Metabolic Dysfunction-Associated Steatohepatitis (MASH)Phase 4NOURISH-MASHNCT07680478
Nutrition Intervention Combined With Resmetirom for MASH
A Phase 4 study testing Resmetirom therapy, Comprehensive nutritional intervention and Standard dietary support in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by City University of New York at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- What is being tested?
- Resmetirom therapy, Comprehensive nutritional intervention and Standard dietary support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
CUNY Graduate School of Public Health and Health Policy
New York, New York, 10027
Saba Mohamed Bibi, 932 27 18 06, saba.mohamed@isglobal.org
About this study
Official title: Assessing Nutrition-aligned Resmetirom Roll-out
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.
Read the detailed description
On March 14, 2024, resmetirom, a selective thyroid hormone receptor-β agonist, became the first pharmacological therapy approved by the US Food and Drug Administration (FDA) for treating metabolic dysfunction-associated steatohepatitis (MASH). Although, lifestyle modification remains first-line MASH treatment the provision of resmetirom is rarely accompanied by structured non-pharmacological interventions, and evidence guiding the integration of nutrition-based strategies with pharmacotherapy is limited. This study aims to evaluate the effectiveness of a nutrition-based intervention, including medically tailored meal (MTM) and nutrition education provision combined with resmetirom therapy, compared with resmetirom therapy combined with standard-of-care lifestyle recommendations, in improving liver function.
This multi-site, prospective, randomised controlled trial will enroll 120 adults (18-75 years) with non-cirrhotic MASH and fibrosis stages F2-F3. Recruited participants will undergo baseline assessments including evaluation of medical history and lifestyle behaviors, completion of a food frequency questionnaire, blood pressure measurement, blood sampling, anthropometric measurements (weight, height, and waist and hip circumference), and assessment of liver steatosis and fibrosis using imaging methods. Upon completion of baseline evaluations, participants will be randomised 1:1 to receive either: (1) resmetirom plus standard-of-care lifestyle education (control); or (2) resmetirom plus a structured nutritional intervention consisting of MTM delivery and lifestyle education (intervention).
The primary endpoints are changes in liver steatosis and fibrosis at 12 months, assessed by imaging methods. Secondary endpoints include changes in blood-circulating lipids, alanine aminotransferase levels, metabolic parameters, anthropometrics, dietary quality, and lifestyle behaviours. Analyses will follow an intention-to-treat approach using regression models adjusted for relevant covariates.
Adherence assessments will be conducted at 3, 6, and 9 months, with outcome evaluations at 6 months and at the end of the study (12 months).
- Being tested
- Resmetirom therapy, Comprehensive nutritional intervention, Standard dietary support
- Keywords
- MASLD/MASH, Resmetirom therapy, Medically tailored meal (MTM), Nutrition-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resmetirom therapyDrug
All participants involved in the study will receive treatment according to resemetirom protocol:
For patients weighing:
- <100 kg, the recommended dosage is 80 mg orally, once daily
- ≥100 kg, the recommended dosage is 100 mg orally, once daily
Comprehensive nutritional interventionBehavioural
The nutritional intervention will consist of two components:
- 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.
- 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.
Standard dietary supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resmetirom plus medically tailored meals and lifestyle education | Experimental | Participants receive resmetirom once daily by weight-based dosing (80 mg if <100 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. Receives: Drug: Resmetirom therapy; Behavioral: Comprehensive nutritional intervention |
| Resmetirom plus standard-of-care lifestyle education | Active comparator | Participants receive the same resmetirom protocol once daily by weight-based dosing (80 mg if <100 kg; 100 mg if ≥100 kg), plus healthy diet and physical activity handouts and the option of a telehealth consultation with a dietitian. Receives: Drug: Resmetirom therapy; Behavioral: Standard dietary support |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-PDFF change
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
Measured: Baseline and 12 months
MRE change
Magnetic resonance elastography (MRE) will be used to evaluate liver fibrosis. Absolute change in MRE (kPa) between the two groups at month 12
Measured: Baseline and 12 months
Secondary outcomes (7)
Controlled attenuation parameter (CAP) change
The CAP will be used to assess liver steatotis. Absolute change in CAP (dB/m) between the two groups at month 12
Measured: Baseline, 6 months and 12 months
Vibration-controlled transient elastography (VCTE) responder
The VSTE will be used to assess liver fibrosis. The percentage of patients that achieve a ≥25% relative reduction at months 6 and 12, as compared with baseline VCTE (kPa)
Measured: Baseline, 6 months and 12 months
Plasma LDL-C responder
The percentage of patients with plasma LDL-C >100 mg/dL at baseline who are able to reduce it to <100 mg/dL at months 6 and 12
Measured: Baseline, 6 months and 12 months
Triglyceride responder
The percentage of patients with triglycerides >150 mg/dL at baseline who are able to reduce it to <150 mg/dL at months 6 and 12
Measured: Baseline, 6 and 12 months
Apolipoprotein B change
Change (%) from baseline in directly measured apolipoprotein B at months 6 and 12
Measured: Baseline, 6 and 12 months
Lp(α) change
Change (%) from baseline in directly measured Lp(α) in patients with baseline Lp(α) >10 nmol/L at months 6 and 12
Measured: Baseline, 6 and 12 months
ALT responder
The percentage of patients with ALT >30 IU/L at baseline with a >20% and/or 17 IU/L reduction at months 6 and 12
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey V. Lazarus, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680478
- Sponsor's protocol ID
- GR-00013739
- Acronym
- NOURISH-MASH
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Nutrition-aligned Resmetirom Roll-out
- ClinicalTrials.gov ID
- NCT07680478
- Acronym / sponsor ID
- NOURISH-MASH / GR-00013739
- Keywords
- MASLD/MASH, Resmetirom therapy, Medically tailored meal (MTM), Nutrition-based intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- City University of New YorkUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
On March 14, 2024, resmetirom, a selective thyroid hormone receptor-β agonist, became the first pharmacological therapy approved by the US Food and Drug Administration (FDA) for treating metabolic dysfunction-associated steatohepatitis (MASH). Although, lifestyle modification remains first-line MASH treatment the provision of resmetirom is rarely accompanied by structured non-pharmacological interventions, and evidence guiding the integration of nutrition-based strategies with pharmacotherapy is limited. This study aims to evaluate the effectiveness of a nutrition-based intervention, including medically tailored meal (MTM) and nutrition education provision combined with resmetirom therapy, compared with resmetirom therapy combined with standard-of-care lifestyle recommendations, in improving liver function.
This multi-site, prospective, randomised controlled trial will enroll 120 adults (18-75 years) with non-cirrhotic MASH and fibrosis stages F2-F3. Recruited participants will undergo baseline assessments including evaluation of medical history and lifestyle behaviors, completion of a food frequency questionnaire, blood pressure measurement, blood sampling, anthropometric measurements (weight, height, and waist and hip circumference), and assessment of liver steatosis and fibrosis using imaging methods. Upon completion of baseline evaluations, participants will be randomised 1:1 to receive either: (1) resmetirom plus standard-of-care lifestyle education (control); or (2) resmetirom plus a structured nutritional intervention consisting of MTM delivery and lifestyle education (intervention).
The primary endpoints are changes in liver steatosis and fibrosis at 12 months, assessed by imaging methods. Secondary endpoints include changes in blood-circulating lipids, alanine aminotransferase levels, metabolic parameters, anthropometrics, dietary quality, and lifestyle behaviours. Analyses will follow an intention-to-treat approach using regression models adjusted for relevant covariates.
Adherence assessments will be conducted at 3, 6, and 9 months, with outcome evaluations at 6 months and at the end of the study (12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resmetirom plus medically tailored meals and lifestyle education | Experimental | Drug: Resmetirom therapy, Behavioral: Comprehensive nutritional interventionParticipants receive resmetirom once daily by weight-based dosing (80 mg if <100 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. |
| Resmetirom plus standard-of-care lifestyle education | Active comparator | Drug: Resmetirom therapy, Behavioral: Standard dietary supportParticipants receive the same resmetirom protocol once daily by weight-based dosing (80 mg if <100 kg; 100 mg if ≥100 kg), plus healthy diet and physical activity handouts and the option of a telehealth consultation with a dietitian. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resmetirom therapyAll participants involved in the study will receive treatment according to resemetirom protocol: For patients weighing: * <100 kg, the recommended dosage is 80 mg orally, once daily * ≥100 kg, the recommended dosage is 100 mg orally, once daily | Drug | Resmetirom plus medically tailored meals and lifestyle education, Resmetirom plus standard-of-care lifestyle education |
| Comprehensive nutritional interventionThe nutritional intervention will consist of two components: 1. 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. 2. 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. | Behavioural | Resmetirom plus medically tailored meals and lifestyle education |
| Standard dietary supportParticipants 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. | Behavioural | Resmetirom plus standard-of-care lifestyle education |
Primary outcome
MRI-PDFF change
Time frame: Baseline and 12 months
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
MRE change
Time frame: Baseline and 12 months
Magnetic resonance elastography (MRE) will be used to evaluate liver fibrosis. Absolute change in MRE (kPa) between the two groups at month 12
7 secondary outcomes
Controlled attenuation parameter (CAP) change
Time frame: Baseline, 6 months and 12 months
Vibration-controlled transient elastography (VCTE) responder
Time frame: Baseline, 6 months and 12 months
Plasma LDL-C responder
Time frame: Baseline, 6 months and 12 months
Triglyceride responder
Time frame: Baseline, 6 and 12 months
Apolipoprotein B change
Time frame: Baseline, 6 and 12 months
Lp(α) change
Time frame: Baseline, 6 and 12 months
ALT responder
Time frame: Baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resmetirom therapy, Comprehensive nutritional intervention and Standard dietary support in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey V. Lazarus (+1 646-364-9600, Jeffrey.Lazarus@sph.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-PDFF change (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.