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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05696847

Collaborator

(none)

Enrollment

Locations

Arms

20.5

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 11 weeks excluding the screening period.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Tirzepatide Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity

Anticipated Study Start Date :

Feb 7, 2023

Anticipated Primary Completion Date :

Oct 14, 2024

Anticipated Study Completion Date :

Oct 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tirzepatide Tirzepatide administered subcutaneously (SC)	Drug: Tirzepatide Administered SC Other Names: LY3298176
Placebo Comparator: Placebo Placebo administered SC	Drug: Placebo Administered SC

Arm

Intervention/Treatment

Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide

Administered SC

Other Names:

LY3298176

Placebo Comparator: Placebo

Placebo administered SC

Drug: Placebo

Administered SC

Outcome Measures

Primary Outcome Measures

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 11]
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female participants with obesity
Participants with screening body weight ≥ 50 kilogram (kg) for cohort 1 and < 50 kg for cohorts 2 and 3.
Participants with body mass index (BMI) ≥ the 95th percentile for age and sex

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Center of Medical Research	Atlanta	Georgia	United States	30331 2012
2	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05696847

Other Study ID Numbers:

17370
I8F-MC-GPHV

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 15, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Tirzepatide

Study Results

No Results Posted as of Jan 25, 2023