Status:
ACTIVE_NOT_RECRUITING
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06075667
Start Date
October 16 2023
End Date
July 1 2029
Last Update
June 25 2025
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
2
Solaris Clinical Research
Meridian, Idaho, United States, 83646
3
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States, 66606
4
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808