Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
NAFLD, NASH, Hyperlipidemia, Resmetirom, Thyroid hormone receptor beta, Hepatic, Fibrosis, NASH resolution, Thyroid hormone receptor agonist, Cardiovascular, Dyslipidemia, Fatty liver disease, Nonalcoholic steatohepatitis
Brief summary
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
Interventions
DRUGResmetirom
Tablet
Sponsors
Madrigal Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Select patients will be randomized in 1:1 manner to a double-blind, 12-week lead-in treatment period. Only investigators, patients, and the Sponsor will be blinded to treatment assignment during the double-blind treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent. * For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results: * NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3 * NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH) * Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD \<12, albumin ≥3.2, and bilirubin \<2 * For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score \<8) NASH cirrhosis (including minimal decompensation) and MELD \<15 unless MELD \>=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE .
Exclusion criteria
* A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1. * Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study. * Chronic liver diseases * Has an active autoimmune disease * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of once daily, oral administration of resmetirom on the incidence of adverse events. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline | 16 weeks |
| Percent change in LDL-C from baseline | 28 weeks |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORTom Hare, MD
Madrigal Pharmaceuticals, Inc.
Outcome results
None listed