Resmetirom for Fatty Liver Disease and Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). Participants are randomized 2:1 to resmetirom or placebo for 24 weeks.
Who Is on the Research Team?
Uli Frevert, MD
Principal Investigator
Madrigal Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for adults 18 and older with both fatty liver disease (MASH) showing signs of fibrosis and a type of heart failure called HFpEF. Participants need to have certain kidney function, be willing to consent, and women must use effective birth control if they could become pregnant.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Resmetirom
Trial Overview
The study tests resmetirom versus placebo in people with MASH and HFpEF. Participants are randomly assigned in a double-blind way (neither doctors nor patients know the group) for 24 weeks to see how safe the drug is and its effects on the liver.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive resmetirom orally once daily for 24 weeks. Resmetirom dose will be based on actual body weight: 80 mg once daily for participants weighing \<100 kg and 100 mg once daily for participants weighing ≥100 kg. Dose reduction by 20 mg will be implemented for concomitant use of a moderate CYP2C8 inhibitor, as specified in the protocol
Participants will receive matching placebo orally once daily for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madrigal Pharmaceuticals, Inc.
Lead Sponsor
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