What is Orforglipron studying for obesity or overweight in children and teens?

Orforglipron is being studied to see how safe and effective it is for managing chronic weight in young people with obesity or overweight. This study aims to evaluate this drug as part of a larger effort to find treatment options. Eli Lilly and Company is sponsoring the research to help improve pediatric weight management.

Who may be eligible for this obesity or overweight clinical trial?

Children and teens aged 6 to 17 with obesity or overweight may be eligible. Participants should have tried diet and exercise programs without success and meet specific BMI criteria. Those with certain medical conditions or recent significant weight loss may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity or overweight clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend scheduled visits for assessments throughout the study.

Actively Recruiting

Phase 3

Age: 6Years - 17Years

All Genders

ID06672549

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

Led by Eli Lilly and Company · Updated on 2026-05-19

125

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for obesity or overweight in children and teenagers aged 6 to 17. This phase 3 pediatric chronic weight management study aims to create a framework to evaluate the safety and effectiveness of medicines for managing weight in this young population. The study is designed as a master protocol, allowing multiple interventions to be tested independently as they become available. Participants will be randomly assigned to receive either the drug Orforglipron or a placebo, both given by mouth. Each intervention will follow specific details within the study arms. The study periods include enrollment under the master protocol and independent substudies for each intervention. Results will be reported when all intervention substudies are completed. Throughout the study, participants will have regular assessments to monitor their weight and health. Researchers will track the number of participants assigned to each intervention from the start through week 72. The study includes evaluations of safety and effect on body weight, with ongoing monitoring to understand the impact of the treatments. Total participation may last up to about 72 weeks, with periodic visits and evaluations.

CONDITIONS

Brief Title

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Who Can Participate

Age: 6Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Have a history of at least 1 unsuccessful effort to lose weight after a structured lifestyle program of diet and exercise counseling for at least 3 months before screening.
Obesity defined as BMI equal to or above the 95th percentile for age and sex on the CDC-NCHS 2022 growth chart.
For participants aged 12 to under 18 years, overweight defined as BMI between the 85th and 95th percentile for age and sex with at least one weight-related condition such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, or metabolic dysfunction-associated liver disease.

You will not qualify if you...

Have had or plan to have weight reduction surgery during the study, including gastric bypass, sleeve gastrectomy, Lap-Band gastric banding, or other weight loss procedures.
Have a diagnosis of a secondary cause of obesity or abrupt onset of obesity suggesting such causes like hypothalamic, monogenetic, syndromic, or endocrine disorders.
Have lost more than 5 kg (11 lbs) in the 90 days before screening.
Have type 1 diabetes or history of ketoacidosis or hyperosmolar state.
Have HbA1c greater than 9.0% as measured at screening.
Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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