Suspended

LIBELULADebio 4326 for LH Suppression in Pediatric Central Precocious Puberty

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Study Aim

This study aims to evaluate the effectiveness of Debio 4326 in suppressing Luteinizing Hormone (LH) in children with Central Precocious Puberty, by measuring the percentage of participants with LH levels less than or equal to 5 International Units per Liter (IU/L) after treatment.

What is being tested

Debio 4326

Drug
Who is being recruted

Endocrine System Diseases

+ Gonadal Disorders

+ Puberty, Precocious

From 5 to 8 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorDebiopharm International SA
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 31, 2024

Actual date on which the first participant was enrolled.

The study focuses on evaluating a new medication called Debio 4326, which is designed to manage a condition known as central precocious puberty (CPP) in children. CPP is when puberty starts too early in children, and this can lead to various health and emotional issues. The goal is to see how well Debio 4326 can reduce certain hormone levels to those expected in prepubertal children, essentially slowing down the early onset of puberty. This is important because managing CPP effectively can help children develop more typically both physically and emotionally. Participants in this study will receive an injection of Debio 4326, which is a formulation of the drug Triptorelin designed to last for 12 months. Throughout the study, researchers will monitor the participants to see if their hormone levels, specifically the luteinizing hormone (LH), are lowered to levels typical of those in pre-puberty over a period of 52 weeks. The study will also keep track of any side effects or safety concerns related to the treatment, ensuring that it is not only effective but also safe for use in young children with CPP.

Official TitleLIBELULA™: 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
Principal SponsorDebiopharm International SA
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesGonadal DisordersPuberty, Precocious

Criteria

7 inclusion criteria required to participate
Diagnosis of central precocious puberty.
Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
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.
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.
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11 exclusion criteria prevent from participating
Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 31 locations

Suspended

TMC HealthCare

Tucson, United StatesOpen TMC HealthCare in Google Maps
Suspended

Rady Children's Hospital - San Diego

San Diego, United States
Suspended

University of California San Francisco-Benioff Children's Hospital

San Francisco, United States
Suspended

Wolfson's Children's Hospital

Jacksonville, United States
Suspended31 Study Centers