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Resmetirom with Nutrition for MASH

This study is looking at how combining a nutrition program with resmetirom therapy affects liver health in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH). Resmetirom is the first approved medication for MASH. The study will compare patients who receive resmetirom plus a comprehensive nutrition plan (including medically tailored meals) to those who receive resmetirom with standard diet advice. We hope that adding the nutrition program will lead to better liver health improvements. You may be able to join if you are 18-75 years old, have non-cirrhotic MASH (meaning MASH without severe scarring of the liver) with moderate to severe fibrosis (F2-F3), and live in one of the five New York City boroughs. The study aims to enroll 120 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants are assigned by chance to one of two groups. It will involve 120 adults with MASH.
What's involved
You would have assessments at the beginning and after 12 months, including medical history, lifestyle questions, blood tests, and imaging to check your liver.
Compensation
Not stated in the trial record.
Follow-up
Liver health changes will be measured at 12 months, indicating the study duration for these primary outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07680478

Nutrition Intervention Combined With Resmetirom for MASH

Not Yet Recruiting
PHASE4Ages 18–75InterventionalTreatment
City University of New York
~120 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Resmetirom therapyComprehensive nutritional interventionStandard dietary support

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MRI-PDFF change
Measured over Baseline and 12 months
+1 more outcome measured

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

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NCT07680478

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CUNY Graduate School of Public Health and Health Policy

    New York, New Yorkstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jeffrey V. Lazarus
[email protected]
+1 646-364-9600
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • MRI-PDFF changeBaseline and 12 months

    Magnetic resonance imaging derived proton-density-fat-fraction (MRI-PDFF) will be used to evaluate liver steatosis. Absolute change in MRI-PDFF (%) between the two groups at month 12, as an indicator for steatosis change

  • MRE changeBaseline and 12 months

    Magnetic resonance elastography (MRE) will be used to evaluate liver fibrosis. Absolute change in MRE (kPa) between the two groups at month 12