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New treatment option for Metabolic-dysfunction Associated Steatotic Liver Disease
Official title SMART Diets for MASLD
ClinicalTrials.gov ID: NCT07459504
What this study is testing
What is Essential Amino Acids Supplementation intervention?
Essential Amino Acids Supplementation intervention is an investigational medicine, being studied as a potential treatment for metabolic-dysfunction associated steatotic liver disease.
Also referred to as EAA, AMS2392.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 17
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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)...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.