Effects of Semaglutide on Obese Youth with Prediabetes and Liver Disease
Semaglutide, 2.4mg, Once Weekly: Effects on Beta-cell Preservation and Reduction of Intrahepatic Triglyceride Content in Obese Youth With Prediabetes (IGT)/Early Type 2 Diabetes (T2D) and Non-Alcoholic Fatty Liver Disease (NAFLD)
This study is testing if Semaglutide can help overweight young people aged 10 to 21 with prediabetes and liver disease by improving their blood sugar levels and reducing fat in their liver.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05067621 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Semaglutide, a GLP-1 analog, on obese youth aged 10 to 21 years who have prediabetes, new onset Type 2 Diabetes, and Non-Alcoholic Fatty Liver Disease (NAFLD). The study is designed as a randomized, double-blind, placebo-controlled trial, where participants will receive Semaglutide or a placebo for six months, followed by a three-month wash-out period. The goal is to understand how Semaglutide can help preserve beta-cell function and reduce liver fat in this population, addressing a critical need for effective treatments in youth-onset diabetes.
Who should consider this trial
Good fit: Ideal candidates are obese youth aged 10 to 21 years with prediabetes or new onset Type 2 Diabetes and NAFLD.
Not a fit: Patients with severe comorbidities or those not meeting the eligibility criteria, such as those outside the specified age range or with uncontrolled health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve metabolic health and prevent complications in obese youth with prediabetes and Type 2 Diabetes.
How similar studies have performed: Previous studies have shown promising results with GLP-1 analogs in managing Type 2 Diabetes, suggesting potential success for this approach in youth.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to \<200 mg/dl post-OGTT OR HbA1c ≥5.7% to \<6.5%), OR new-onset T2D (≤24 months duration, 2h glucose \>200 and HbA1c \>6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less) * PDFF of ≥ 8% * Male or female, aged 10 to \<21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study * Weight ≥ 54kg * BMI ≥ 85% but ≤ 40 kg/m2 * Good general health (normal kidney function, amylase, and lipase levels) * Informed consent from a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities (trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial) * Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol. Exclusion Criteria * Known or suspected hypersensitivity to trial product(s) or related products. * Receipt of any investigational medicinal product within 30 days before screening. * Prepubertal participants (Tanner stage 1) * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods. * Having a diagnosis of: * Type 1 diabetes o Maturity onset diabetes of the young (MODY) o History or presence of Pancreatitis (acute or chronic) o Presence of endocrinopathies (e.g., Cushing syndrome) o Cardiac, renal or pulmonary or other chronic illness o Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG, or new clinically significant arrhythmias or conduction delays on ECG identified at visit 1) o Family or personal history of MEN type 2 or medullary thyroid carcinoma (family is defined as a first-degree relative)o Any other disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol * Any laboratory safety parameter at screening outside the below extended laboratory ranges: o Baseline creatinine \>1.0mg o Hypertriglyceridemia)(\>500 mg/dl) * Calcitonin equal or above 50 ng/L at screening o Body Mass Index (BMI) ≤ 25.0 at the screening visit o ALT ≥5 times the upper normal limit (UNL) o Creatinine \>UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator * Known hypoglycemic unawareness. * Recurrent severe hypoglycemic episodes within the last year as judged by the investigator. * Uncontrolled hypertension treated or untreated \>99th percentile for age and gender in children and adolescents. * Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening. * Taking medication, based on the investigator's judgement, that may cause significant weight gain or loss (e.g., antipsychotic, steroid, anti-obesity medication). * Presence or history of malignant neoplasm within 5 years prior to the day of screening.Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. * Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. Mental health: * History of major depressive disorder within 2 years before screening * Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) * A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening * A lifetime history of suicidal attempt * Suicidal behavior within 30 days before screening * Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity * Rating Scale (C-SSRS) within the past 30 days before screening * Participants with confirmed diagnosis of bulimia nervosa disorder
Where this trial is running
New Haven, Connecticut
- Pediatric Diabetes Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Sonia Caprio, MD — Yale University
- Study coordinator: Julie Holub
- Email: julie.holub@yale.edu
- Phone: 203-785-5692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.