NCT07680478Not yet recruitingPhase 4
Nutrition Intervention Combined With Resmetirom for MASH
Assessing Nutrition-aligned Resmetirom Roll-out
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Jun 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- City University of New York
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07680478
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Oct 2026 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have cirrhosis or decompensated liver disease
- Have other chronic liver diseases
- 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
Other
- Are pregnant or breastfeeding
- Consume alcohol above defined thresholds or have PEth =20 ng/mL
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CUNY Graduate School of Public Health and Health Policy Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.