Phase 1
Completed N=28
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
Obesity
Source: ClinicalTrials.gov NCT05696847 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) — 0.0; 83.3; 0.0; 85.7 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) |
0.0; 83.3; 0.0; 85.7; 33.3; 100.0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide |
105000; 80800; 156000 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Tirzepatide |
884; 674; 1280 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05696847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.