A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Purpose
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.
Conditions
- Obesity
- Overweight
Eligibility
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tirzepatide |
Participants will receive tirzepatide subcutaneously (SC). |
|
|
Placebo Comparator Placebo |
Participants will receive placebo. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company