Resmetirom in adults with fatty liver disease MASH and heart failure
Tests resmetirom against placebo in adults with MASH and HFpEF.
Plain-language title generated from the registry record
Registry title: Resmetirom in Patients With MASH and HFpEF
Key facts
- Where
- Fort Myers, Oxnard, Peoria, Riverview, and University Park, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- Covenant Metabolic SpecialistFort Myers, United StatesTaking people
- FOMAT - Clinicas Mi SaludOxnard, United StatesTaking people
- Arizona Clinical TrialsPeoria, United StatesTaking people
- Covenant Metabolic SpecialistRiverview, United StatesTaking people
- Covenant Metabolic SpecialistUniversity Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Madrigal Pharmaceuticals, Inc.
- Trial code
- NCT07830758
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Must be willing to participate in the study and provide written informed consent; Male and female adults ≥18 years of age; Suspected or confirmed diagnosis of fibrotic MASH suggested by the historical data and meets at least 1 criteria for fibrotic MASH; Confirmed diagnosis of HFpEF; Structural and/or functional heart disease based on echocardiographic evaluation; eGFR ≥45 mL/min/1.73 m2; 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.
Exclusion: 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; History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study; Weight gain or loss >5% total body weight within 12 weeks prior to randomization; Presence of sustained atrial fibrillation at time of Screening or history of paroxysmal atrial fibrillation episodes for the last 3 months prior to Screening; Patients with cirrhosis and other etiologies of chronic liver disease; Thyroid disease:; Active hyperthyroidism; Untreated clinical hypothyroidism defined by TSH >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms; MELD score ≥12, as determined at Screening, due to liver disease; Hepatic decompensation or impairment; Has an active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease, or autoimmune hepatitis, requiring systemic treatment within the past 12 weeks or a documented history of clinically severe autoimmune disease, including autoimmune liver disease, or a syndrome that requires systemic steroids or immunosuppressive agents; History of biliary diversion; Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure >170 mmHg or a diastolic blood pressure >100 mmHg at Screening; HbA1c >9.0%; Serum ALT >250 U/L; Platelet count <140,000/mm3. Patients with platelets <140,000 and ≥120,000/mm3 are eligible if FIB-4 score <3.5; Diagnosis of HCC; Confirmed QTcF >450 msec for males and >470 msec for females at the Screening ECG assessment.