Kansas City Research Institute | Kansas City, MO
Status and phase
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About
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
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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:
Exclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
1,759 participants in 3 patient groups, including a placebo group
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Central trial contact
Kimberly Dorney, RN, MSN
Data sourced from clinicaltrials.gov
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