Resmetirom for Non-alcoholic Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
+54 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Madrigal Pharmaceuticals, Inc.
Disqualifiers: Alcohol use, Carcinomas, Chronic liver diseases, Autoimmune disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial is studying the safety and tolerability of Resmetirom, a pill taken regularly. It involves patients who are already using this medication. Resmetirom helps manage certain health conditions by targeting specific parts of the body and has shown to reduce liver fat in patients with non-alcoholic steatohepatitis (NASH) in previous studies.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
How is the drug Resmetirom unique for treating non-alcoholic fatty liver disease?
Resmetirom is unique because it is an orally administered drug that specifically targets the liver and works by activating thyroid hormone receptor-β, which helps increase fat metabolism in the liver and reduce liver fat and inflammation. This mechanism is different from other treatments, as there are currently no approved drugs specifically for non-alcoholic steatohepatitis (NASH).12345
Research Team
RT
Rebecca Taub, MD
Principal Investigator
Madrigal Pharmaceuticals, Inc.
Eligibility Criteria
This trial is for patients with a specific liver condition called Non-alcoholic Fatty Liver Disease (NAFLD) who have already completed the MAESTRO-NAFLD-1 study. They must have certain levels of liver scarring and inflammation but cannot have severe liver conditions like cancer, significant alcohol use in the past year, autoimmune diseases, or other health issues that could affect their participation.Inclusion Criteria
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 with F2 or F3 NAS = 3, ballooning 0 with F2 or F3 NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
NAS = 3, ballooning 0 with F2 or F3
NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
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Exclusion Criteria
I have a long-term liver condition.
You have an ongoing autoimmune disease (a condition where the body's immune system attacks its own cells).
You have any other medical condition that could make it difficult for you to follow the study requirements or affect your health during the study.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Double-blind Treatment
Participants receive double-blind resmetirom 80 mg or 100 mg daily for the first 12 weeks
12 weeks
Open-label Treatment
Participants receive open-label resmetirom 100 mg daily for weeks 12-52
40 weeks
Open-label Extension
Participants, including those with NASH cirrhosis, may receive open-label resmetirom for an additional 52 to 104 weeks
52-104 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Resmetirom (Thyroid Hormone Receptor Agonist)
Trial OverviewThe trial is testing Resmetirom taken orally once daily for 52 weeks to see how safe it is and what its effects are on biomarkers in patients with NAFLD. It's an open-label extension which means everyone gets the active drug and knows what they're taking.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
For patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for an additional 52 weeks (ie, 52 weeks in MGL-3196-14 and 104 weeks in MGL-3196-18).
Group II: Open-Label 80 mgExperimental Treatment1 Intervention
For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for 104 weeks
Group III: Open-Label 40 mgExperimental Treatment1 Intervention
For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for 104 weeks
Group IV: Open Label 100 mgExperimental Treatment1 Intervention
For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
Group V: Double-blind 80 mg DailyExperimental Treatment1 Intervention
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Group VI: Double-blind 100 mg DailyExperimental Treatment1 Intervention
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Plano Research CenterPlano, TX
Henderson Research CenterHenderson, NV
Texas Digestive Disease Consultants - San MarcosSan Marcos, TX
Iowa Diabetes ResearchWest Des Moines, IA
More Trial Locations
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Who Is Running the Clinical Trial?
Madrigal Pharmaceuticals, Inc.
Lead Sponsor
Trials
16
Patients Recruited
5,400+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.Harrison, SA., Bashir, MR., Guy, CD., et al.[2021]
In a 52-week phase 3 trial involving 1,143 adults with presumed NASH, resmetirom was found to be safe and well tolerated, with treatment-emergent adverse events occurring in similar rates compared to placebo.
Resmetirom significantly reduced hepatic fat, LDL-C, apoB, and triglycerides, indicating its potential efficacy in treating nonalcoholic steatohepatitis and supporting further clinical development.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial.Harrison, SA., Taub, R., Neff, GW., et al.[2023]
In a Phase 2 trial, resmetirom significantly reduced liver fat and resolved non-alcoholic steatohepatitis (NASH) without worsening fibrosis, indicating its potential efficacy as a treatment for this condition.
The ongoing Phase 3 MAESTRO clinical program aims to further evaluate resmetirom's safety and effectiveness in up to 2000 adults with NASH, using liver biopsies and non-invasive tests to assess outcomes over a 54-week period.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis.Harrison, SA., Ratziu, V., Anstee, QM., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis.Javanbakht, M., Fishman, J., Moloney, E., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH.Harrison, SA., Bashir, M., Moussa, SE., et al.[2023]
References
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. [2021]
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. [2023]
Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. [2023]
Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis. [2023]
Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. [2023]