Trial results for a Phase 1 study (NCT05696847) investigating tirzepatide in pediatric participants with obesity were posted on ClinicalTrials.gov on 2025-08-26. The study, primarily evaluating safety and tolerability, reported treatment-emergent adverse events (TEAEs) in 83.3% to 100.0% of tirzepatide-treated participants across different cohorts, while no serious adverse events (SAEs) occurred in any group.
Background
The study aimed to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. It also investigated how the body processes the study drug in these participants.
Trial design
The study (NCT05696847) was a Phase 1, completed trial that enrolled 28 participants. The study investigated tirzepatide in pediatric participants with obesity. Participants were assigned to receive either tirzepatide at various doses (1.25-2.5 mg or 2.5-5 mg) or placebo. The main purpose was to evaluate the safety and tolerability of tirzepatide and to investigate how the body processes the study drug in these participants. The study lasted approximately 13 weeks, excluding the screening period.
Key results
The trial evaluated the "Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)".
For Treatment Emergent Adverse Events (TEAEs):
- In Cohort 1 (Body Weight >=50 kg), 0.0% of participants in the placebo group experienced TEAEs, compared to 83.3% in the 2.5-5 mg Tirzepatide group.
- In Cohort 2 (Body Weight <50 kg), 0.0% of participants in the placebo group experienced TEAEs, compared to 85.7% in the 1.25-2.5 mg Tirzepatide group.
- In Cohort 3 (Body Weight 40 to 60 kg), 33.3% of participants in the placebo group experienced TEAEs, compared to 100.0% in the 2.5-5 mg Tirzepatide group.
For Serious Adverse Events (SAEs):
- Across all cohorts and treatment arms (placebo, 1.25-2.5 mg Tirzepatide, and 2.5-5 mg Tirzepatide), 0.0% of participants experienced Serious Adverse Events.
What this means
The results from this Phase 1 study indicate that tirzepatide in pediatric participants with obesity is associated with a high incidence of treatment-emergent adverse events across the tested dose ranges. While a significant proportion of participants receiving tirzepatide experienced TEAEs (ranging from 83.3% to 100.0%), it is notable that no serious adverse events were reported in any treatment or placebo group. These findings provide initial safety and tolerability data for tirzepatide in this specific pediatric population, which is crucial for informing further clinical development.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05696847, titled "A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity," were posted on 2025-08-26 on clinicaltrials.gov.