Metabolic-dysfunction Associated Steatotic Liver DiseasePhase 2NCT07459504
SMART Diets for MASLD
A Phase 2 study testing Essential Amino Acids Supplementation intervention and Low sugar diet in people with Metabolic-dysfunction Associated Steatotic Liver Disease, run by Michigan State University at 1 site in United States.
Trial summary
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Metabolic-dysfunction Associated Steatotic Liver Disease
- What is being tested?
- Essential Amino Acids Supplementation intervention and Low sugar diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to 26 Dec 2030
- Phase
- Phase 2
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 11 to 17-years-old at the time of consenting
- Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
- At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age/sex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130/80 and/or signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU/mL in prepubertal children and of 17 pIU/mL and 13 pIU/mL in pubertal girls and boys, respectively, OR Prediabetes)
- ALT greater than or equal to 40 U/L
- Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.
- Patients of childbearing potential agrees to use adequate one or more effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Patients who are taking medications that can affect insulin (e.g., metformin, corticosteroids), most be on a stable dosage for at least 3 months prior to enrollment of the trial.
- Written informed consent from parent or legal guardian, assent from child.
Who cannot join
- Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of >6.5 mg/dL at baseline
- Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.
- Patients unable to complete MRI or Labs required for the study.
- Current participation in another clinical trial
- Current participation in a weight loss program or obesity treatment program or clinic
- Cancer or history of cancer within 5 years
Show all 18Show fewer
- Severe illness that required hospitalization in the last 60 days
- Use of medications known to cause liver steatosis (TPN, amiodarone, chronic oral steroids, etc.)
- Patients with implanted metal devices that are not compatible with magnetic resonance imaging (MRI).
- Intellectual disability or major psychiatric disorder limiting informed assent
- Clinical evidence of cirrhosis or advanced liver disease by any one of the following abnormal labs: (Hemoglobin less than 10 g/dL, White blood cell less than 3,500 cells/mm, Neutrophil count less than 1,500 cells/mm3 of blood, Platelets less than 130,000 cells/mm3 of blood, Direct bilirubin greater than 1.0 mg/dL)
- Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range.
- Albumin less than 3.2 g/dL
- A history of international normalized ratio (INR) greater than 1.4
- AST or ALT greater than 250 IU/dL.
- Compensated or decompensated cirrhosis with evidence of portal hypertension.
- Patients is pregnant or breastfeeding.
- Patients who have been enrolled in a recent clinical trial and had the last dose of investigational product within 30 days or 5 half-lives of the study drug, whichever is longer.
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, 1 recruiting
- Recruiting
Corewell Health West
Grand Rapids, Michigan, 49503
Renee Stuller, RN, 616-391-2460, renee.stuller@corewellhealth.org
Miriam B Vos, MD, MSPH
About this study
Official title: A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
Read the detailed description
Metabolic-dysfunction associated steatotic liver disease is defined as the presence of abnormal hepatic stored triglycerides (hepatic steatosis), with one or more of 5 cardiometabolic factors (increased body mass index or waist circumference, hyperglycemia, hypertriglyceridemia, or low HDL) and no other chronic liver disease. Pediatric hepatic steatosis is central to long-term metabolic and cardiovascular health because of the relation of hepatic steatosis to the development of other major diseases. Hepatic steatosis limits the normal metabolic role of insulin and plays a key role in the future development of the metabolic syndrome, and is the strongest predictor for the development of type 2 diabetes.
- Being tested
- Essential Amino Acids Supplementation intervention, Low sugar diet
- Keywords
- MASLD, Adolescents, Liver, Sugar, Amino acid supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino Acids Supplementation interventionDrug
Also called EAA, AMS2392
EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine
Low sugar dietOther
The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acids Supplementation | Active comparator | The essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase. Receives: Drug: Essential Amino Acids Supplementation intervention |
| Low Sugar Diet | Active comparator | The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods. Receives: Other: Low sugar diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic steatosis
Change in hepatic steatosis by magnetic resonance imaging (MRI)
Measured: Baseline to 24 weeks
Secondary outcomes (15)
Change in fasting triglyceride
Change in triglyceride in mg/dL
Measured: Baseline, 12 and 24 weeks
Change in HDL
Change in HDL mg/dL
Measured: Baseline, 12 and 24 weeks
Change in VLDL-triglyceride
Very-low-density-lipoprotein triglyceride
Measured: Baseline, 12 and 24 weeks
Change in Waist circumference
Change in Waist circumference in cm
Measured: Baseline, 12 and 24 weeks
Change in body weight
Change in weight in kilograms
Measured: Baseline, 12 and 24 weeks
Change in BMI Z Score
Change in body mass index z-score
Measured: Baseline, 12 and 24 weeks
Change in Alanine Aminotransferase (ALT)
Change in ALT
Measured: Baseline, 12 and 24 weeks
Aspartate Aminotransferase (AST)
Change in AST
Measured: Baseline, 12 and 24 weeks
Gamma glutamyl transferase (GGT)
Change in GGT
Measured: Baseline, 12 and 24 weeks
Systolic blood pressure
Change in systolic blood pressure mg/dL
Measured: Baseline, 12 and 24 weeks
Diastolic blood pressure
Change in diastolic blood pressure (mg/dL)
Measured: Baseline, 12 and 24 weeks
Hemoglobin A1c
Change in hemoglobin A1c
Measured: Baseline, 12 and 24 weeks
HOMA-IR
Change in homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: Baseline, 12 and 24 weeks
Adverse events
Number of adverse events compared between arms of the study
Measured: Baseline, 12 and 24 weeks
Percent responders
Percent of participants who reduce hepatic steatosis in the group that start with low sugar diet compared to the group that starts with EAA intervention
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startJun 2026 (estimated)
- Primary completion26 Dec 2029 (estimated)
- Study completion26 Dec 2030 (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 Steatotic Liver DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, multiple-assignment randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Corewell Health West, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Miriam B. Vos, Michigan State University
- Investigators
- Miriam B Vos, MD, MSPH, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459504
- Sponsor's protocol ID
- CHW-2026-1283
- Other IDs
- 1R61HL174736-01A1
- Status last verified
- May 2026
- First submitted
- 17 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include data from approximately 102 participants at up to 3 time-points. The final scientific datasets will include intervention assignment, anthropometrics, laboratory and imaging data. All protected health information and personally identified information will be removed. The study dates will be removed. Scientific data from the primary and secondary endpoints, along with a detailed data dictionary, and study protocols will be made available on a data repository such as Emory DataVerse. Genetic information for participants will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth
- ClinicalTrials.gov ID
- NCT07459504
- Acronym / sponsor ID
- CHW-2026-1283
- Keywords
- MASLD, Adolescents, Liver, Sugar, Amino acid supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Emory University, Corewell Health West, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2026 (estimated)
- Primary completion
- 26 Dec 2029 (estimated)
- Study completion
- 26 Dec 2030 (estimated)
- First posted
- 9 Mar 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 phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
Detailed description
Metabolic-dysfunction associated steatotic liver disease is defined as the presence of abnormal hepatic stored triglycerides (hepatic steatosis), with one or more of 5 cardiometabolic factors (increased body mass index or waist circumference, hyperglycemia, hypertriglyceridemia, or low HDL) and no other chronic liver disease. Pediatric hepatic steatosis is central to long-term metabolic and cardiovascular health because of the relation of hepatic steatosis to the development of other major diseases. Hepatic steatosis limits the normal metabolic role of insulin and plays a key role in the future development of the metabolic syndrome, and is the strongest predictor for the development of type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential, multiple-assignment randomized trial
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acids Supplementation | Active comparator | Drug: Essential Amino Acids Supplementation interventionThe essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase. |
| Low Sugar Diet | Active comparator | Other: Low sugar dietThe Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children 11 to 17-years-old at the time of consenting
- Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
- At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age/sex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130/80 and/or signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU/mL in prepubertal children and of 17 pIU/mL and 13 pIU/mL in pubertal girls and boys, respectively, OR Prediabetes)
- ALT greater than or equal to 40 U/L
- Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.
Key exclusion criteria (18 listed)
- Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of >6.5 mg/dL at baseline
- Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.
- Patients unable to complete MRI or Labs required for the study.
- Current participation in another clinical trial
- Current participation in a weight loss program or obesity treatment program or clinic
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 |
|---|---|---|
| Essential Amino Acids Supplementation interventionAlso: EAA, AMS2392EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine | Drug | Essential Amino Acids Supplementation |
| Low sugar dietThe Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods. | Other | Low Sugar Diet |
Primary outcome
Change in hepatic steatosis
Time frame: Baseline to 24 weeks
Change in hepatic steatosis by magnetic resonance imaging (MRI)
15 secondary outcomes
Change in fasting triglyceride
Time frame: Baseline, 12 and 24 weeks
Change in HDL
Time frame: Baseline, 12 and 24 weeks
Change in VLDL-triglyceride
Time frame: Baseline, 12 and 24 weeks
Change in Waist circumference
Time frame: Baseline, 12 and 24 weeks
Change in body weight
Time frame: Baseline, 12 and 24 weeks
Change in BMI Z Score
Time frame: Baseline, 12 and 24 weeks
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline, 12 and 24 weeks
Aspartate Aminotransferase (AST)
Time frame: Baseline, 12 and 24 weeks
Gamma glutamyl transferase (GGT)
Time frame: Baseline, 12 and 24 weeks
Systolic blood pressure
Time frame: Baseline, 12 and 24 weeks
Diastolic blood pressure
Time frame: Baseline, 12 and 24 weeks
Hemoglobin A1c
Time frame: Baseline, 12 and 24 weeks
HOMA-IR
Time frame: Baseline, 12 and 24 weeks
Adverse events
Time frame: Baseline, 12 and 24 weeks
Percent responders
Time frame: Baseline to 24 weeks
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 1 Jun 2026.
- Individual participant dataSharing planned: Yes. The proposed research will include data from approximately 102 participants at up to 3 time-points. The final scientific datasets will include intervention assignment, anthropometrics, laboratory and imaging data. All protected health information and personally identified information will be removed. The study dates will be removed. Scientific data from the primary and secondary endpoints, along with a detailed data dictionary, and study protocols will be made available on a data repository such as Emory DataVerse. Genetic information for participants will not be made available.
Related trials for Metabolic-dysfunction Associated Steatotic Liver Disease
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingObservational study
Clinical Profile of Patients With MASLD in Kazakhstan and Clinical Effectiveness of Ursosan in Almaty
Metabolic Dysfunction-Associated Steatotic Liver Disease
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.
Miriam B Vos, MD, MSPH principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Essential Amino Acids Supplementation intervention and Low sugar diet in people with Metabolic-dysfunction Associated Steatotic Liver Disease, run by Michigan State University 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 1 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Miriam B Vos, MD, MSPH (616-267-2100, miriam.vos@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic steatosis (time frame: Baseline to 24 weeks). 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 1 Jun 2026.