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

Eli Lilly and Company28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

TirzepatideDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.

Time frame: Baseline through Week 14

Secondary Outcomes

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 was reported.

Time frame: Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

PK: Maximum Concentration (Cmax) of Tirzepatide

PK: Cmax of tirzepatide

Time frame: Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

Data from ClinicalTrials.gov

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