RecruitingObesity

Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

Eligible age

6–11 yrs

Accepts

All genders

Locations

23 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 tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ J4M-MC-PW02
✓ Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)
✓ Have:
✓ a body weight of ≥ 40 kilograms (kg) (88 pounds), and
✓ been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
✓ 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 \[CDC-NCHS, 2022\])

You may not qualify if…

✕ J4M-MC-PW02
✕ Have a history of
✕ proliferative diabetic retinopathy
✕ diabetic macular edema, or
✕ nonproliferative diabetic retinopathy that requires acute treatment
✕ J4M-MC-PWMP
✕ Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
✕ gastric bypass