A Phase 3 interventional study of Tirzepatide and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Active, not recruiting at 33 sites in 6 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.
Participants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 160 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.
Have 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, with at least 1 weight-related comorbidity.
Participants with Type 2 Diabetes Mellitus (T2DM)
Exclusion Criteria:
Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Participants will receive placebo.
Drug: Placebo
Administered SC
Also known as: LY3298176
Administered SC
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Percentage of Participants with ≥5% BMI Reduction
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 in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
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 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
Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
AUC is presented as a single average measure of AUC across the study duration.
Time frame: Baseline through 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
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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