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Can a liver drug help patients with fatty liver disease and a stiff heart?

NCT ID NCT07830758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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