RecruitingObesityOverweight

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

Eligible age

12–17 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ J4M-MC-PWMP
✓ Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
✓ Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR
✓ 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,
✓ hypertension
✓ type 2 diabetes (T2D)
✓ prediabetes
✓ dyslipidemia

You may not qualify if…

✕ J4M-MC-PW01
✕ Prepubertal (Tanner stage 1)
✕ Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening
✕ J4M-MC-PWMP
✕ Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
✕ gastric bypass
✕ sleeve gastrectomy
✕ restrictive bariatric surgery, such as Lap-Band® gastric banding, or