adobe Gastroenterology — Tucson, Arizona, United States
• The Institute for Liver Health - Tucson — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Fresno Clinical Research Center — Fresno, California, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• University of California San Diego — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• National Research Institute - Los Angeles — Los Angeles, California, United States
• Ruane Clinical Research — Los Angeles, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• National Research Institute - Panorama City — Panorama City, California, United States
• Alliance Clinical Research — Poway, California, United States
• San Fernando Valley Health Institute — Van Nuys, California, United States
• Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• South Denver Gastroenterology - Swedish Medical Center Office — Englewood, Colorado, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Covenant Metabolic Specialists - Fort Myers — Fort Myers, Florida, United States
• University of Florida Hepatology Research at CTRB — Gainesville, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.