A Phase 3 interventional study of Tirzepatide and Placebo in Obesity and Weight Gain, sponsored by Eli Lilly and Company. Recruiting at 69 sites in 12 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Participants who have completed the primary 72-week GPIX 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.
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Participants will receive placebo SC.
Drug: Placebo
Administered SC
Also known as: LY3298176
Administered SC
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
Time frame: Baseline, Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
Time frame: Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 72
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
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
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 72
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 72
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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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Jun 2024 (actual). Primary completion is estimated for Oct 2027, 40 months after the start.
Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 40 months is above that.
Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tirzepatide