Nutrition Intervention Combined With Resmetirom for MASH

ConditionMetabolic Dysfunction-Associated Steatohepatitis (MASH)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCity University of New York

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Resmetirom plus medically tailored meals and lifestyle educationExperimental treatment 2 interventions

Group B: Resmetirom plus standard-of-care lifestyle educationActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

Baseline and 12 months

Secondary outcomes

Controlled attenuation parameter (CAP) change

The CAP will be used to assess liver steatotis. Absolute change in CAP (dB/m) between the two groups at month 12

Time frame

Baseline, 6 months and 12 months

Vibration-controlled transient elastography (VCTE) responder

The VSTE will be used to assess liver fibrosis. The percentage of patients that achieve a ≥25% relative reduction at months 6 and 12, as compared with baseline VCTE (kPa)

Time frame

Baseline, 6 months and 12 months

Plasma LDL-C responder

The percentage of patients with plasma LDL-C \>100 mg/dL at baseline who are able to reduce it to \<100 mg/dL at months 6 and 12

Time frame

Baseline, 6 months and 12 months

Triglyceride responder

The percentage of patients with triglycerides \>150 mg/dL at baseline who are able to reduce it to \<150 mg/dL at months 6 and 12

Time frame

Baseline, 6 and 12 months

Other outcomes

Weight reduction

The percentage of patients that achieve a ≥5% relative reduction in weight (Kg) at months 6 and 12, as compared with baseline weight (Kg)

Time frame

Baseline, 6 months and 12 months

Waist to hip ratio

The waist-to-hip ratio will be calculated by dividing the waist circumference (cm) by the hip circumference (cm). Waist circumference will be measured at the narrowest part of the waist (or midway between the lowest rib and the top of the hip bone), and hip circumference will be measured at the widest part of the buttocks. A higher waist-to-hip ratio indicates a greater proportion of abdominal fat relative to hip circumference.

Time frame

Baseline, 6 months and 12 months

BMI

Body mass index (BMI) will be calculated by dividing a person's weight in kilograms by the square of their height in meters (weight \[kg\] ÷ height \[m²\]). BMI is commonly used as a screening measure to classify body weight relative to height and to identify categories such as underweight, normal weight, overweight, and obesity.

Time frame

Baseline, 6 and 12 months

Medication adherence

At each study visit, participants will bring any remaining resmetirom pills. Study staff will count the pills and compare this to the number dispensed. Adherence is defined as taking at least 80% of dispensed medication.

Time frame

3 months, 6 months, 9 months and 12 months

Sponsors and contacts

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City University of New York

Lead sponsor

Source ClinicalTrials.gov

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