A Phase 3 interventional study of Debio 4326 in Central Precocious Puberty, sponsored by Debiopharm International SA. Active, not recruiting at 17 sites in 5 countries. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Debiopharm International SA (part of Debiopharm) · Phase 3, Interventional, and Treatment
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).
75 studies on the registry are indexed under Puberty, Precocious; 18 are open to participants now.
This study's enrollment of 56 is below the median of 64 across 47 interventional studies indexed under Puberty, Precocious.
Browse Puberty, Precocious studies →Debiopharm International SA is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(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.
(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.
(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.
(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:
(a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.
(b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Debio 4326
Administered as an intramuscular (IM) injection
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)
Time frame: Week 52 in Part A
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Serious TEAEs
Time frame: Up to 104 weeks
Parts A and B: Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: Up to 104 weeks
Parts A and B: Change From Baseline in Body Weight
Time frame: Up to 104 weeks
Parts A and B: Change From Baseline in Body Mass Index
Time frame: Up to 104 weeks
Parts A and B: Number of Participants With Erythema, Swelling, and Induration at the Injection Site Immediately and 2 Hours After Each Debio 4326 Injection as per Investigator's Assessment
Time frame: Up to 2 hours post-dose on Day 1 in both Parts A and B
Parts A and B: Number of Participants With Pain at the Injection Site Immediately and 2 Hours After Each Debio 4326 Injection as per Participant's Assessment Using the Wong-Baker FACES® Pain Rating Scale
Time frame: Up to 2 hours post-dose on Day 1 in both Parts A and B
Parts A and B: Percentage of Participants Who do not Exhibit the Acute-on-Chronic (AOC) Phenomenon
Time frame: Up to 48 hours post-dose on Day 3 in both Parts A and B
Parts A and B: Percentage of Participants With Stimulated Serum LH ≤5 IU/L
Time frame: Up to Week 52 in both Parts A and B
Parts A and B: Percentage of Participants With Stimulated Serum LH ≤4 IU/L
Time frame: Up to Week 52 in both Parts A and B
Parts A and B: Number of Participants With Change in Hormone Levels
The following hormones will be assessed: basal LH, follicle-stimulating hormone (FSH), estradiol, testosterone, GnRHa-stimulated LH, and GnRHa-stimulated FSH.
Time frame: Up to Week 52 in both Parts A and B
Parts A and B: Percentage of Girls With Prepubertal Serum Estradiol <20 pg/mL (<73 pmol/L)
Time frame: Up to Week 52 in both Parts A and B
Parts A and B: Percentage of Boys With Testosterone <30 ng/dL (<1.0 nmol/L)
Time frame: Up to Week 52 in both Parts A and B
Parts A and B: Change From Baseline in Height-for-Age Z Score
Time frame: Baseline, up to Week 52 in both Parts A and B
Parts A and B: Number of Participants With Change From Baseline in Growth Velocity
Time frame: Up to Week 52 in both Parts A and B
Percentage of Participants in Whom the Bone Age/Chronological Age Did Not Rise Relative to Baseline
Time frame: Part A: Baseline, up to Week 52 in both Parts A and B
Parts A and B: Percentage of Participants Who Achieve Stabilization of Sexual Maturation (Regression or Stabilization Compared to Baseline by Tanner Staging)
Time frame: Baseline, Weeks 26 and 52 in both Parts A and B
Parts A and B: Percentage of Girls With Regression of Uterine Length (Using Transabdominal Ultrasound)
Time frame: Weeks 26 and 52 in both Parts A and B
Parts A and B: Percentage of Boys With Absence of Progression of Testis Volumes (Clinical Assessment With Orchidometer)
Time frame: Weeks 26 and 52 in both Parts A and B
Parts A and B: Plasma Concentration of Triptorelin
The pharmacokinetics (PK) of triptorelin will be evaluated in plasma.
Time frame: Pre-dose and at multiple timepoints post-dose up to 52 weeks in Part A and 64 weeks in Part B
Percentage of Participants With Stimulated Serum LH Levels Greater Than (>)5 IU/L at Post Treatment Visit (PTV)
This outcome measure will be analyzed only in participants who stop all hormonal treatment with any GnRHa at end of treatment (EOT).
Time frame: 64 weeks after the last Debio 4326 injection in Part A or B
Part B: Accumulation Ratio on Maximum Serum Concentration (RacCmax)
Time frame: At multiple timepoints post-dose up to 48 hours (Day 2) in Part B
Part B: Accumulation Ratio on Serum Concentration at the End of the Dosing Interval (RacCtrough)
Time frame: At multiple timepoints post-dose up to 52 weeks in Part B
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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