Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 1 change
notable Trial sites reduced: 22 -> 18 locations 2026-03-31
Trial Details
NCT Number NCT06129539
Lead Sponsor Debiopharm International SA
Conditions Central Precocious Puberty
Enrollment 56 participants
Start Date 2024-07-31
Primary Completion 2026-10 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-27