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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Madrigal Pharmaceuticals, Inc.

Criteria

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.