A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Public ClinicalTrials.gov record NCT06129539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06129539
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Debiopharm International SA
- Industry
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- Debio 4326 Drug
Drug
Eligibility (public fields only)
- Age range
- 5 Years to 8 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2024
- Primary completion
- Sep 30, 2026
- Completion
- Jan 31, 2028
- Last update posted
- Apr 27, 2026
2024 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| University of California San Francisco-Benioff Children's Hospital | San Francisco | California | 94143 | — |
| Prisma Health Pediatric Endocrinology | Columbia | South Carolina | 29203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06129539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2026 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06129539 live on ClinicalTrials.gov.