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Evaluating Debio 4326 for treating central precocious puberty in children

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

Phase 3 Interventional Debiopharm International SA · NCT06129539

This study is testing a new treatment called Debio 4326 to see if it can help children aged 5 to 8 with early signs of puberty by lowering their hormone levels back to normal.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment56 (estimated)
Ages5 Years to 8 Years
SexAll
SponsorDebiopharm International SA Industry-sponsored
Locations43 sites (Tucson, Arizona and 42 other locations)
Trial IDNCT06129539 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy, safety, and pharmacokinetics of Debio 4326 in pediatric participants diagnosed with central precocious puberty (CPP). The primary goal is to determine whether Debio 4326 can effectively suppress serum luteinizing hormone (LH) levels to prepubertal levels over a 52-week period following the first injection. Participants will include children aged 5 to 8 years who have shown early signs of puberty, with the possibility of including younger and older children based on interim analysis. The study will involve administering Debio 4326 and monitoring its effects on hormone levels and overall safety.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5 to 8 years who have been diagnosed with central precocious puberty and have shown early signs of sexual development.

Not a fit: Patients who are older than 10 years or younger than 2 years, or those who do not have a diagnosis of central precocious puberty, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing central precocious puberty in children.

How similar studies have performed: Other studies have shown promise in treating central precocious puberty with hormonal therapies, but the specific approach of using Debio 4326 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
8. (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy.

   (b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.

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.
10. Use of anticoagulants (heparin or coumarin derivatives).

Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Where this trial is running

Tucson, Arizona and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Central Precocious Puberty
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.