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

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Lilly

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Drug: Placebo
Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05696847
I8F-MC-GPHV (Other Identifier)
17370

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex
  • Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion
  • Female participants only: Determined as prepubertal Tanner Stage 1.

Exclusion criteria

  • Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
  • Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other GI disorders
  • Have a known clinically significant gastric emptying, have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surger, or have endoscopic or device-based therapy for obesity or have had device removal within the last 6 months.
  • Have confirmed type 1 or type 2 diabetes mellitus
  • Have a history or current cerebrovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IP; or may interfere with the interpretation of data

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups, including a placebo group

Tirzepatide
Experimental group
Description:
Tirzepatide administered subcutaneously (SC)
Treatment:
Drug: Tirzepatide
Placebo
Placebo Comparator group
Description:
Placebo administered SC
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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