drugset / Trial / NCT06129539

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

NCT06129539 ↗

Phase 3 Active not recruiting 56 enrolled Debiopharm International SA
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2024-07-31
Primary completion
2026-10
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Debio 4326 Unknown — Intramuscular