A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
- Registration Number
- NCT06075667
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
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
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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%
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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.
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Have Type 1 Diabetes
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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.
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Are prepubertal (Tanner stage 1).
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Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
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Have a history of chronic or acute pancreatitis.
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo. Tirzepatide Tirzepatide Participants will receive tirzepatide subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Mass Index (BMI) Baseline, Week 72
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (33)
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Barry J. Reiner, MD, LLC
🇺🇸Baltimore, Maryland, United States
M Health Fairview - Delaware Clinical Research Unit (DCRU)
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
PriMED Clinical Research
🇺🇸Dayton, Ohio, United States
Vanderbilt Health One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
Scroll for more (23 remaining)CenExel iResearch, LLC🇺🇸Decatur, Georgia, United States