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NCT07680478 · ClinicalTrials.gov registry record · Phase 4
Nutrition Intervention Combined With Resmetirom for MASH
A Phase 4 study, sponsored by City University of New York.
- Not yet
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT07680478: Clinical Trial Phase 4 study, sponsored by City University of New York.
NCT07680478 is a Phase 4 study that has not yet begun recruiting, run by City University of New York. The registered enrollment target is 120 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07680478, a Phase 4 study, has not yet begun recruiting, sponsored by City University of New York.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Resmetirom therapy
- BEHAVIORAL Comprehensive nutritional intervention
- BEHAVIORAL Standard dietary support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 4 |
What is known before NCT07680478 opens enrollment
NCT07680478 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Resmetirom therapy is the first listed.
NCT07680478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07680478 about?
NCT07680478 is a clinical study titled "Nutrition Intervention Combined With Resmetirom for MASH". 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 improvi...
What is the current status of trial NCT07680478?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2026-10-01. Estimated completion is 2028-06-30.
What interventions are being tested in trial NCT07680478?
The interventions under investigation include: Resmetirom therapy (DRUG), Comprehensive nutritional intervention (BEHAVIORAL), Standard dietary support (BEHAVIORAL).
Who is sponsoring clinical trial NCT07680478?
This trial is sponsored by City University of New York, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07680478's enrollment target sits among peer trials
120 673rd of 2000 higher than 1,289 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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