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HomeTrials › NCT05067621

Obesity & weight · Phase 2 · Active, not recruiting

Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT05067621 · Sponsor: Yale University

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Semaglutide Pen Injector, Placebo for type 2 diabetes mellitus, impaired glucose tolerance, non-alcoholic fatty liver disease.

Who can joinAll sexes, 10 Years – 21 Years
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide Pen Injector, Placebo
Study length~3.4 years overall
Planned participants60
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Connecticut

  • Pediatric Diabetes Center — New Haven

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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