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.
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
Patients with cirrhosis and other etiologies of chronic liver disease
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.
Active hyperthyroidism
Untreated clinical hypothyroidism defined by TSH >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms
Parallel
Resmetirom
DrugResmetirom (80 mg or 100 mg orally once daily based on body weight)
Placebo
DrugMatching placebo orally once daily
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent serious adverse events (SAES)
Change from baseline in physical examination findings assessed by investigator physical examination
Physical examination findings will be assessed by the Investigator and include general appearance, skin, head and neck, heart, lungs, abdomen, extremities, and neuromuscular assessments. After Screening and successful Randomization, physical examinations may be targeted to evaluation of new symptoms or signs.
Change from baseline in body temperature
Body temperature will be measure in °C, resting heart rate in beats per minute, respiratory rate in breaths per minute, systolic blood pressure in mmHg, and diastolic blood pressure in mmHg
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