Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07459504
Eligibility Criteria:
Inclusion 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 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.
Exclusion Criteria:
* 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
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT07459504
Study Brief:
Protocol Section:
NCT07459504