Eli Lilly and Company
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.
Inclusion Criteria: 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…
Administered SC
Administered SC