NCT06129539

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

LIBELULA™: An Open-label, Single-arm, Multi-center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric Participants With Central Precocious Puberty

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with central precocious puberty (CPP).

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Debio 4326	Administered as an intramuscular (IM) injection

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-10-01
• Completion: 2028-02-01
• First posted: 2023-11-13
• Last updated: 2026-03-30

Locations

18 sites across 5 countries: United States, Argentina, Brazil, Chile, Mexico

Regulatory

• FDA-regulated drug study