RecruitingPhase 2NCT05067621

Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty 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)


Sponsor

Yale University

Enrollment

60 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 10 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests semaglutide (a weekly injection medication used for type 2 diabetes and obesity) in obese children and teenagers who have prediabetes, new-onset type 2 diabetes, and fatty liver disease (NAFLD). The goal is to see if semaglutide improves liver fat, blood sugar control, and metabolic health in this young population. **You may be eligible if...** - You are aged 10–20 with obesity (BMI ≥ 85th percentile) and have prediabetes or new-onset type 2 diabetes (diagnosed within 24 months) - You have fatty liver disease with ≥ 8% liver fat on imaging - You weigh at least 54 kg and are in puberty (Tanner stage II–IV) - If on metformin, you have been on a stable dose for up to 12 months **You may NOT be eligible if...** - Your type 2 diabetes has been present for more than 24 months - You have kidney problems, elevated enzymes, or are otherwise not in good general health - You are pregnant or may become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Pen Injector

Semaglutide (Wegovy) pen is a subcutaneous injection that contains 2.4mg/0.75mL of active ingredient. The injection pen can deliver doses of 0.24mg, 0.5mg, 1.0mg, 1.7mg, and 2.4mg.

DRUGPlacebo

Injection pen contains excipients.


Locations(1)

Pediatric Diabetes Center

New Haven, Connecticut, United States

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NCT05067621


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