Nutrition Intervention Combined With Resmetirom for 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
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
Treatments tested in this trial
- Resmetirom therapy
- Comprehensive nutritional intervention
- Standard dietary support
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov