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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696847
• Other study ID #: 17370
• Secondary ID: I8F-MC-GPHV
• Status: Recruiting
• Phase: Phase 1
• Start date: February 7, 2023
• Est. completion date: November 13, 2024

Study information

• Verified date: October 1, 2023
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 13, 2024
• Est. primary completion date: November 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	Baylor College of Medicine	Houston	Texas
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PK: Maximum Concentration (Cmax) of Tirzepatide	PK: Cmax of tirzepatide	Predose up to 168 hours postdose