Vanderbilt Clinical Trials

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.

Conditions

Obesity
Overweight

Eligibility

Eligible Ages: Between 12 Years and 17 Years
Eligible Genders: 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).	Drug: Tirzepatide Administered SC Other names: LY3298176
Placebo Comparator Placebo	Participants will receive placebo.	Drug: Placebo Administered SC

Recruiting Locations

Vanderbilt Health One Hundred Oaks
Nashville, Tennessee 372212

Contact:
225-226-5662

More Details

Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.