[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645258":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":27,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":27,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":27,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"City University of New York","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Resmetirom plus medically tailored meals and lifestyle education","EXPERIMENTAL","Participants receive resmetirom once daily by weight-based dosing (80 mg if \\\u003C100 kg; 100 mg if ≥100 kg) plus 10 medically tailored meals per week based on Mediterranean-diet principles, along with online nutrition and physical activity education at baseline and follow-up.",[13,14],"Drug: Resmetirom therapy","Behavioral: Comprehensive nutritional intervention",{"label":16,"type":17,"description":18,"interventionNames":19},"Resmetirom plus standard-of-care lifestyle education","ACTIVE_COMPARATOR","Participants receive the same resmetirom protocol once daily by weight-based dosing (80 mg if \\\u003C100 kg; 100 mg if ≥100 kg), plus healthy diet and physical activity handouts and the option of a telehealth consultation with a dietitian.",[13,20],"Behavioral: Standard dietary support",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Resmetirom therapy","All participants involved in the study will receive treatment according to resemetirom protocol:\n\nFor patients weighing:\n\n* \\\u003C100 kg, the recommended dosage is 80 mg orally, once daily\n* ≥100 kg, the recommended dosage is 100 mg orally, once daily",[9,16],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"BEHAVIORAL","Comprehensive nutritional intervention","The nutritional intervention will consist of two components:\n\n1. Medically tailored meals (MTMs): Participants will receive 10 MTMs per week delivered by God's Love We Deliver in New York City. Meals will follow Mediterranean diet principles (40% carbohydrate, 35-45% fat, 15-25% protein), be delivered frozen with preparation and safety instructions, and meal preferences will be collected in advance. Participants will be encouraged to eat two meals per weekday and source any additional food independently.\n2. Nutritional and physical activity educational support: Online educational materials will be provided at baseline and follow-up visits, covering healthy eating, Mediterranean-diet principles, and exercise recommendations.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Standard dietary support","Participants will receive standard-of-care lifestyle recommendations, including handouts on healthy diet and physical activity, and the option of a telehealth consultation with a dietitian.",[16],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Jeffrey V. Lazarus","CONTACT","+1 646-364-9600","Jeffrey.Lazarus@sph.cuny.edu",[44],{"facility":45,"status":27,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CUNY Graduate School of Public Health and Health Policy","New York","10027","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":59,"phoneExt":27,"email":60},"Saba Mohamed Bibi","932 27 18 06","saba.mohamed@isglobal.org",{"type":62,"investigatorFullName":39,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Professor of Global Health","100645258","phase-4-nutrition-intervention-combined-with-resmetirom-for-mash-100645258",false,"NCT07680478","Nutrition Intervention Combined With Resmetirom for MASH","Assessing Nutrition-aligned Resmetirom Roll-out","NOURISH-MASH","Inclusion Criteria:\n\n* Provide informed consent\n* Be 18-75 years old\n* Have non-cirrhotic MASH with fibrosis stage F2-F3 (VCTE 8-20 kPa and CAP =280 dB\u002Fm)\n* Be initiating resmetirom per standard of care\n* Be able to comply with study procedures, including fasting visits\n* Reside in one of the five New York City boroughs\n\nExclusion Criteria:\n\n* Have cirrhosis or decompensated liver disease\n* Have other chronic liver diseases\n* Are pregnant or breastfeeding\n* Consume alcohol above defined thresholds or have PEth =20 ng\u002FmL\n* Have recent major surgery or hospitalization\n* 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.\n* Are undergoing bariatric surgery\n* 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.\n* Have conditions preventing consumption of provided meals","ALL","18 Years","75 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","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.",[83],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[85,24,86,87],"MASLD\u002FMASH","Medically tailored meal (MTM)","Nutrition-based intervention","NOT_YET_RECRUITING","2026-06-25",{"date":91,"type":92},"2026-07-02","ACTUAL",{"date":94,"type":77},"2026-10-01",{"date":96,"type":77},"2028-06-30",{"name":5,"class":6},1]