Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT06129539 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Debio 4326

Study Locations (20)

Other

  • Instituto de Investigaciones Metabolicas (IDIM) — Buenos Aires
  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada — Buenos Aires
  • Centro de Investigaciones Medicas Mar del Plata — Mar del Plata
  • Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L — San Miguel de Tucumán
  • Hospital Da Criança de Brasília Jose Alencar — Brasília
  • Hospital Universitario Walter Cantidio — Fortaleza
  • Clínica de Endocrinologia e Metabologia Ltda — Lago Sul
  • Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS — Porto Alegre
  • CPQuali Pesquisa Clinica — São Paulo
  • Irmandade Santa Casa de São Paulo — São Paulo
  • Integral Pesquisa e Ensino — Votuporanga
  • ENDOMET — Antofagasta

California

  • Rady Children's Hospital - San Diego — San Diego
  • University of California San Francisco-Benioff Children's Hospital — San Francisco

Texas

  • University of Texas Southwestern Medical Center — Dallas
  • Texas Children's Hospital — Houston

Indiana

  • Indiana University/Riley Hospital for Children — Indianapolis

Missouri

  • Washington University — St Louis

South Carolina

  • Prisma Health Pediatric Endocrinology — Columbia

Virginia

  • Virginia Commonwealth University Health System — Richmond

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2024-07-31
Est. Completion 2028-02
Phase Phase 3

Sponsor

Debiopharm International

41 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06129539

The ClinicalTrials.gov registry entry for NCT06129539 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Central Precocious Puberty appearing as the primary indexed condition, and to 1 intervention — of which Debio 4326 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06129539 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06129539 about?

NCT06129539 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)". 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).

What is the current status of trial NCT06129539?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2024-07-31. Estimated completion is 2028-02.

What conditions does trial NCT06129539 study?

This clinical trial studies the following conditions: Central Precocious Puberty. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06129539?

The interventions under investigation include: Debio 4326 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06129539?

This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06129539 being conducted?

This trial has 20 study locations across California, Indiana, Missouri, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial