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GnRH Antagonist

Debio 4326 for Central Precocious Puberty (LIBELULA Trial)

Phase 3

Recruiting

Research Sponsored by Debiopharm International SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Onset of development of sex characteristics before the age of 8 years in girls and 9 years in boys

Diagnosis of central precocious puberty and currently receiving GnRHa therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 64 weeks after the last debio 4326 injection in part a or b

Awards & highlights

LIBELULA Trial Summary

This trial aims to see if Debio 4326 can reduce LH levels to those seen before puberty in children with central precocious puberty who are already receiving GnRHa therapy.

Who is the study for?

This trial is for children diagnosed with central precocious puberty (CPP) who are already on hormone therapy. It's open to kids aged 5-8, and possibly older or younger after an interim review. They should have started puberty early—before age 8 in girls and 9 in boys—and begun treatment within 18 months of these first signs.Check my eligibility

What is being tested?

The study tests Debio 4326's ability to maintain low levels of a puberty-related hormone over a year in kids treated for CPP. The goal is to see if this drug can effectively keep the signs of early puberty under control when used alongside standard hormone therapy.See study design

What are the potential side effects?

While specific side effects aren't listed here, drugs like Debio 4326 could potentially cause reactions at the injection site, hormonal imbalances, mood changes, growth rate alterations, or other endocrine system-related issues.

LIBELULA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I developed early signs of puberty before age 8 (if girl) or 9 (if boy).

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I am being treated for early puberty with hormone therapy.

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I am between 5 and 8 years old.

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My bone age and actual age differ by at least 1 year when I started hormone therapy.

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My hormone test shows a puberty-like response before starting hormone therapy.

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I showed signs of puberty before starting hormone blocker therapy.

LIBELULA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 64 weeks after the last debio 4326 injection in part a or b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~64 weeks after the last debio 4326 injection in part a or b

This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 weeks after the last debio 4326 injection in part a or b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Percentage of Participants With Suppression of Gonadotropin-Releasing Hormone Agonist Stimulated Serum Luteinizing Hormone (LH) to Less Than or Equal to (≤)5 International Units per Liter (IU/L)

Secondary outcome measures

Part B: Accumulation Ratio on Maximum Serum Concentration (RacCmax)

Part B: Accumulation Ratio on Serum Concentration at the End of the Dosing Interval (RacCtrough)

Parts A and B: Change From Baseline in Body Mass Index

+19 more

LIBELULA Trial Design

1Treatment groups

Experimental Treatment

Group I: Debio 4326Experimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Debiopharm International SALead Sponsor

50 Previous Clinical Trials

7,128 Total Patients Enrolled

Study DirectorStudy DirectorDebiopharm International SA

1,211 Previous Clinical Trials

489,219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for participants in this trial, specifically regarding individuals who are above 80 years old?

"Individuals aged above 5 but below 8 are eligible for enrollment in this research study."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this particular medical study is actively enrolling participants. Initially shared on February 1st, 2024, and most recently revised on February 27th, 2024, the trial aims to recruit a total of 53 individuals from two distinct locations."

Answered by AI

What is the current number of individuals receiving medical care as part of this research study?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is actively seeking participants. The trial was initially published on February 1st, 2024 and most recently revised on February 27th, 2024. Approximately 53 individuals are being sought across two designated sites."

Answered by AI

Has the medication Debio 4326 received approval from the FDA?

"Our group at Power has graded the safety of Debio 4326 as a 3 on our scale. This rating is based on the Phase 3 trial status, indicating existing efficacy data and robust safety information from multiple evaluations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty

2024. "A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06129539.

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