A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide<br>Participants will receive tirzepatide subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo<br>Participants will receive placebo. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Body Mass Index (BMI) |  | Baseline, Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | AUC is presented as a single average measure of AUC across the study duration. | Baseline through Week 72 |