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

NCT06129539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-28

No results posted yet for this study

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

DRUG

Debio 4326

Administered as an intramuscular (IM) injection

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Study Director · Debiopharm International SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-10-31
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06129539 on ClinicalTrials.gov