CPPPhase 4NESTNCT06926933
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
A Phase 4 study testing Eligard® 45 mg in people with CPP, run by HanAll BioPharma Co., Ltd. at 9 sites in South Korea.
Trial summary
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP. Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- CPP
- What is being tested?
- Eligard® 45 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 12 Dec 2024to 30 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation > 5 IU/L
- A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older ~ under 9 years of age) Girl (4 years of age or older ~ under 8 years of age) Tanner Stage : Level 2 or higher
- Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
- Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
- Children with a body weight of more than 20 kg at screening
- Children have a bone age that is ≥1 year older than their chronological age at screening
- A signed written consent form by a legal representative who has been informed about this study
Who cannot join
- Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
- Prior or current GnRH treatment for CPP
- Non-progressing isolated premature thelarche
- Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
- Prior (within 12 weeks of Screening) use of medications
- Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)
Show all 19Show fewer
- Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)
- Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)
- Herbal Medicines
- Prior or current therapy with growth hormone
- Major medical or psychiatric illness that could interfere with study visits
- Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)
- Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women
- Known hypersensitivity to GnRH or related compounds
- Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study
- Any other condition(s) which could significantly interfere with Protocol compliance
- Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0)
- Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
- Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Korea University Ansan Hospital
Ansan
Jeonbuk National University Hospital
Jeonju
Chosun University Hospital
Kwangju
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
Kyung Hee University Hospital At Gangdong
Seoul
Ajou University Medical Center
Suwon
About this study
Official title: An Open Label, Single-group, Multicenter Study on the Efficacy and Safety of Leuprolide Acetate 45 mg for Injectable Suspension-controlled Release in Subjects With Central (Gonadotropin-dependent) Precocious Puberty
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.
Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.
- Conditions
- CPP
- Being tested
- Eligard® 45 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligard® 45 mgDrug
45 mg of leuprolide acetate
| Study group | Role | What they receive |
|---|---|---|
| Eligard® 45 mg | Experimental | SC injection of study drug (45 mg of leuprolide acetate for injectable suspensions) Receives: Drug: Eligard® 45 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test
Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory.
Measured: at week 24
Secondary outcomes (5)
The percentage (%) of subjects with suppressed serum LH concentrations (< 4 IU/L) 30-minutes post GnRH stimulation test
Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory.
Measured: at week 12, 48, 72, 96
The percentage (%) of subjects with suppressed serum FSH (< 2.5 mIU/mL), estradiol (< 20 pg/mL, for girl) or testosterone (< 30 ng/dL, for boy)
Sexual development in puberty will be assessed by Tanner staging
Measured: at week 12, 24, 48, 72, 96
The percentage of subject of Tanner stage (including menstruation)
Sexual development in puberty will be assessed by Tanner staging
Measured: at week 12, 24, 48, 72, 96
Height velocity (growth rate)
Annualized Height Velocity
Measured: at week 12, 24, 48, 72, 96
The ratio of bone age and chronological age
A single X-ray of the non-dominant hand and wrist will be obtained periodically
Measured: at week 12, 24, 48, 72, 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start12 Dec 2024
- Primary completion15 Jun 2026
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eunhee Lee, Study director, Hanall Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926933
- Sponsor's protocol ID
- HLA24IV_1
- Acronym
- NEST
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-group, Multicenter Study on the Efficacy and Safety of Leuprolide Acetate 45 mg for Injectable Suspension-controlled Release in Subjects With Central (Gonadotropin-dependent) Precocious Puberty
- ClinicalTrials.gov ID
- NCT06926933
- Acronym / sponsor ID
- NEST / HLA24IV_1
- Conditions
- CPP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.
Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligard® 45 mg | Experimental | Drug: Eligard® 45 mgSC injection of study drug (45 mg of leuprolide acetate for injectable suspensions) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation > 5 IU/L
- A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older ~ under 9 years of age) Girl (4 years of age or older ~ under 8 years of age) Tanner Stage : Level 2 or higher
- Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
- Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
- Children with a body weight of more than 20 kg at screening
Key exclusion criteria (19 listed)
- Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
- Prior or current GnRH treatment for CPP
- Non-progressing isolated premature thelarche
- Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
- Prior (within 12 weeks of Screening) use of medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eligard® 45 mg45 mg of leuprolide acetate | Drug | Eligard® 45 mg |
Primary outcome
The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test
Time frame: at week 24
Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory.
5 secondary outcomes
The percentage (%) of subjects with suppressed serum LH concentrations (< 4 IU/L) 30-minutes post GnRH stimulation test
Time frame: at week 12, 48, 72, 96
The percentage (%) of subjects with suppressed serum FSH (< 2.5 mIU/mL), estradiol (< 20 pg/mL, for girl) or testosterone (< 30 ng/dL, for boy)
Time frame: at week 12, 24, 48, 72, 96
The percentage of subject of Tanner stage (including menstruation)
Time frame: at week 12, 24, 48, 72, 96
Height velocity (growth rate)
Time frame: at week 12, 24, 48, 72, 96
The ratio of bone age and chronological age
Time frame: at week 12, 24, 48, 72, 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunhee Lee study director
Hanall Biopharma
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eligard® 45 mg in people with CPP, run by HanAll BioPharma Co., Ltd. at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test (time frame: at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.