RecruitingMASH - Metabolic Dysfunction-Associated SteatohepatitisHeart Failure With Preserved Ejection Fraction (HFPEF)
Resmetirom in Patients With MASH and HFpEF
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Madrigal Pharmaceuticals, Inc.
You may qualify if…
- ✓ 1. Must be willing to participate in the study and provide written informed consent.
- ✓ 2. Male and female adults ≥18 years of age.
- ✓ 3. Suspected or confirmed diagnosis of fibrotic MASH suggested by the historical data and meets at least 1 criteria for fibrotic MASH
- ✓ 4. Confirmed diagnosis of HFpEF
- ✓ 5. Structural and/or functional heart disease based on echocardiographic evaluation.
- ✓ 6. eGFR ≥45 mL/min/1.73 m2
- ✓ 7. Female patients of reproductive potential are eligible if they have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use 1 highly effective birth control method during the study and for at least 30 days after study drug administration. Highly effective birth control methods include hormonal and non-hormonal intrauterine device, combination estrogen-progesterone hormonal contraception (oral, transdermal, or vaginal), tubal ligation, a vasectomized or sterile male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from Screening, throughout the study and for at least 30 days after study drug administration.
You may not qualify if…
- ✕ 1. Patients with cirrhosis and other etiologies of chronic liver disease
- ✕ 2. PEth value of ≥20 ng/mL measured at Screening OR history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
- ✕ 3. Thyroid disease:
- ✕ 1. Active hyperthyroidism
- ✕ 2. Untreated clinical hypothyroidism defined by TSH \>7 IU/L with symptoms of hypothyroidism or \>10 IU/L without symptoms
- ✕ 4. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
- ✕ 5. Weight gain or loss \>5% total body weight within 12 weeks prior to randomization
- ✕ 6. HbA1c \>9.0%
Where it's recruiting
Source: ClinicalTrials.gov · NCT07830758 · last updated 2026-10-16