What is orforglipron studying for obesity or overweight in adolescents?

Orforglipron is being studied to see how well it works and how safe it is for adolescents with obesity or overweight with related health issues. The trial compares orforglipron taken once daily by mouth to a placebo to understand its effects. Eli Lilly and Company is sponsoring this research to help find better treatment options.

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

Participants aged 12 to 17 with obesity or overweight and at least one related health condition may be eligible. They should have tried to lose weight through diet and exercise counseling without enough success and not be prepubertal. Certain medical conditions or recent significant weight loss may exclude participation. 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. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should be prepared for any costs related to getting to and from study visits.

Actively Recruiting

Phase 3

Age: 12Years - 17Years

All Genders

ID06672939

Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants With Obesity or Overweight With Related Comorbidities

Led by Eli Lilly and Company · Updated on 2026-06-03

150

Participants Needed

Research Sites

161 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of orforglipron, taken once daily by mouth, compared to a placebo in adolescents aged 12 to 17 who have obesity or are overweight with related health issues. This Phase 3 trial aims to evaluate how effective, safe, and how the body processes orforglipron in this group. The study is conducted under a master protocol and sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either orforglipron or a placebo orally. Those who complete the initial study period, including a 4-week safety follow-up, may continue with up to 156 additional weeks of treatment along with ongoing lifestyle interventions. The main treatment and observation period lasts about 18 months. During the study, participants will have their body mass index BMI and other health measures monitored, including body weight, waist size, blood pressure, cholesterol, blood sugar, insulin levels, and body fat through scans. Quality of life related to weight will also be assessed. Researchers will track drug levels in the body and monitor safety throughout. The study includes regular visits and assessments over the full duration to observe changes and effects.

CONDITIONS

Brief Title

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Who Can Participate

Age: 12Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

History of at least one unsuccessful attempt to lose weight with diet and exercise counseling for at least 3 months before screening
Obesity defined as BMI at or above the 95th percentile for age and sex
Overweight defined as BMI between the 85th and 95th percentile with at least one weight-related comorbidity such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, or metabolic liver disease
Age between 12 and 17 years
Ability to participate in study procedures and follow the protocol

You will not qualify if you...

Prepubertal status (Tanner stage 1)
Weight loss greater than 5 kilograms (11 pounds) within 90 days before screening
Undergoing or planning weight reduction surgery during the study (gastric bypass, sleeve gastrectomy, Lap-Band, or other bariatric procedures)
Diagnosis of secondary causes of obesity such as hypothalamic, monogenetic, syndromic, or endocrine causes
Having type 1 diabetes or history of ketoacidosis or hyperosmolar state
HbA1c greater than 9.0% at screening
Personal or family 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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