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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT05696847
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-25
• Study Start: 2023-02-07
• Primary Completion: 2025-01-16
• Study Completion: 2025-01-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Tirzepatide administered subcutaneously (SC)
Placebo	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Week 13	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide	Predose up to 168 hours postdose	PK: AUC0-tau of tirzepatide
PK: Maximum Concentration (Cmax) of Tirzepatide	Predose up to 168 hours postdose	PK: Cmax of tirzepatide

Trial Locations

Locations (3)

Atlanta Center of Medical Research; 🇺🇸 Atlanta, Georgia, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States