Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Keywords

NASH - Nonalcoholic Steatohepatitis, Fatty Liver, Non-alcoholic Fatty Liver Disease, MGL-3196

Eligibility

For people ages 18 years and up

Prescreening Criteria:

  • At least 3 metabolic risk factors
  • No history of significant alcohol consumption
  • Meet AST and FibroScan requirements OR have a historic liver biopsy < 2 years old demonstrating Fibrosis stage 1B, 2 or 3 with NASH [AST > 17 IU (females) or > 20 IU (males)]

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. Female patients of child-bearing potential who agree to use study-required contraceptive measures and have a negative pregnancy test
  4. Males must agree to use one of the study-required contraceptive measures or be sterile.

5 Suspected or confirmed diagnosis of NASH suggested by historical data must meet one of the following:

  1. Biochemical test for fibrosis OR
  2. FibroScan test OR c Historical liver biopsy obtained < 2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH 6. MRI-PDFF fat fraction ≥ 8% 7. 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, 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:
  3. Steatosis (scored 0 to 3) b. Ballooning degeneration (scored 0 to 2) c. Lobular inflammation (scored 0 to 3) 8. Estimated GFR ≥45

Key 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. Active hyperthyroidism, untreated clinical hypothyroidism, or have had a thyroidectomy and are on replacement thyroxine
  4. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
  5. Weight gain or loss ≥ 5% total body weight within 12 weeks prior to randomization
  6. HbA1c ≥ 9.0%.
  7. Glucagon-like peptide 1 [GLP-1] agonist therapy
  8. Use of high dose Vitamin E (> 400 IU/day) unless stable for ≥24 weeks prior to screening biopsy.
  9. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
  10. . Diagnosis of hepatocellular carcinoma (HCC).
  11. . MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
  12. . Hepatic decompensation or impairment as defined in protocol
  13. . Chronic liver diseases other than NASH
  14. . Active autoimmune disease
  15. . Serum ALT > 250 U/L.
  16. . Statins and/or other lipid-lowering therapies unless dose is stable for ≥30 days prior to randomization
  17. . Fenofibrate unless dose is stable for at least 6 weeks prior to randomization

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Alliance Clinical Research accepting new patients
    Poway California 92064 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Madrigal Pharmaceuticals, Inc.
ID
NCT03900429
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 2000 study participants
Last Updated