Resmetirom in Patients With MASH and HFpEF
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants are randomized 2:1 to resmetirom or placebo for 24 weeks."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of resmetirom and its effects on the liver in adults with MASH and HFpEF. MASH is fatty liver disease with swelling and damage; HFpEF is heart failure where the heart still pumps a normal share of blood. Participants receive resmetirom or a placebo (a pill with no study drug) for 24 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and agree in writing to join.
- Have suspected or confirmed MASH with liver scarring, and meet at least one study rule for this condition.
- Have confirmed HFpEF.
- Have a heart ultrasound showing a problem with the heart’s structure or how it works.
- Have an eGFR of at least 45, a blood test measure of kidney function.
- If able to become pregnant: have a negative blood pregnancy test, not breastfeed or plan pregnancy, and use highly effective birth control during the study and for at least 30 days after taking the study drug.
Who can't join
- Have cirrhosis (severe liver scarring), another cause of long-term liver disease, liver cancer, poor liver function, or a liver disease severity score called MELD of 12 or higher.
- Have a PEth alcohol blood test of 20 ng/mL or higher, or a history of significant drinking for more than 3 months in a row within the past year.
- Have an active overactive thyroid, or an untreated underactive thyroid that meets the study’s blood test and symptom rules.
- Have had weight-loss or intestinal bypass surgery within 5 years, plan it during the study, or have had surgery to redirect bile. Gaining or losing more than 5% of body weight within 12 weeks also excludes you.
- Have an HbA1c above 9% (high average blood sugar), or certain active or severe autoimmune diseases, where the immune system attacks the body.
- Have ALT above 250 U/L (a liver blood test) or platelets below 140,000 (blood cells that help stop bleeding). Counts from 120,000 to below 140,000 are allowed if the FIB-4 liver scarring score is below 3.5.
- Have blood pressure above 170 for the top number or 100 for the bottom number.
- Have certain heart rhythm problems: a QTcF heart test above 450 milliseconds for men or 470 for women, ongoing atrial fibrillation (an irregular heartbeat), or episodes of it within the past 3 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (5)
AZ
- Arizona Clinical Trials · Peoria, AZ 85382More trials in Peoria
CA
- FOMAT - Clinicas Mi Salud · Oxnard, CA 93030More trials in Oxnard
FL
- Covenant Metabolic Specialist · Fort Myers, FL 33912More trials in Fort Myers
- Covenant Metabolic Specialist · Riverview, FL 33578More trials in Riverview
- Covenant Metabolic Specialist · University Park, FL 34201More trials in University Park