Study of Orforglipron vs Placebo for Treating Obesity or Overweight with Related Health Issues in Adolescents Aged 12 to 17

What this Trial Is About

Researchers are evaluating the effects of orforglipron, taken once daily by mouth, compared to placebo in adolescents aged 12 to 17 years who have obesity or are overweight with related health conditions. The study aims to assess the drugs efficacy, safety, and how it is processed by the body. This phase 3 trial 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 once daily. Those who complete the initial PW01 study, including a safety follow-up period, may continue receiving orforglipron for an additional 156 weeks while maintaining lifestyle interventions such as diet and exercise counseling. The trial follows a double-blind design where neither participants nor researchers know the assigned treatment. During the roughly 18-month participation, adolescents will undergo regular assessments including body mass index BMI, body weight, waist circumference, blood pressure, cholesterol, glucose levels, insulin levels, body fat mass via DXA scans, and quality of life related to weight impact. Pharmacokinetic measurements will also be taken to study the drugs concentration over time. Safety and effectiveness will be monitored through these evaluations at baseline and at Week 72.

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