🏛️ Verified NIH Record • Updated 2026-07-02

Nutrition Intervention Combined With Resmetirom for MASH (NCT07680478)

Assessing Nutrition-aligned Resmetirom Roll-out

🟡 Not Yet Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: City University of New York

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: CUNY Graduate School of Public Health and Health Policy — New York, New York

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • CUNY Graduate School of Public Health and Health Policy — New York, New York

📞 Contact the Study Coordinator

Phone: (646) 364-9600

Email: Jeffrey.Lazarus@sph.cuny.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Explore by condition: All Metabolic Dysfunction-Associated Steatohepatitis (MASH) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗