Nutrition Intervention Combined With Resmetirom for MASH

Part of paid clinical trials in New York, New York.

Sponsor
City University of New York
Study ID
NCT07680478
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Resmetirom therapy — DRUG
    All participants involved in the study will receive treatment according to resemetirom protocol: For patients weighing: * \<100 kg, the recommended dosage is 80 mg orally, once daily * ≥100 kg, the recommended dosage is 100 mg orally, once daily
  • Comprehensive nutritional intervention — BEHAVIORAL
    The nutritional intervention will consist of two components: 1. Medically tailored meals (MTMs): Participants will receive 10 MTMs per week delivered by God's Love We Deliver in New York City. Meals will follow Mediterranean diet principles (40% carbohydrate, 35-45% fat, 15-25% protein), be delivered frozen with preparation and safety instructions, and meal preferences will be collected in advance. Participants will be encouraged to eat two meals per weekday and source any additional food independently. 2. Nutritional and physical activity educational support: Online educational materials will be provided at baseline and follow-up visits, covering healthy eating, Mediterranean-diet principles, and exercise recommendations.
  • Standard dietary support — BEHAVIORAL
    Participants will receive standard-of-care lifestyle recommendations, including handouts on healthy diet and physical activity, and the option of a telehealth consultation with a dietitian.

Study Details

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 Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Resmetirom plus medically tailored meals and lifestyle education
    Participants receive resmetirom once daily by weight-based dosing (80 mg if \<100 kg; 100 mg if ≥100 kg) plus 10 medically tailored meals per week based on Mediterranean-diet principles, along with online nutrition and physical activity education at baseline and follow-up.
  • Active Comparator: Resmetirom plus standard-of-care lifestyle education
    Participants receive the same resmetirom protocol once daily by weight-based dosing (80 mg if \<100 kg; 100 mg if ≥100 kg), plus healthy diet and physical activity handouts and the option of a telehealth consultation with a dietitian.

Primary Outcome Measure

MRI-PDFF change [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CUNY Graduate School of Public Health and Health PolicyNew YorkNew York10027
Saba Mohamed Bibi
[email protected]
932 27 18 06

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By research site
CUNY Graduate School of Public Health and Health Policy· New York, NY

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