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Active Not Recruiting
NCT06075667
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Conditions: Obesity, Overweight
Sex: All
Ages: 12 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 160
Sponsor: Eli Lilly and Company
Location: CenExel iResearch, LLC Decatur Georgia
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.
Eligibility Criteria
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\
Source: ClinicalTrials.gov (NCT06075667). StuddyBuddy aggregates publicly available trial information.