Resmetirom for MASH with HFpEF in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1b, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and hepatic pharmacodynamic effects of resmetirom in adults with fibrotic MASH and HFpEF. Participants are randomized 2:1 to receive resmetirom or placebo for 24 weeks. The trial includes adults with confirmed HFpEF, suspected or confirmed fibrotic MASH, and adequate kidney function, with plans for close safety monitoring. Primary endpoints focus on safety and tolerability, with secondary assessments related to liver pharmacodynamics. Locations include sites in Arizona, California, and Florida, sponsored by Madrigal Pharmaceuticals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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%
7. Diagnosis of HCC
8. MELD score ≥12, as determined at Screening, due to liver disease
9. Hepatic decompensation or impairment.
10. 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
11. Serum ALT \>250 U/L
12. Platelet count \<140,000/mm3. Patients with platelets \<140,000 and ≥120,000/mm3 are eligible if FIB-4 score \<3.5.
13. History of biliary diversion
14. Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \>170 mmHg or a diastolic blood pressure \>100 mmHg at Screening
15. Confirmed QTcF \>450 msec for males and \>470 msec for females at the Screening ECG assessment;
16. Presence of sustained atrial fibrillation at time of Screening or history of paroxysmal atrial fibrillation episodes for the last 3 months prior to Screening

Where it's running

• Arizona Clinical Trials
  Peoria, Arizona, United States Recruiting
• FOMAT - Clinicas Mi Salud
  Oxnard, California, United States Recruiting
• Covenant Metabolic Specialist
  Fort Myers, Florida, United States Recruiting
• Covenant Metabolic Specialist
  Riverview, Florida, United States Recruiting
• Covenant Metabolic Specialist
  University Park, Florida, United States Recruiting

Study contacts

• Study coordinator: Ashley Magnavita
• Email: amagnavita@madrigalpharma.com
• Phone: +1 267-806-1293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.