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Could a tailored diet make a MASH drug work better?

NCT ID NCT07680478

Disease control Sponsor: City University of New York Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests whether adding a Mediterranean-style meal delivery program to resmetirom therapy improves liver health more than resmetirom alone. It involves 120 adults with non-cirrhotic MASH who are starting resmetirom. Participants either receive the drug plus 10 medically tailored meals per week or the drug alone, and liver fat and stiffness are measured after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Resmetirom
What this could lead to
If it works, this could show that combining a liver-targeting drug with a tailored diet leads to better liver health than the drug alone.
What could go wrong
This is a mid-stage trial with only 120 participants, so results may not apply to everyone. The diet program is limited to New York City, and the drug may cause side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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: * Provide informed consent * Be 18-75 years old * Have non-cirrhotic MASH with fibrosis stage F2-F3 (VCTE 8-20 kPa and CAP =280 dB/m) * Be initiating resmetirom per standard of care * Be able to comply with study procedures, including fasting visits * Reside in one of the five New York City boroughs Exclusion Criteria: * Have cirrhosis or decompensated liver disease * Have other chronic liver diseases * Are pregnant or breastfeeding * Consume alcohol above defined thresholds or have PEth =20 ng/mL * Have recent major surgery or hospitalization * Are on glucagon-like peptide-1 agonist therapy (e.g., exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), unless the dose is stable for 12 weeks prior to the baseline evaluation and they have not experienced a \>5% weight loss in the 6 months preceding resmetirom initiation. * Are undergoing bariatric surgery * Are living with any other end-stage organ disease (e.g., heart, lung or kidney failure requiring dialysis) or have any active malignancy in the last 5 years. * Have conditions preventing consumption of provided meals

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction associated steatohepatitis (MASH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • CUNY Graduate School of Public Health and Health Policy

    New York, New York, 10027, United States

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