Nutrition Intervention Combined With Resmetirom for MASH

NCT07680478 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: GR-00013739
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Keywords

MASLD/MASH; Resmetirom therapy; Medically tailored meal (MTM); Nutrition-based intervention

Outcome Measures

Primary Outcomes (2)

• MRI-PDFF change

  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

  Baseline and 12 months

• MRE change

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

  Baseline and 12 months

Secondary Outcomes (7)

• Controlled attenuation parameter (CAP) change

  Baseline, 6 months and 12 months

• Vibration-controlled transient elastography (VCTE) responder

  Baseline, 6 months and 12 months

• Plasma LDL-C responder

  Baseline, 6 months and 12 months

• Triglyceride responder

  Baseline, 6 and 12 months

• Apolipoprotein B change

  Baseline, 6 and 12 months

Other Outcomes (21)

• Weight reduction

  Baseline, 6 months and 12 months

• Waist to hip ratio

  Baseline, 6 months and 12 months

• BMI

  Baseline, 6 and 12 months

Study Arms (2)

Resmetirom plus medically tailored meals and lifestyle education

EXPERIMENTAL

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.

Drug: Resmetirom therapy; Behavioral: Comprehensive nutritional intervention

Resmetirom plus standard-of-care lifestyle education

ACTIVE COMPARATOR

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.

Drug: Resmetirom therapy; Behavioral: Standard dietary support

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

Resmetirom plus medically tailored meals and lifestyle education; Resmetirom plus standard-of-care lifestyle education

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.

Resmetirom plus medically tailored meals and lifestyle education

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.

Resmetirom plus standard-of-care lifestyle education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• City University of New York: lead

Study Sites (1)

CUNY Graduate School of Public Health and Health Policy

New York, New York, 10027, United States

Location

Central Study Contacts

Jeffrey V. Lazarus

CONTACT

+1 646-364-9600; Jeffrey.Lazarus@sph.cuny.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Health

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

US (1)