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

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Eli Lilly and Company
Study ID
NCT06075667
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants will receive tirzepatide subcutaneously (SC).
  • Placebo Comparator: Placebo
    Participants will receive placebo.

Primary Outcome Measure

Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]

Locations (10)

FacilityCityStateZIPSite coordinators
CenExel iResearch, LLCDecaturGeorgia30030-
Solaris Clinical ResearchMeridianIdaho83646-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Barry J. Reiner, MD, LLCBaltimoreMaryland21229-
M Health Fairview - Delaware Clinical Research Unit (DCRU)MinneapolisMinnesota55414-
Washington University School of MedicineSt LouisMissouri63110-
Aventiv Research IncColumbusOhio43213-
PriMED Clinical ResearchDaytonOhio45429-
Vanderbilt Health One Hundred OaksNashvilleTennessee372212-

Find similar trials in Decatur, GA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
CenExel iResearch, LLC· Decatur, GASolaris Clinical Research· Meridian, IDCotton O'Neil Diabetes & Endocrinology· Topeka, KSPennington Biomedical Research Center· Baton Rouge, LABarry J. Reiner, MD, LLC· Baltimore, MDM Health Fairview - Delaware Clinical Research Unit (DCRU)· Minneapolis, MN

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