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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2025-01-16

Brief Summary

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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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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: Placebo (BW >=50 kg)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

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

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.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Cohort 2: Placebo (BW <50 kg)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

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

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.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Cohort 3: Placebo (BW 40 to 60 kg)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

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

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.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No