A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Eli Lilly and Company
Study ID
NCT05696847
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 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 tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. The blood tests will be performed to investigate how the body processes the study drug in these participants. For each participant, the study will last about approximately 13 weeks excluding the screening period.

Key Dates

Start date
Feb 7, 2023
Status verified
Aug 2025
Primary completion
Jan 16, 2025
Completion
Jan 16, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Cohort 1: Placebo (BW >=50 kg)
    Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
  • Experimental: Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
  • Placebo Comparator: Cohort 2: Placebo (BW <50 kg)
    Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
  • Experimental: Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
  • Placebo Comparator: Cohort 3: Placebo (BW 40 to 60 kg)
    Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
  • Experimental: Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

Primary Outcome Measure

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline through Week 14 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Atlanta Center of Medical ResearchAtlantaGeorgia30331 2012-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Baylor College of MedicineHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Atlanta Center of Medical Research· Atlanta, GALynn Health Science Institute· Oklahoma City, OKBaylor College of Medicine· Houston, TX

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