Can a liver drug help patients with fatty liver disease and a stiff heart?
NCT ID NCT07830758
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing resmetirom, an oral drug, in adults who have metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). The trial assigns participants to receive resmetirom or a placebo for 24 weeks. The main goals are to check safety and tolerability and to measure changes in liver fat using MRI. About 90 people will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- resmetirom, an oral drug that targets the liver
- What this could lead to
- If resmetirom proves safe and affects liver fat in this population, it could support further testing as a treatment for people who have both MASH and HFpEF.
- What could go wrong
- This is an early-stage trial with about 90 participants, so it may not show clear benefit or may reveal side effects that stop further development. Results in this specific group may not apply to others.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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