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NCT07680478
Nutrition Intervention Combined With Resmetirom for MASH
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 120
Sponsor: City University of New York
Location: CUNY Graduate School of Public Health and Health Policy New York New York
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT07680478). StuddyBuddy aggregates publicly available trial information.