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Completed

NCT Number: NCT05696847

A Study of Tirzepatide (LY3298176) in Pediatric Participants 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atlanta Center of Medical Research, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline through Week 14

    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.

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) 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.

    PK: AUC0-tau of tirzepatide was reported.

  2. PK: Maximum Concentration (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.

    PK: Cmax of tirzepatide

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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