A Phase 3 interventional study of Tirzepatide and Placebo in Obesity, sponsored by Eli Lilly and Company. Recruiting at 82 sites in 10 countries. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 150 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.
J4M-MC-PW02
Have:
J4M-MC-PWMP
Exclusion Criteria:
J4M-MC-PW02
Have a history of
J4M-MC-PWMP
Have undergone or plan to undergo 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.
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.
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 84
Change from Baseline in Body Weight
Time frame: Baseline, Week 84
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 84
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 84
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 84
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 84
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 84
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Time frame: Baseline, Week 84
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Time frame: Baseline, Week 84
Change from Baseline in Height
Time frame: Baseline, Week 84
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Week 84
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Week 84
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Week 84
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)
Time frame: Baseline through Week 84
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 or 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tirzepatide