NCT05696847CompletedPhase 1
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity
Source: ClinicalTrials.gov · Last updated 26 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 17 Jan 2023
- Start date
- 7 Feb 2023
- Primary completion date
- 16 Jan 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT05696847
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 28
- From 7 Feb 2023 to the primary completion date, 16 Jan 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- 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.
Other illness
- 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 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
Who the study is looking for
- 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.
Age in the registry: 6 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta Center of Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Lynn Health Science Institute Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.