Nutrition Intervention Combined With Resmetirom for MASH

Starting soon · Phase 4

Conditions studied: Metabolic Dysfunction-Associated Steatohepatitis (MASH)

In brief

This randomized control trial aims to evaluate the effectiveness of combining resmetirom therapy (first approved pharmacological therapy for treating metabolic dysfunction-associated steatohepatitis (MASH)) with a nutritional intervention compared to resmetirom therapy alone over one year in improving liver health among 120 patients living with non-cirrhotic MASH. We hypothesize that patients receiving resmetirom and nutritional intervention will experience more significant improvements in liver function than those receiving only resmetirom therapy.

Key facts

Study ID

NCT07680478

Run by

City University of New York

People needed

120

Starts

2026-10-01

Expected to finish

2028-06-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CUNY Graduate School of Public Health and Health Policy — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.