Purpose

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 on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Must be willing to participate in the study and provide written informed consent. 2. Male and female adults ≥ 18 years of age. 3. Suspected or confirmed diagnosis of NASH 1. Metabolic risk factors and AST > 20 U/L 2. Criteria consistent with liver fibrosis as defined as one of the following: - Biochemical test for fibrosis OR - Fibroscan test OR - Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3 4. MRI-PDFF with increased fat fraction 5. Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24 weeks before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A, 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: 1. Steatosis (scored 0 to 3) 2. Ballooning degeneration (scored 0 to 2) 3. Lobular inflammation (scored 0 to 3)

Exclusion Criteria

  1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening. 2. Regular use of drugs historically associated with NAFLD 3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study. 4. Recent significant weight gain or loss 5. HbA1c ≥ 9.0%. 6. 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. 7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis. 8. Diagnosis of hepatocellular carcinoma (HCC). 9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation. 10. Hepatic decompensation 11. Chronic liver diseases other than NASH 12. Active autoimmune disease 13. Serum ALT > 250 U/L. 14. Active, serious medical disease with a likely life expectancy < 2 years. 15. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer. 16. 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Matching Placebo
Placebo Daily
  • Drug: Placebo
    Matching Tablets
Active Comparator
80 mg MGL-3196
80 mg daily
  • Drug: MGL-3196
    Tablet
    Other names:
    • Resmetirom
Active Comparator
100 mg MGL-3196
100 mg daily
  • Drug: MGL-3196
    Tablet
    Other names:
    • Resmetirom

Recruiting Locations

University of Kansas Medical Center Research Institute
Fairway, Kansas 66205

More Details

Status
Recruiting
Sponsor
Madrigal Pharmaceuticals, Inc.

Study Contact

Kimberly Dorney, RN, MSN
267-520-0252
info@madrigalpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.