Turner SyndromePhase 3NCT07221851
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
A Phase 3 study testing Lonapegsomatropin [SKYTROFA®] and Somatropin Pen Injector in people with Turner Syndrome and Short Stature Homeobox Gene Mutation, run by Ascendis Pharma A/S at 56 sites in 7 countries.
Trial summary
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature
- What is being tested?
- Lonapegsomatropin [SKYTROFA®] and Somatropin Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 56 sitesin 7 countries
- Study dates
- 12 Dec 2025to Mar 2029
- Phase
- Phase 3
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronological age between ≥2 and <18 years, at start of screening.
- Naïve to growth hormone and growth hormone promoting therapies.
- Prepubertal.
- Able to stand without assistance.
- Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:
- TS or SHOX-D (Léri-Weill dyschondrosteosis):
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- Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.
- Impaired growth or short stature defined as:
- (i.) AHV <25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height <5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States
- SGA without catch-up growth:
- Birth weight and/or birth length < -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used.
- Impaired growth or short stature defined as: (i.) AHV <25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height < -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height < -2.5 SDS for age and sex according to the for children ≥ 2 years and < 3 years
- ISS:
- Height < -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature.
- Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS >0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.
- If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.
- Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB/HREC/IEC.
Who cannot join
- Advanced bone age X-ray by central reading defined as >20% above chronological age in months (Greulich 1959).
- Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.
- Current clinical diagnosis of diabetic retinopathy
- Any diagnosis or presence at screening of the following:
- Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.
- Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.
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- Signs/symptoms of intracranial hypertension, active proliferative retinopathy.
- Uncontrolled hypo- or hyperthyroidism.
- Uncontrolled diabetes mellitus (defined as: HbA1c >7.5% from central laboratory at screening).
- Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and/or cardio-thoracic surgery due to their independent effects on growth.
- Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR <60 mL/min/1.73m2).
- Undiagnosed or uncontrolled hypertension.
- Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit/hyperactivity disorder (ADHD).
- High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.
- Female who is pregnant, plans to be pregnant, or breastfeeding.
- Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.
- Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.
- Exclusion Criteria only applicable to TS:
- Presence of Y chromosome material on genetic testing without history of gonadectomy.
- Less than 10% of 45,X mosaicism.
- Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.
- Exclusion Criteria only applicable to SGA:
- Any known clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements: (i.)Chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors.
- (ii.)Congenital abnormalities (causing skeletal abnormalities), including but not limited to skeletal dysplasias.
- Exclusion Criteria only applicable to ISS:
- Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.
Trial locations and contacts
56 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
56 sites in 7 countries
United States27 sites, 27 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Atlanta, Georgia, 30329
- Recruiting
Ascendis Pharma Investigational Site
Aurora, Colorado, 80045
- Recruiting
Ascendis Pharma Investigational Site
Boston, Massachusetts, 02115
- Recruiting
Ascendis Pharma Investigational Site
Centennial, Colorado, 80112
- Recruiting
Ascendis Pharma Investigational Site
Chapel Hill, North Carolina, 27599
- Recruiting
Ascendis Pharma Investigational Site
Charlottesville, Virginia, 22908
- Recruiting
Ascendis Pharma Investigational Site
Cincinnati, Ohio, 45229
- Recruiting
Ascendis Pharma Investigational Site
Columbia, South Carolina, 29203
- Recruiting
Ascendis Pharma Investigational Site
Edinburg, Texas, 78539
- Recruiting
Ascendis Pharma Investigational Site
Fort Worth, Texas, 76104
- Recruiting
Ascendis Pharma Investigational Site
Idaho Falls, Idaho, 83404
- Recruiting
Ascendis Pharma Investigational Site
Lake Success, New York, 11042
- Recruiting
Ascendis Pharma Investigational Site
Minneapolis, Minnesota, 55454
- Recruiting
Ascendis Pharma Investigational Site
New Orleans, Louisiana, 70118
- Recruiting
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Ascendis Pharma Investigational Site
Orlando, Florida, 32806
- Recruiting
Ascendis Pharma Investigational Site
Palo Alto, California, 94304
- Recruiting
Ascendis Pharma Investigational Site
Phoenix, Arizona, 85016
- Recruiting
Ascendis Pharma Investigational Site
Sacramento, California, 95821
- Recruiting
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, 55102
- Recruiting
Ascendis Pharma Investigational Site
Salt Lake City, Utah, 84112
- Recruiting
Ascendis Pharma Investigational Site
San Antonio, Texas, 78229
- Recruiting
Ascendis Pharma Investigational Site
San Antonio, Texas, 78232
- Recruiting
Ascendis Pharma Investigational Site
Seattle, Washington, 98105
- Recruiting
Ascendis Pharma Investigational Site
St. Petersburg, Florida, 33701
- Recruiting
Ascendis Pharma Investigational Site
Washington D.C., District of Columbia, 20010
- Recruiting
Ascendis Pharma Investigational Site
Wilmington, Delaware, 19803
South Korea7 sites, 7 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Sejong, 30099
- Recruiting
Ascendis Pharma Investigational Site
Seongnam, 13620
- Recruiting
Ascendis Pharma Investigational Site
Seoul, 03722
- Recruiting
Ascendis Pharma Investigational Site
Seoul, 05278
- Recruiting
Ascendis Pharma Investigational Site
Seoul, 05505
- Recruiting
Ascendis Pharma Investigational Site
Seoul, 06273
- Recruiting
Ascendis Pharma Investigational Site
Suwon, 16499
Spain6 sites, 6 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Barcelona, 08035
- Recruiting
Ascendis Pharma Investigational Site
Barcelona, 8950
- Recruiting
Ascendis Pharma Investigational Site
Madrid, 28046
- Recruiting
Ascendis Pharma Investigational Site
Málaga, 29011
- Recruiting
Ascendis Pharma Investigational Site
Santiago de Compostela, 15706
- Recruiting
Ascendis Pharma Investigational Site
Zaragoza, 50009
France5 sites, 5 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Angers, 49933
- Recruiting
Ascendis PharmaInvestigational Site
Le Kremlin-Bicêtre, 94270
- Recruiting
Ascendis Pharma Investigational Site
Montpellier, 34090
- Recruiting
Ascendis Pharma Investigational Site
Paris, 75012
- Recruiting
Ascendis Pharma Investigational Site
Toulouse, 31300
Italy5 sites, 5 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Florence, 50139
- Recruiting
Ascendis Pharma Investigational Site
Genova, 16147
- Recruiting
Ascendis Pharma Investigational Site
Naples, 80131
- Recruiting
Ascendis Pharma Investigational Site
Naples, 80138
- Recruiting
Ascendis Pharma Investigational Site
Trieste, 34123
Germany4 sites, 4 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Cologne, 50931
- Recruiting
Ascendis Pharma Investigational Site
Düsseldorf, 40225
- Recruiting
Ascendis Pharma Investigational Site
Hanover, 30173
- Recruiting
Ascendis Pharma Investigational Site
Tübingen, 72076
Romania2 sites, 2 recruiting
- Recruiting
Ascendis Pharma Investigational Site
Iași, 700106
- Recruiting
Ascendis Pharma Investigational Site
Târgu Mureş, 540136
About this study
Official title: A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Being tested
- Lonapegsomatropin [SKYTROFA®], Somatropin Pen Injector
- Keywords
- Turner Syndrome, Noonan Syndrome, Growth Hormone, Short Stature, Growth Failure, Sex Chromosome Disorders, Chromosome Disorders, Endocrine System Diseases, Pituitary Hormones, Anterior, Pituitary Hormones, Hormones, Hormone Substitutes, Human Growth Hormone, Lonapegsomatropin, Sex Chromosome Disorders of Sex Development, Impaired Growth, somatropin, Growth Hormone Sufficiency, Short Stature Homeobox Gene Mutation, Short Stature Children Born Small for Gestational Age
- Medical subject headings
- Turner Syndrome, Noonan Syndrome, Dwarfism, Failure to Thrive, Sex Chromosome Disorders, Chromosome Disorders, Endocrine System Diseases, Sex Chromosome Disorders of Sex Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lonapegsomatropin [SKYTROFA®]Combination product
Subcutaneous injection once weekly
Somatropin Pen InjectorCombination product
Subcutaneous injection once daily
| Study group | Role | What they receive |
|---|---|---|
| Lonapegsomatropin, once daily | Experimental | Participants will receive Lonapegsomatropin by subcutaneous injection for 2 years (104 weeks) Receives: Combination Product: Lonapegsomatropin [SKYTROFA®] |
| somatropin, once daily | Active comparator | Participants will receive somatropin by subcutaneous injection for 1 year (52 weeks) followed by lonapegsomatropin for 1 year (52 weeks) Receives: Combination Product: Somatropin Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Height Velocity (AHV) (cm/year)
To evaluate the efficacy of lonapegsomatropin as compared to somatropin in children and adolescents with TS, SHOX-D, SGA, or ISS
Measured: 52 Weeks
Secondary outcomes (5)
Annualized Height Velocity (AHV) (cm/year)
To evaluate lonapegsomatropin as compared to somatropin on additional measures of efficacy in children and adolescents with TS, SHOX-D, SGA, or ISS
Measured: 104 Weeks
Change from baseline in height standard deviation score (SDS)
To evaluate lonapegsomatropin as compared to somatropin on additional measures of efficacy in children and adolescents with TS, SHOX-D, SGA, or ISS
Measured: 52 Weeks and 104 Weeks
Change from baseline in Bone Age (years)
To evaluate the safety and tolerability of lonapegsomatropin in children and adolescents with TS, SHOX-D, SGA, or ISS via Central Reader
Measured: 52 Weeks and 104 Weeks
Change from baseline in ratio of Bone Age/chronological age
To evaluate the safety and tolerability of lonapegsomatropin in children and adolescents with TS, SHOX-D, SGA, or ISS via Central Reader
Measured: 52 Weeks and 104 Weeks
Number of participants with treatment-related adverse events (AEs)
To evaluate the safety and tolerability of lonapegsomatropin in children and adolescents with TS, SHOX-D, SGA, or ISS
Measured: 52 Weeks and 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start12 Dec 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3, parallel-arm, open-label, active-controlled, global, multicenter, randomized basket trial investigating the efficacy and safety of lonapegsomatropin compared to somatropin in prepubertal children and adolescents with growth failure or short stature due to growth hormone (GH) sufficient disorders - TS, SHOX-D, SGA, or ISS.
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221851
- Sponsor's protocol ID
- ASND0047
- Status last verified
- Nov 2026
- First submitted
- 14 Oct 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
- ClinicalTrials.gov ID
- NCT07221851
- Acronym / sponsor ID
- ASND0047
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Keywords
- Turner Syndrome, Noonan Syndrome, Growth Hormone, Short Stature, Growth Failure, Sex Chromosome Disorders, Chromosome Disorders, Endocrine System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Ascendis Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 28 Oct 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 basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3, parallel-arm, open-label, active-controlled, global, multicenter, randomized basket trial investigating the efficacy and safety of lonapegsomatropin compared to somatropin in prepubertal children and adolescents with growth failure or short stature due to growth hormone (GH) sufficient disorders - TS, SHOX-D, SGA, or ISS.
| Arm | Type | Receives |
|---|---|---|
| Lonapegsomatropin, once daily | Experimental | Combination Product: Lonapegsomatropin [SKYTROFA®]Participants will receive Lonapegsomatropin by subcutaneous injection for 2 years (104 weeks) |
| somatropin, once daily | Active comparator | Combination Product: Somatropin Pen InjectorParticipants will receive somatropin by subcutaneous injection for 1 year (52 weeks) followed by lonapegsomatropin for 1 year (52 weeks) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Chronological age between ≥2 and <18 years, at start of screening.
- Naïve to growth hormone and growth hormone promoting therapies.
- Prepubertal.
- Able to stand without assistance.
- Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:
Key exclusion criteria (26 listed)
- Advanced bone age X-ray by central reading defined as >20% above chronological age in months (Greulich 1959).
- Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.
- Current clinical diagnosis of diabetic retinopathy
- Any diagnosis or presence at screening of the following:
- Signs/symptoms of intracranial hypertension, active proliferative retinopathy.
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 |
|---|---|---|
| Lonapegsomatropin [SKYTROFA®]Subcutaneous injection once weekly | Combination product | Lonapegsomatropin, once daily |
| Somatropin Pen InjectorSubcutaneous injection once daily | Combination product | somatropin, once daily |
Primary outcome
Annualized Height Velocity (AHV) (cm/year)
Time frame: 52 Weeks
To evaluate the efficacy of lonapegsomatropin as compared to somatropin in children and adolescents with TS, SHOX-D, SGA, or ISS
5 secondary outcomes
Annualized Height Velocity (AHV) (cm/year)
Time frame: 104 Weeks
Change from baseline in height standard deviation score (SDS)
Time frame: 52 Weeks and 104 Weeks
Change from baseline in Bone Age (years)
Time frame: 52 Weeks and 104 Weeks
Change from baseline in ratio of Bone Age/chronological age
Time frame: 52 Weeks and 104 Weeks
Number of participants with treatment-related adverse events (AEs)
Time frame: 52 Weeks and 104 Weeks
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 5 Nov 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.
Medical Director, MD study director
Ascendis Pharma A/S
56 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lonapegsomatropin [SKYTROFA®] and Somatropin Pen Injector in people with Turner Syndrome and Short Stature Homeobox Gene Mutation, run by Ascendis Pharma A/S at 56 sites in 7 countries.
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 17 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, South Korea, Spain, France, Italy and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ascendis Registry Inquiries (+4561161658, asnd_registryinquiries@ascendispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Height Velocity (AHV) (cm/year) (time frame: 52 Weeks). 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 5 Nov 2026.