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NCT05696847 | Recruiting | Obesity

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

Eli Lilly and Company

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.

Condition or disease

Obesity

Intervention/treatment

Tirzepatide

Placebo

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Double
Primary Purpose : Basic Science
Official Title : A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity
Actual Study Start Date : February 7, 2023
Estimated Primary Completion Date : November 13, 2024
Estimated Study Completion Date : November 13, 2024
Arm Intervention/treatment

Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide

Placebo Comparator: Placebo

Placebo administered SC

Drug: Placebo
Ages Eligible for Study: 6 Years to 11 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Georgia

Atlanta Center of Medical Research

Atlanta, Georgia, United States, 30331 2012

Recruiting

United States, Oklahoma

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States, 73112

Recruiting

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030-2600