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NOT YET RECRUITING
NCT07830758
PHASE1

Resmetirom in Patients With MASH and HFpEF

Sponsor: Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1b, Multi-Center, Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Hepatic Pharmacodynamics of Resmetirom in Patients With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Heart Failure With Preserved Ejection Fraction (HFpEF)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-09

Completion Date

2027-12

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Resmetirom

Resmetirom (80 mg or 100 mg orally once daily based on body weight)

DRUG

Placebo

Matching placebo orally once daily