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ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT06129539•Debiopharm International SA

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).

Eligibility

Age

5 - 8 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of central precocious puberty.
•2. Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
•3. Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
•4. Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
•5. (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP.
•(b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
•6. (a) Pre-treated participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy.
•(b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
•7. (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy.
•(b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
+2 more criteria

Exclusion Criteria

•1. Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
•2. (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.
•(b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
•3. Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
•4. Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
•5. Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
•6. Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
•7. Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
•8. Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
•9. Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
+1 more criteria

Locations (22)

Rady Children's Hospital - San Diego

San Diego, California, United States

University of California San Francisco-Benioff Children's Hospital

San Francisco, California, United States

Indiana University/Riley Hospital for Children

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Prisma Health Pediatric Endocrinology

Columbia, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Buenos Aires, Argentina

Key Dates

Start Date

July 31, 2024

Primary Completion Date

October 1, 2026

Completion Date

February 1, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Central Precocious Puberty

Interventions

Debio 4326

DRUG

A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

NCT05029622

Central Precocious Puberty

View study

COMPLETED

Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

NCT06720623

Central Precocious Puberty (CPP)

View study

NOT_YET_RECRUITINGPHASE4

Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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