AzTrials
AzTrials

SGA, Turner Syndrome, Noonan Syndrome, ISSPhase 3REAL 8NCT05330325

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

A Phase 3 study testing Somapacitan and Norditropin® in people with SGA, Turner Syndrome, Noonan Syndrome, ISS, run by Novo Nordisk A/S at 199 sites in 33 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

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Read more about this study

Who is it for?
Ages 2 to 10 years
What is being tested?
Somapacitan and Norditropin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
199 sitesin 33 countries
Study dates
10 Aug 2022to 29 Oct 2027
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 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Informed consent of parent or legally acceptable representative of participant and child assent, as age appropriate must be obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
  • 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).
  • Prepubertal children:
  • Boys:
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  • Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
  • Testis volume below 4 mL
  • Girls:
  • Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
  • Tanner stage 1 for breast development: No palpable glandular breast tissue)
  • 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.
  • Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and sex according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
  • Body Mass Index below the 95th percentile according to Centers for Disease Control and Prevention, Body Mass Index-for-age growth charts.
  • Applicable to girls with TS:
  • Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis.*
  • Prepubertal girls:
  • Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
  • Tanner stage 1 for breast development: No palpable glandular breast tissue)
  • Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
  • Historical height measured 6-18 months prior to screening.
  • Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.
  • Applicable to children with NS:
  • Clinical diagnosis of NS according to van der Burgt score list
  • Prepubertal children:
  • Boys:
  • Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
  • Testis volume below 4 mL
  • Girls:
  • Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
  • Tanner stage 1 for breast development: No palpable glandular breast tissue)
  • Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
  • Historical height measured 6-18 months prior to screening.
  • Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.
  • Applicable to children with ISS:
  • Prepubertal children:
  • Boys:
  • Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
  • Testis volume below 4 mL
  • Girls:
  • Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
  • Tanner stage 1 for breast development: No palpable glandular breast tissue)
  • Bone age:
  • Boys:
  • Bone age below or equal to 12 years.
  • Bone age not delayed or advanced more than 2 years compared to chronological age.
  • Girls:
  • Bone age below or equal to 11 years.
  • Bone age not delayed or advanced more than 2 years compared to chronological age.
  • 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.
  • Historical height measured 6-18 months prior to screening.
  • One normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening or if such a test is not available for children with ISS, a test should be performed as part of the screening assessments and the result must be available prior to randomization.
  • If a 30-cell count is not available for patients with TS, a test should be done, and results must be available prior to randomization.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous randomization into same sub-study in this study.
  • Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
  • Children with suspected or confirmed growth hormone deficiency according to local practice.
  • laboratory of
  • fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
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  • 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 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.
  • Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
  • Diagnosis of attention deficit hyperactivity disorder (ADHD).
  • History or known presence of any malignancy, intracranial tumour, or intracranial cyst.
  • History or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
  • Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol.
  • The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator.
  • Current treatment with sex hormones or aromatase inhibitors.
  • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, 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/condition that can cause short stature such as, but not limited to, psychosocial deprivation, nutritional disorders, chronic systemic illness and chronic renal disease.
  • Applicable to children with SGA:
  • TS (including mosaicism).
  • NS.
  • Hormonal deficiencies.
  • Children who are small due to malnutrition defined as -2 standard deviations according to standards. 0¬-5 years: weight for height on World Health Organization Multicentre Growth Reference Study 2006. Above 5 years: World Health Organization 2007 Body Mass Index.
  • 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.
  • Applicable to children with TS:
  • NS.
  • Mosaicism below 10%.
  • TS with Y-chromosome mosaicism where gonadectomy has not been performed.
  • NYHA class II or above or requiring medication for any heart condition.
  • Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.
  • Applicable to children with NS:
  • TS (including mosaicism).
  • Noonan-related disorders: 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. Molecular genetic panel testing results must be available prior to randomisation to exclude these.
  • Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.
  • Applicable to children with ISS:
  • TS (including mosaicism).
  • NS.
  • Hormonal deficiencies.
  • Born small for gestational age (defined as birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
  • 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

199 sites in 33 countries.

199 sites in 33 countries

United States35 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Univ of AL at Birmingham_BRM

    Birmingham, Alabama, 35233

  • St. Luke's Children's Endo

    Boise, Idaho, 83712

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203

  • Rocky Mt Ped and Endo

    Centennial, Colorado, 80112

  • University Of Virginia Hospital

    Charlottesville, Virginia, 22903

  • CCHMC_Cinc

    Cincinnati, Ohio, 45229

  • UT Southwestern Med Cntr

    Dallas, Texas, 75235

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • NYU Langone Hospital-LI

    Garden City, New York, 11530

  • Ped Endo Assoc PC-G.V

    Greenwood Village, Colorado, 80111-2803

  • Rocky Mt Clin Res, LLC

    Idaho Falls, Idaho, 83404-7596

  • Riley Hosp for Child-Indiana U

    Indianapolis, Indiana, 46202

  • University OF Iowa

    Iowa City, Iowa, 52242

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi, 39216

  • Nemours Chld Clnc Jacksonville

    Jacksonville, Florida, 32207

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • NYU Langone Hospital-LI

    Mineola, New York, 11501

  • Univ of Minnesota M.C.H.

    Minneapolis, Minnesota, 55454

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07962

  • Univ Oklahoma Sci Ctr OK City

    Oklahoma City, Oklahoma, 73104

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina, 27610

  • Sutter Valley Med Fdt Ped Endo

    Sacramento, California, 95821

  • Children's Minnesota

    Saint Paul, Minnesota, 55102

  • Rady Childrens Hosp San Diego

    San Diego, California, 92123

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • MultiCare Inst for Res & Innov

    Tacoma, Washington, 98405

  • Childrens National Medical Ctr

    Washington D.C., District of Columbia, 20010-2978

  • Nemours/AI duPont Hosp-Chld

    Wilmington, Delaware, 19803

  • UMass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Japan20 sites

  • Fukuoka Children's Hospital_Endocrinology and Metabolism

    Fukuoka-shi, Fukuoka, 813-0017

  • Fukuoka Children's Hospital

    Fukuoka-shi, Fukuoka, 813-0017

  • Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo

    Kobe-shi, Hyogo, 650-0047

  • Hyogo Prefectual Kobe Children's Hospital_Metab & endo

    Kobe-shi, Hyogo, 650-0047

  • Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics

    Kyoto, 602-8566

  • Nara Prefecture General Medical Center_Nephrology

    Nara-shi, Nara, 630-8581

  • Nara Prefecture General Medical Center

    Nara-shi, Nara, 630-8581

  • Niigata University Medical & Dental Hospital_Pediatrics

    Niigata-shi, Niigata, 951 8520

  • Okayama Medical Center_Cardiology

    Okayama-shi, Okayama, 701-1192

  • Osaka City General Hospital, Pediatric Endocrinology and Me

    Osaka, 534-0021

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101

  • Saitama Children's Medical Center, Endocrinorogy&Metabolism

    Saitama-shi, Saitama, 330-8777

  • Hokkaido University Hospital, Pediatrics

    Sapporo, Hokkaido, 060-8648

  • Hokkaido University Hospital_Pediatrics

    Sapporo, Hokkaido, 060-8648

  • Shizuoka Children's Hospital, Department of Diabetes and metabolism

    Shizuoka-shi, Shizuoka, 420-8660

  • Institute of Science Tokyo Hospital_Pediatrics

    Tokyo, 113-8519

  • Institute of Science Tokyo Hospital

    Tokyo, 113-8519

  • National Center for Child Health and Development_Endo and Metabo

    Tokyo, 157 8535

  • Keio University Hospital_Pediatrics

    Tokyo, 160-8582

  • Fujita Health University Hospital, Pediatrics

    Toyoake, Aichi, 470-1192

Other trials in Japan

China14 sites

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • The First Bethune Hospital of Jilin University-Pediatric

    Changchun, Jilin, 130021

  • Hunan Children's Hospital-Child Health Center

    Changsha, Hunan, 410007

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Shandong Provincial Hospital-Pediatric

    Jinan, Shandong, 250098

  • Liuzhou Maternity and Child Healthcare Hospital-Child Healthcare

    Liuzhou, Guangxi, 545001

  • Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric

    Sanya, Hainan, 572032

  • Shanghai Children's Hospital -Endocrine Genetics and Metabolism

    Shanghai, Shanghai Municipality, 200062

  • Shanghai Children's Medical Center-Endocrine Genetics and Metabolism

    Shanghai, Shanghai Municipality, 200127

  • Wuhan Children Hospital-Endocrine Genetics and Metabolism

    Wuhan, Hubei, 430019

  • Wuhan Children Hospital

    Wuhan, Hubei, 430019

  • Tongji Hospital, Tongji Medical College of HUST-Pediatric

    Wuhan, Hubei, 430030

  • Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism

    Zhengzhou, Henan, 450018

Other trials in China

France12 sites

  • Centre Hospitalier Régional Universitaire d' Angers

    Angers, 49033

  • Centre Hospitalier Universitaire D'Angers-2

    Angers, 49100

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33000

  • CHU Pellegrin

    Bordeaux, 33076

  • Ap-Hp-Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hopital de Bicetre_Le Kremlin-Bicetre

    Le Kremlin-Bicêtre, 94275

  • Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2

    Marseille, 13005

  • Hopital de La Timone

    Marseille Cédex 05, 13385

  • Ap-Hp-Hopital Necker

    Paris, 75015

  • Hôpital Necker

    Paris, 75015

  • CHU de Toulouse

    Toulouse, 31059

  • Hopital Des Enfants

    Toulouse, 31059

Other trials in France

Greece9 sites

  • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

    Athens, 12462

  • Childrens' Hospital of Athens "Agia Sofia"

    Goudi/Athens, 115-27

  • P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development

    Goudi/Athens, 115-27

  • General University of Patra - Paediatric Department

    Pátrai, 26504

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 546-42

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, 54636

  • Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

    Thessaloniki, 54642

  • Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

    Thessaloniki, GR 54642

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, GR-54636

Other trials in Greece

Italy9 sites

  • IRCCS Meyer Firenze

    Florence, 50139

  • Ospedale Pediatrico Gaslini

    Genova, 16147

  • Ospedale San Raffaele S.r.l. - Unità Clinica Pediatria e neonatologia

    Milan, Lombardy, 20132

  • Ospedale San Raffaele UO di Pediatria e UO di Neonatologia

    Milan, 20132

  • Università degli Studi della Campania "L. Vanvitelli"

    Naples, 80138

  • Bambin Gesù

    Roma, 00165

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Rome, 00168

Other trials in Italy

Poland9 sites

  • Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie

    Cracow, 30-663

  • Uniwersytecki Szptal Dziecięcy w Krakowie

    Cracow, 30-663

  • UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,

    Gdansk, 80-952

  • Górnośląskie Centrum Zdrowia Dziecka Szpital Kliniczny Nr 6

    Katowice, 40-752

  • Klinika Endokrynologii i Chorób Metabolicznych

    Lodz, 93-338

  • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

    Rzeszów, Podkarpackie Voivodeship, 35-301

  • SPSK nr 1 im Prof. T Sokolowskiego

    Szczecin, 71-252

  • Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1

    Zabrze, 41-800

  • SPSK nr 1 im. prof.S.Szyszko w Zabrzu

    Zabrze, 41-800

Other trials in Poland

Thailand9 sites

  • Ramathibodi Hospital - Ped-Endo and Metabolism

    Bangkok, Ratchathewi, 10400

  • King Chulalongkorn Memorial hospital-Ped-Endocrinology

    Bangkok, 10330

  • King Chulalongkorn Memorial hospital_Ped-Endocrinology

    Bangkok, 10330

  • Phramongkutklao Hospital_Ped-Endo_Pediatrics

    Bangkok, 10400

  • PMK - Paediatrics Endocrinology Centre

    Bangkok, 10400

  • Siriraj Hospital_Dept of Paediatrics

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Ramathibodi Hospital - Ped-Endo and Metabolism

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

United Kingdom8 sites

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP

  • Evelina Children's Hospital - St Thomas'

    London, SE1 7EH

  • Evelina London Children's Hospital

    London, SE1 7EH

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

  • St George's Hospital

    Tooting, SW17 0RE

  • St Georges Hospital

    Tooting, SW17 0RE

Other trials in United Kingdom

Serbia6 sites

  • University Children's Hospital Tirsova

    Belgrade, 11000

  • Institute for Mother and Child Health Care of Serbia

    Belgrade, 11070

  • University Clinical Centre Kragujevac

    Kragujevac, 34000

  • University Clinical Centre Nis

    Niš, RS, 18 000

  • University Clinical Centre Nis

    Niš, 18 000

  • Institute for Health Care of Children and Adolescents

    Novi Sad, 21000

Other trials in Serbia

Germany5 sites

  • Universitätsklinikum Bonn - Kinderklinik

    Bonn, 53127

  • Universitätsklinikum Erlangen - Kinder- und Jugendklinik

    Erlangen, 91054

  • Endokrinologikum Frankfurt

    Frankfurt am Main, 60596

  • Klinik für Allgemeine Pädiatrie und Neonatologie

    Homburg, 66421

  • Universität des Saarlandes - Pädiatrie und Neonatologie

    Homburg, 66424

Other trials in Germany

Israel5 sites

  • Soroka MC - Pediatric Endocrinology

    Beersheba, 84101

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202

  • Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

    Tel HaShomer, 52621

  • Shamir MC - Pediatric and Adolescents Endocrinology unit

    Tsrifin, 7033001

Other trials in Israel

Malaysia5 sites

  • Hospital Al-Sultan Abdullah UiTM

    Bandar Puncak Alam, Selangor, 42300

  • University Technology MARA (UiTM) - Puncak Alam

    Bandar Puncak Alam Selangor Darul Ehsan, 42300

  • Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan

    Kota Bharu, Kelantan, 16150

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Portugal5 sites

  • ULS De São José, E.P.E.- Hospital D. Estefânia

    Lisbon, 1169-045

  • Centro Hospitalar Lisboa Norte

    Lisbon, 1649-035

  • Unidade De Santa Maria E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • ULS De Santo António, E.P.E. - Hospital de Santo António

    Porto, 4050-651

  • ULS De Gaia/Espinho_H.Santos Silva_Pediatria

    Vila Nova de Gaia, 4400-129

Other trials in Portugal

Austria4 sites

  • Krankenhaus der Stadt Dornbirn

    Dornbirn, 6850

  • Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)

    Linz, Upper Austria, 4020

  • LKH St. Poelten, Kinder-und Jugendheilkunde

    Sankt Pölten, 3100

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840

Other trials in Austria

Belgium4 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Brussels, 1200

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem, 2650

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000

Other trials in Belgium

Brazil4 sites

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040

  • Santa Casa Sao Paulo

    São Paulo, São Paulo, 01223-001

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Bulgaria4 sites

  • UMHAT - Dr. Georgi Stranski EAD

    Pleven, 5800

  • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics

    Plovdiv, 4002

  • SHATPD - Prof. Ivan Mitev EAD

    Sofia, 1606

  • UMHAT Sveta Marina EAD, First Pediatric Clinic

    Varna, 9010

Other trials in Bulgaria

Ireland4 sites

  • Cork University Hospital

    Cork

  • CHI at Temple Street

    Dublin, D01 XD99

  • CHI Crumlin Dept of Endocrinology

    Dublin, D12 N512

  • CHI Tallaght University Hospital

    Dublin, D24NR0A

Other trials in Ireland

South Africa4 sites

  • Department of Peadiatrics CHBAH

    Johannesburg, Gauteng, 1864

  • Dr Y Ganie's site

    Mayville, KwaZulu-Natal, 4058

  • Dr JC van Dyk's Rooms

    Pretoria, Gauteng, 0181

  • Dr K Pillay's site

    Westville, KwaZulu-Natal, 3600

Other trials in South Africa

South Korea4 sites

  • Chungnam National University Sejong Hospital

    Sejong-si, 30099

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Spain4 sites

  • H.Madrid Montepríncipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Madrid Montepríncipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

India3 sites

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029

  • Jehangir Clinical Development Centre

    Pune, Maharashtra, 411001

Other trials in India

Croatia2 sites

  • KBC "Sestre Milosrdnice"

    Zagreb, 10 000

  • KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

    Zagreb, 10000

Other trials in Croatia

Saudi Arabia2 sites

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713

  • National Guard Hospital

    Riyadh, 14812

Other trials in Saudi Arabia

Slovenia2 sites

  • PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism

    Ljubljana, 1525

  • University Children's Hospital

    Ljubljana, 1525

Other trials in Slovenia

Canada1 site

  • Children's Hosp-East Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

Finland1 site

  • HUS Pediatric Unit

    Helsinki, 00290

Other trials in Finland

Latvia1 site

  • Children's Clinical University Hospital

    Riga, 1004

Other trials in Latvia

Lithuania1 site

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161

Other trials in Lithuania

Mexico1 site

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190

Other trials in Mexico

Netherlands1 site

  • Erasmus MC

    Rotterdam, 3015 GD

Other trials in Netherlands

Switzerland1 site

  • Med. Kinder- und Poliklinik

    Bern, 3010

Other trials in Switzerland

About this study

Official title: A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.

Being tested
Somapacitan, Norditropin®
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 will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

  • Norditropin®Drug

    Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Study groups in NCT05330325
Study groupRoleWhat they receive
SomapacitanExperimentalParticipants will receive Somapacitan for 273 weeks
Receives: Drug: Somapacitan
Norditropin®Active comparatorParticipants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)
Receives: Drug: Norditropin®

What is being measured

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

  1. Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)

    Measured in centimeter per year (cm/year)

    Measured: From baseline (week 0) to visit 7 (week 52)

Secondary outcomes (15)

  1. Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS

    Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.

    Measured: From baseline (week 0) to visit 7 (week 52)

  2. Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS

    Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.

    Measured: From baseline (week 0) to visit 7 (week 52)

  3. Change in bone age reported separately for SGA, TS and NS

    Measured in ratio

    Measured: From baseline (week 0) to visit 7 (week 52)

  4. Change in bone age for ISS

    Measured in ratio

    Measured: From screening (visit 1) to visit 7 (week 52)

  5. Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS

    Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.

    Measured: From baseline (week 0) to visit 7 (week 52).

  6. Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS

    Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.

    Measured: From baseline (week 0) to visit 7 (week 52).

  7. Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS

    Measured in millimoles per litre (mmol/L)

    Measured: From screening (visit 1) to visit 7 (week 52)

  8. Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS

    Measured in percentage (%)

    Measured: From screening (visit 1) to visit 7 (week 52)

  9. Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS

    Measured in %

    Measured: From screening (visit 1) to visit 7 (week 52)

  10. Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS

    Measured in percentage of HbA1c

    Measured: From screening (visit 1) to visit 7 (week 52)

  11. Weekly average somapacitan concentration (Cavg) based on population PK analysis

    Measured in nanograms per milliliter (ng/mL)

    Measured: From visit 3 (week 4) to visit 7 (week 52)

  12. Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS

    Measured in mmol/L

    Measured: From screening (visit 1) to visit 15 (week 156)

  13. Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS

    Measured in %

    Measured: From screening (visit 1) to visit 15 (week 156)

  14. Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS

    Measured in %

    Measured: From screening (visit 1) to visit 15 (week 156)

  15. Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS

    Measured in percentage of HbA1c

    Measured: From screening (visit 1) to visit 15 (week 156)

Timeline

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

  1. First posted15 Apr 2022
  2. Study start10 Aug 2022
  3. Primary completion5 Aug 2024
  4. Study completion29 Oct 2027 (estimated)

Resources

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
Masking
None (open label)
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05330325
Sponsor's protocol ID
NN8640-4467
Other IDs
2021-005607-13, U1111-1270-0862
Acronym
REAL 8
Status last verified
Jun 2026
First submitted
8 Apr 2022
Last updated
12 Jun 2026
Results posted
No
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

Publications

  • Jorge AAL, Albanese A, Hojby M, Soltysik K, Edouard T, Grandone A, Tansey M, Mori J. Once-weekly somapacitan in children with Noonan syndrome: randomized controlled phase 3 trial. Eur J Endocrinol. 2026 Mar 4;194(3):393-403. doi: 10.1093/ejendo/lvag041.

    PubMed 41774755

  • Abuzzahab J, Dauber A, Hojby M, Soltysik K, Kawai M, Murray PG, Phillip M, Battelino T. Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study. Eur J Endocrinol. 2026 Feb 4;194(2):242-253. doi: 10.1093/ejendo/lvag027.

    PubMed 41712606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Somapacitan and Norditropin® in people with SGA, Turner Syndrome, Noonan Syndrome, ISS, run by Novo Nordisk A/S at 199 sites in 33 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 53 inclusion and 42 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, Japan, China, France, Greece and 28 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?

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?

Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS) (time frame: From baseline (week 0) to visit 7 (week 52)). 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 NCT05330325, which also lists 2 linked publications.

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 12 Jun 2026.

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