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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30331 2012
      • Recruiting
      • Atlanta Center of Medical Research
      • Contact: Phone Number: 404-881-5800
      • Principal Investigator: R RIESENBERG
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Lynn Health Science Institute
      • Principal Investigator: Carl Griffin
      • Contact: Phone Number: 405-602-3939
  • Texas
    • Houston, Texas, United States, 77030-2600
      • Recruiting
      • Baylor College of Medicine
      • Contact: Phone Number: 713-798-0391
      • Principal Investigator: Stephanie Sisley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 13

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): November 13, 2024
• Study Completion (Estimated): November 13, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Pediatrics; Chronic weight management
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 17370; I8F-MC-GPHV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No