Obesity
Conditions
Keywords
Pediatric, Children
Brief summary
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.
Interventions
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\])
Exclusion criteria
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 * sleeve gastrectomy * restrictive bariatric surgery, such as Lap-Band® gastric banding, or * any other procedure intended to result in weight reduction. * Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Mass Index (BMI) | Baseline, Week 84 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Body Weight | Baseline, Week 84 |
| Change from Baseline in Waist Circumference | Baseline, Week 84 |
| Change from Baseline in Blood Pressure | Baseline, Week 84 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 84 |
| Change from Baseline in Fasting Glucose | Baseline, Week 84 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 84 |
| Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score | Baseline, Week 84 |
| Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score | Baseline, Week 84 |
| Change from Baseline in Height | Baseline, Week 84 |
| Change from Baseline in Alanine Aminotransferase (ALT) | Baseline, Week 84 |
| Change from Baseline in Aspartate Aminotransferase (AST) | Baseline, Week 84 |
| Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Week 84 |
| Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css) | Baseline through Week 84 |
Countries
Belgium, Israel, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed