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

Lilly

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05696847

I8F-MC-GPHV (Other Identifier)

17370

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 6 patient groups, including a placebo group

Cohort 1: Placebo (BW >=50 kg)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

Cohort 2: Placebo (BW <50 kg)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

Cohort 3: Placebo (BW 40 to 60 kg)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide