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

NCT05696847 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17370I8F-MC-GPHV
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity

Keywords

Pediatrics; Obesity; Chronic weight management

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through Week 14

Secondary Outcomes (2)

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

  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

  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.

Study Arms (6)

Cohort 1: Placebo (BW >=50 kg)

PLACEBO COMPARATOR

Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.

Drug: Placebo

Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)

EXPERIMENTAL

Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

Drug: Tirzepatide

Cohort 2: Placebo (BW <50 kg)

PLACEBO COMPARATOR

Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.

Drug: Placebo

Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)

EXPERIMENTAL

Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.

Drug: Tirzepatide

Cohort 3: Placebo (BW 40 to 60 kg)

PLACEBO COMPARATOR

Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.

Drug: Placebo

Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)

EXPERIMENTAL

Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg); Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg); Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)

Placebo DRUG

Administered SC

Cohort 1: Placebo (BW >=50 kg); Cohort 2: Placebo (BW <50 kg); Cohort 3: Placebo (BW 40 to 60 kg)

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Atlanta Center of Medical Research

Atlanta, Georgia, 30331 2012, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 25, 2023
• Study Start: February 7, 2023
• Primary Completion: January 16, 2025
• Study Completion: January 16, 2025
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)