A Phase 3 interventional study of Orforglipron and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Recruiting at 34 sites in 6 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.
Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 150 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
J4M-MC-PWMP
Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
Exclusion Criteria:
J4M-MC-PW01
J4M-MC-PWMP
Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Administered orally
Also known as: LY3502970
Administered orally
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Change from Baseline in BMI
Time frame: Baseline, Week 72
Change from Baseline in Body Weight
Time frame: Baseline, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 72
Change from Baseline in Body Weight Percentile
Based on sex- and age-specific growth charts
Time frame: Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores
The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains: * physical comfort (6 items) * body esteem (9 items) * social life (6 items), and * family relations (6 items). It has a recall period of "the past 7 days." All items are rated on a 5-point truth scale ("always true" to "never true"). The 4-domain scores and total score range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 72
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 72
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron
Time frame: Baseline, Week 72
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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