SGAPhase 3REAL 9NCT05723835

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

A Phase 3 study testing Somapacitan in people with SGA and Turner Syndrome, run by Novo Nordisk A/S at 18 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 10 to 18 years
Conditions the study is for: SGA, Turner Syndrome, Noonan Syndrome
What is being tested?: Somapacitan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 18 sitesin 6 countries
Study dates: 1 Feb 2023to 29 Oct 2027
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Applicable to children with SGA:
Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
Age:
Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age less than (<) 14 years for females and bone age < 16 years for males.

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For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
Applicable to children with TS:
Diagnosis of TS according to local clinical practice.
Age:
Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Impaired height defined as at least 2.0 standard deviation below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array.
Applicable to children with NS:
Diagnosis of NS according to local clinical practice.
Age:
Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Clinical diagnosis of NS according to van der Burgt score list and genetic test result or confirmed mutation in any of the genes associated with NS before allocation.
Applicable to children with ISS:
Age:
Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening
For GH treatment naïve participants: Normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening.
For GH treatment naïve participants: Bone age not delayed more than 2 years compared to chronological age at screening.

Who cannot join

Children with suspected or confirmed growth hormone deficiency according to local practice.
Children diagnosed with diabetes mellitus or screening values from the central laboratory.
Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) [7.0 millimoles per litre (mmol/L)] or
Glycated hemoglobin (HbA1c) above or equal to 6.5%.
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.

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History or known presence of malignancy including intracranial tumours.
Applicable to children with SGA:
Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Poorly controlled or uncontrolled hormonal deficiencies.
Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis or absence of GH receptors.
Applicable to children with TS:
Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Mosaicism below 10%.
TS with Y-chromosome mosaicism where gonadectomy has not been performed.
New York Heart Association (NYHA) class II or above or requiring medication for any heart condition.
Applicable to children with NS:
Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Noonan-related disorders including but not limited to: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome.
Applicable to children with ISS:
Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Poorly controlled or uncontrolled hormonal deficiencies.
Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.

Trial locations and contacts

18 sites in 6 countries.

Country

City, postcode or hospital

18 sites in 6 countries

United States6 sites

Univ of AL at Birmingham_BRM
Birmingham, Alabama, 35233
Rocky Mt Ped and Endo
Centennial, Colorado, 80112
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, 83404-7596
Sutter Valley Med Fdt Ped Endo
Sacramento, California, 95821
Children's Minnesota
Saint Paul, Minnesota, 55102
Childrens National Medical Ctr
Washington D.C., District of Columbia, 20010-2978

Other trials in United States

Poland5 sites

UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,
Gdansk, 80-952
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, 35-301
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, 35-301
SPSK nr 1 im. prof.S.Szyszko w Zabrzu
Zabrze, 41-800

Other trials in Poland

South Korea3 sites

Asan Medical Center
Seoul, 05505
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Pusan National University Yangsan Hospital
Yangsan, 50612

Other trials in South Korea

Malaysia2 sites

Hospital Al-Sultan Abdullah UiTM
Bandar Puncak Alam, Selangor, 42300
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Netherlands1 site

Erasmus MC
Rotterdam, 3015 GD

Other trials in Netherlands

Spain1 site

Hospital Vall d'Hebron
Barcelona, 08035

Other trials in Spain

About this study

Official title: A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.

Conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS
Being tested: Somapacitan
Medical subject headings: Turner Syndrome, Noonan Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SomapacitanDrug
Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.

Study groups in NCT05723835
Study group	Role	What they receive
Somapacitan	Experimental	Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase. Receives: Drug: Somapacitan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26

Secondary outcomes (32)

Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication NS. An NS is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature
This outcome measure reported number of AEs possibly or probably related to somapacitan in participants with short stature for indication ISS. ISS describes short children with normal GH secretion and it is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 26
Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured: From baseline (Week 0) to Week 156
Height Velocity Reported Children Born Small for Gestational Age
This outcome measure reported height velocity in children with short stature for indication SGA. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Measured: From Baseline (Week 0) to Week 26
Height Velocity Reported for Turner Syndrome
This outcome measure reported height velocity in children with short stature for indication TS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Measured: From Baseline (Week 0) to Week 26
Height Velocity Reported for Noonan Syndrome
This outcome measure reported height velocity in children with short stature for indication NS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years).
Measured: From Baseline (Week 0) to Week 26
Height Velocity Reported for Idiopathic Short Stature
This outcome measure reported height velocity in children with short stature for indication ISS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Measured: From Baseline (Week 0) to Week 26
Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age
This outcome measure reported height standard deviation scores in children with short stature for indication SGA. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit and SD indicates the standard deviation (SD). The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Turner Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication TS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication NS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature
This outcome measure reported height standard deviation scores in children with short stature for indication ISS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age
This outcome measure reported change in height velocity SDS in children with short stature for indication SGA. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline Week 0 subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication TS. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline (Week 0) subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication NS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature
This outcome measure reported change in height velocity SDS in children with short stature for indication ISS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGF-1 SDS in children with short stature for indication SGA. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication TS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication NS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature
This outcome measure reported change in IGF-1 SDS in children with short stature for indication ISS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication SGA. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication TS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication NS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication ISS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Measured: Baseline (Week 0), Week 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children born small for gestational age who were either naïve or non-naïve to GH treatment.
Measured: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Turner Syndrome who were either naïve or non-naïve to GH treatment.
Measured: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Noonan Syndrome who were either naïve or non-naïve to GH treatment.
Measured: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with idiopathic short stature who were either naïve or non-naïve to GH treatment.
Measured: Weeks 4, 8, 13, 20 and 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202329 Oct 2027

First posted13 Feb 2023
Study start1 Feb 2023
Primary completion7 Jun 2024
Study completion29 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SGAStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05723835
Sponsor's protocol ID: NN8640-4469
Other IDs: U1111-1277-9765, 2022-501055-87
Acronym: REAL 9
Status last verified: Aug 2026
First submitted: 29 Jan 2023
Last updated: 13 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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All SGA trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature
ClinicalTrials.gov ID: NCT05723835
Acronym / sponsor ID: REAL 9 / NN8640-4469
Conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 47 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 1 Feb 2023 (actual)
Primary completion: 7 Jun 2024 (actual)
Study completion: 29 Oct 2027 (estimated)
First posted: 13 Feb 2023 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Somapacitan	Experimental	Drug: SomapacitanParticipants will receive Somapacitan for 26-week main phase followed by 130-week extension phase.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (29 listed)

Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
Age:
Open epiphyses; defined as bone age less than (<) 14 years for females and bone age < 16 years for males.
For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
Diagnosis of TS according to local clinical practice.

Key exclusion criteria (32 listed)

Children with suspected or confirmed growth hormone deficiency according to local practice.
Children diagnosed with diabetes mellitus or screening values from the central laboratory.
Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) [7.0 millimoles per litre (mmol/L)] or
Glycated hemoglobin (HbA1c) above or equal to 6.5%.
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.

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
SomapacitanSomapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.	Drug	Somapacitan

Primary outcome

Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
Time frame: From baseline (Week 0) to Week 26
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
Time frame: From baseline (Week 0) to Week 26
This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
Time frame: From baseline (Week 0) to Week 26
This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26
Time frame: From baseline (Week 0) to Week 26
This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.

32 secondary outcomes

Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age
Time frame: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome
Time frame: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome
Time frame: From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature
Time frame: From baseline (Week 0) to Week 26
Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156
Time frame: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156
Time frame: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156
Time frame: From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156
Time frame: From baseline (Week 0) to Week 156
Height Velocity Reported Children Born Small for Gestational Age
Time frame: From Baseline (Week 0) to Week 26
Height Velocity Reported for Turner Syndrome
Time frame: From Baseline (Week 0) to Week 26
Height Velocity Reported for Noonan Syndrome
Time frame: From Baseline (Week 0) to Week 26
Height Velocity Reported for Idiopathic Short Stature
Time frame: From Baseline (Week 0) to Week 26
Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age
Time frame: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Turner Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Noonan Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature
Time frame: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age
Time frame: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age
Time frame: Baseline (week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome
Time frame: Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature
Time frame: Baseline (Week 0), Week 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age
Time frame: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome
Time frame: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome
Time frame: Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature
Time frame: Weeks 4, 8, 13, 20 and 26

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SGA_somapacitan (GH Treatment Naïve)	4	4
SGA_somapacitan (Previously Treated With GH)	8	8
TS_somapacitan (GH Treatment Naïve)	3	3
TS_somapacitan (Previously Treated With GH)	8	8
NS_somapacitan (GH Treatment Naïve)	6	6
NS_somapacitan (Previously Treated With GH)	7	7
ISS_somapacitan (GH Treatment Naïve)	2	2
ISS_somapacitan (Previously Treated With GH)	9	9

Primary outcome: Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26

Time frame: From baseline (Week 0) to Week 26. Number. Unit: Events

Measure	SGA_somapacitan (GH Treatment Naïve) n = 4	SGA_somapacitan (Previously Treated With GH) n = 8
Value	4	10

Population analysed: Safety analysis set included all participants who were exposed to study treatment.

Primary outcome: Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26

Time frame: From baseline (Week 0) to Week 26. Number. Unit: Events

Measure	TS_somapacitan (GH Treatment Naïve) n = 3	TS_somapacitan (Previously Treated With GH) n = 8
Value	4	18

Population analysed: Safety analysis set included all participants who were exposed to study treatment.

Primary outcome: Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26

Time frame: From baseline (Week 0) to Week 26. Number. Unit: Events

Measure	NS_somapacitan (GH Treatment Naïve) n = 6	NS_somapacitan (Previously Treated With GH) n = 7
Value	13	11

Population analysed: Safety analysis set included all participants who were exposed to study treatment.

Primary outcome: Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26

Time frame: From baseline (Week 0) to Week 26. Number. Unit: Events

Measure	ISS_somapacitan (GH Treatment Naïve) n = 2	ISS_somapacitan (Previously Treated With GH) n = 9
Value	9	22

Population analysed: Safety analysis set included all participants who were exposed to study treatment.

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline (Week 0) up to Week 94 (approximately, Data cut off date: 24Nov2024). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SGA_somapacitan (GH Treatment Naïve)	0 of 4 (0%)	3 of 4 (75%)	0 of 4
SGA_somapacitan (Previously Treated With GH)	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
TS_somapacitan (GH Treatment Naïve)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
TS_somapacitan (Previously Treated With GH)	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8
NS_somapacitan (GH Treatment Naïve)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
NS_somapacitan (Previously Treated With GH)	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
ISS_somapacitan (GH Treatment Naïve)	0 of 2 (0%)	2 of 2 (100%)	0 of 2
ISS_somapacitan (Previously Treated With GH)	1 of 9 (11.1%)	8 of 9 (88.9%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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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.

Clinical Transparency (dept. 2834) study director

Novo Nordisk A/S

18 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Somapacitan in people with SGA and Turner Syndrome, run by Novo Nordisk A/S at 18 sites in 6 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 29 inclusion and 32 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Poland, South Korea, Malaysia, Netherlands and 1 more country. 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?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26 (time frame: From baseline (Week 0) to Week 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723835.

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 13 Aug 2026.