Obesity, Weight Gain
Conditions
Brief summary
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.
Detailed description
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.
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 body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. * Have history of at least 1 self-reported unsuccessful dietary effort to lose weight. * Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
Exclusion criteria
* Have undergone or plan to undergo a 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 self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state * Have type 2 diabetes or have a HbA1c \> 6.4% at screening * Have a history of chronic or acute pancreatitis * 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 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 | Baseline, Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieve BMI Reduction of ≥ 5% | Week 72 |
| Percentage of Participants Who Achieve BMI Reduction of ≥ 10% | Week 72 |
| Percentage of Participants Who Achieve BMI Reduction of ≥ 15% | Week 72 |
| Percentage of Participants Who Achieve BMI Reduction of ≥ 20% | Week 72 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 72 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 72 |
| Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI) | Baseline, Week 72 |
| Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA) | Baseline, Week 72 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 72 |
| Percent Change from Baseline in Body Weight | Baseline, Week 72 |
| Change from Baseline in Waist Circumference | Baseline, Week 72 |
Countries
Argentina, Australia, Canada, France, Germany, Israel, Mexico, Puerto Rico, Spain, Taiwan, United Kingdom, 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