Can a weekly shot help obese teens avoid diabetes and fatty liver?
NCT ID NCT05067621
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether semaglutide (Wegovy), a once-weekly injection, can preserve the pancreas's ability to produce insulin and reduce liver fat in 60 obese youth with prediabetes or early type 2 diabetes and fatty liver disease. Participants receive either semaglutide or a placebo for 6 months, and researchers measure changes in beta-cell function and liver fat content. The goal is to see if this drug can slow disease progression in this high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide (Wegovy), a once-weekly injection
- What this could lead to
- If successful, this could point toward a treatment that slows or prevents progression from prediabetes to type 2 diabetes and reduces liver fat in obese youth.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply broadly. The benefits may be modest or not sustained after stopping the drug.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Jul 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pediatric Diabetes Center
New Haven, Connecticut, 06511, United States
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Other studies related to the condition(s) this trial covers.
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