A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

6 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Semaglutide will be administered subcutaneously once weekly.
• Placebo — DRUG
  Placebo will be administered subcutaneously once-weekly.

Study Details

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults. The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Key Dates

Start date

Jul 7, 2023

Status verified

Apr 2026

Primary completion

Oct 15, 2025

Completion

Dec 7, 2026

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group Kids
  Participants in the age group 6 to less than (\<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
• Experimental: Group Teens
  Participants in the age group 12 to \< 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.

Primary Outcome Measure

Group Kids: Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to week 68 ]

Locations (24)

Related coverage on Hipa.ai

• Semaglutide Phase 3 Trial for Pediatric Obesity Completes Primary Data…
  Semaglutide · Oct 15, 2025 · ClinicalTrials.gov

Find similar trials in Escondido, CA

Related Studies

• Diabetes and Heart Disease Risk in Blacks
  Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
• Physical and Behavioral Traits of Overweight and Obese Adults
  Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
• Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Washington D.C., District of Columbia
• New Heart Imaging Techniques to Evaluate Possible Heart Disease
  Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland