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

Phase 1

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Cohort 1: Placebo (BW >=50 kg)	Placebo	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.
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	Tirzepatide	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.
Cohort 2: Placebo (BW <50 kg)	Placebo	Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	Tirzepatide	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.
Cohort 3: Placebo (BW 40 to 60 kg)	Placebo	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.
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)	Tirzepatide	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)	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 Outcome Measures

Name	Time	Method
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: AUC0-tau of tirzepatide was reported.
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.	PK: Cmax of tirzepatide

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