Obesity, Overweight
Conditions
Brief summary
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.
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
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR * 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. * dyslipidemia * pre-hypertension * hypertension * nonalcoholic fatty liver disease * obstructive sleep apnea * prediabetes * documented preexisting condition of Type 2 Diabetes Participants with Type 2 Diabetes Mellitus (T2DM) * Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%
Exclusion criteria
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records. * Have Type 1 Diabetes * Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction. * Are prepubertal (Tanner stage 1). * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2 * Have a history of chronic or acute pancreatitis. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Mass Index (BMI) | Baseline, Week 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with ≥5% BMI Reduction | Baseline, Week 72 | — |
| Change from Baseline in Body Weight | Baseline, Week 72 | — |
| Change from Baseline in Waist Circumference | Baseline, Week 72 | — |
| Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score | Baseline, Week 72 | — |
| Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts | Baseline, Week 72 | — |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 72 | — |
| Change from Baseline in Diastolic Blood Pressure | Baseline, Week 72 | — |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 72 | — |
| Change from Baseline in Fasting Glucose | Baseline, Week 72 | — |
| Change from Baseline in Fasting Insulin | Baseline, Week 72 | — |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide | Baseline through Week 72 | AUC is presented as a single average measure of AUC across the study duration. |
Countries
Canada, Czechia, Israel, Italy, Poland, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed