Summary

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

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 Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Details

Primary and secondary endpoint population at Week 52 will be at least 900 patients, more than half fibrosis score 3 (F3), the remainder fibrosis score 2 (F2) and <10% fibrosis score F1B (F1B) based on final liver biopsy baseline fibrosis score.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  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 fibrosis suggested by the historical data.

    Meet one of the following criteria that is consistent with NASH liver fibrosis:

    1. Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9
    2. FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
    3. 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.
  4. MRI-PDFF fat fraction ≥8% obtained during the screening period
  5. 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:
    1. Steatosis (scored 0 to 3)
    2. Ballooning degeneration (scored 0 to 2)
    3. Lobular inflammation (scored 0 to 3)

You CAN'T join if...

  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. Thyroid diseases:
    1. Active hyperthyroidism.
    2. Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
    3. Patients who have had a thyroidectomy and are on replacement thyroxine doses >75 µg per day are allowed.
  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. Recent significant weight gain or loss
  6. HbA1c ≥ 9.0%.
  7. 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.
  8. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
  9. Diagnosis of hepatocellular carcinoma (HCC).

    10. MELD score ≥12, as determined at Screening, unless due to therapeutic anti

    coagulation.

    11. Hepatic decompensation 12. Chronic liver diseases other than NASH 13. Active autoimmune disease 14. Serum ALT > 250 U/L. 15. Active, serious medical disease with a likely life expectancy < 2 years. 16. Participation in an investigational new drug trial in the 60 days or 5 half-lives,

    whichever is longer.

    17. 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.

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Madrigal Pharmaceuticals, Inc.
ID
NCT03900429
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1759 people participating
Last Updated