A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
REAL 8
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
3 other identifiers
interventional
412
33 countries
199
Brief 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®. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2022
Longer than P75 for phase_3
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2027
ExpectedApril 24, 2026
April 1, 2026
2 years
April 8, 2022
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (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)
From baseline (week 0) to visit 7 (week 52)
Secondary Outcomes (15)
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS
From baseline (week 0) to visit 7 (week 52)
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS
From baseline (week 0) to visit 7 (week 52)
Change in bone age reported separately for SGA, TS and NS
From baseline (week 0) to visit 7 (week 52)
Change in bone age for ISS
From screening (visit 1) to visit 7 (week 52)
Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS
From baseline (week 0) to visit 7 (week 52).
- +10 more secondary outcomes
Study Arms (2)
Somapacitan
EXPERIMENTALParticipants will receive Somapacitan for 273 weeks
Norditropin®
ACTIVE COMPARATORParticipants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)
Interventions
Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.
Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- +38 more criteria
You may not qualify if:
- 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
- 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.
- 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.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (199)
Univ of AL at Birmingham_BRM
Birmingham, Alabama, 35233, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027, United States
Sutter Valley Med Fdt Ped Endo
Sacramento, California, 95821, United States
Rady Childrens Hosp San Diego
San Diego, California, 92123, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Rocky Mt Ped and Endo
Centennial, Colorado, 80112, United States
Ped Endo Assoc PC-G.V
Greenwood Village, Colorado, 80111-2803, United States
Nemours/AI duPont Hosp-Chld
Wilmington, Delaware, 19803, United States
Childrens National Medical Ctr
Washington D.C., District of Columbia, 20010-2978, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, 32207, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
St. Luke's Children's Endo
Boise, Idaho, 83712, United States
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, 83404-7596, United States
Riley Hosp for Child-Indiana U
Indianapolis, Indiana, 46202, United States
University OF Iowa
Iowa City, Iowa, 52242, United States
UMass Medical School
Worcester, Massachusetts, 01655, United States
Univ of Minnesota M.C.H.
Minneapolis, Minnesota, 55454, United States
Children's Minnesota
Saint Paul, Minnesota, 55102, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Goryeb Children's Hospital
Morristown, New Jersey, 07962, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203, United States
NYU Langone Hospital-LI
Garden City, New York, 11530, United States
NYU Langone Hospital-LI
Mineola, New York, 11501, United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, 27610, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
CCHMC_Cinc
Cincinnati, Ohio, 45229, United States
Univ Oklahoma Sci Ctr OK City
Oklahoma City, Oklahoma, 73104, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
UT Southwestern Med Cntr
Dallas, Texas, 75235, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
University Of Virginia Hospital
Charlottesville, Virginia, 22903, United States
MultiCare Inst for Res & Innov
Tacoma, Washington, 98405, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)
Linz, Upper Austria, 4020, Austria
Krankenhaus der Stadt Dornbirn
Dornbirn, 6850, Austria
LKH St. Poelten, Kinder-und Jugendheilkunde
Sankt Pölten, 3100, Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, 4840, Austria
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, 1200, Belgium
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem, 2650, Belgium
UZ Leuven - Kindergeneeskunde
Leuven, 3000, Belgium
Centro de Diabetes Curitiba
Curitiba, Paraná, 80810-040, Brazil
Santa Casa Sao Paulo
São Paulo, São Paulo, 01223-001, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000, Brazil
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000, Brazil
UMHAT - Dr. Georgi Stranski EAD
Pleven, 5800, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, 4002, Bulgaria
SHATPD - Prof. Ivan Mitev EAD
Sofia, 1606, Bulgaria
UMHAT Sveta Marina EAD, First Pediatric Clinic
Varna, 9010, Bulgaria
Children's Hosp-East Ontario
Ottawa, Ontario, K1H 8L1, Canada
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Liuzhou Maternity and Child Healthcare Hospital-Child Healthcare
Liuchow, Guangxi, 545001, China
Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric
Sanya, Hainan, 572032, China
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou, Henan, 450018, China
Wuhan Children Hospital-Endocrine Genetics and Metabolism
Wuhan, Hubei, 430019, China
Wuhan Children Hospital
Wuhan, Hubei, 430019, China
Tongji Hospital, Tongji Medical College of HUST-Pediatric
Wuhan, Hubei, 430030, China
Hunan Children's Hospital-Child Health Center
Changsha, Hunan, 410007, China
The First Bethune Hospital of Jilin University-Pediatric
Changchun, Jilin, 130021, China
Shandong Provincial Hospital-Pediatric
Jinan, Shandong, 250098, China
Shanghai Children's Hospital -Endocrine Genetics and Metabolism
Shanghai, Shanghai Municipality, 200062, China
Shanghai Children's Medical Center-Endocrine Genetics and Metabolism
Shanghai, Shanghai Municipality, 200127, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610000, China
KBC "Sestre Milosrdnice"
Zagreb, 10 000, Croatia
KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes
Zagreb, 10000, Croatia
HUS Pediatric Unit
Helsinki, 00290, Finland
Centre Hospitalier Régional Universitaire d' Angers
Angers, 49033, France
Centre Hospitalier Universitaire D'Angers-2
Angers, 49100, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, 33000, France
CHU Pellegrin
Bordeaux, 33076, France
Ap-Hp-Hopital de Bicetre
Le Kremlin-Bicêtre, 94270, France
Hopital de Bicetre_Le Kremlin-Bicetre
Le Kremlin-Bicêtre, 94275, France
Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
Marseille, 13005, France
Hopital de La Timone
Marseille Cédex 05, 13385, France
Ap-Hp-Hopital Necker
Paris, 75015, France
Hôpital Necker
Paris, 75015, France
CHU de Toulouse
Toulouse, 31059, France
Hopital Des Enfants
Toulouse, 31059, France
Universitätsklinikum Bonn - Kinderklinik
Bonn, 53127, Germany
Universitätsklinikum Erlangen - Kinder- und Jugendklinik
Erlangen, 91054, Germany
Endokrinologikum Frankfurt
Frankfurt am Main, 60596, Germany
Klinik für Allgemeine Pädiatrie und Neonatologie
Homburg, 66421, Germany
Universität des Saarlandes - Pädiatrie und Neonatologie
Homburg, 66424, Germany
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, 12462, Greece
Childrens' Hospital of Athens "Agia Sofia"
Goudi/Athens, 115-27, Greece
P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development
Goudi/Athens, 115-27, Greece
General University of Patra - Paediatric Department
Pátrai, 26504, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 546-42, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
Thessaloniki, 54642, Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
Thessaloniki, GR 54642, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, GR-54636, Greece
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, 682041, India
Jehangir Clinical Development Centre
Pune, Maharashtra, 411001, India
All India Institute of Medical Sciences
New Dehli, New Delhi, 110029, India
Cork University Hospital
Cork, Ireland
CHI at Temple Street
Dublin, D01 XD99, Ireland
CHI Crumlin Dept of Endocrinology
Dublin, D12 N512, Ireland
CHI Tallaght University Hospital
Dublin, D24NR0A, Ireland
Soroka MC - Pediatric Endocrinology
Beersheba, 84101, Israel
Rambam MC - Department of Pediatrics A
Haifa, 31096, Israel
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, 49202, Israel
Sheba MC - Pediatric endocrinology and adolescent diabetes clinics
Tel Litwinsky, 52621, Israel
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin, 7033001, Israel
Ospedale San Raffaele S.r.l. - Unità Clinica Pediatria e neonatologia
Milan, Lombardy, 20132, Italy
IRCCS Meyer Firenze
Florence, 50139, Italy
Ospedale Pediatrico Gaslini
Genova, 16147, Italy
Ospedale San Raffaele UO di Pediatria e UO di Neonatologia
Milan, 20132, Italy
Università degli Studi della Campania "L. Vanvitelli"
Naples, 80138, Italy
Bambin Gesù
Roma, 00165, Italy
Ospedale Pediatrico Bambino Gesu
Roma, 00165, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Rome, 00168, Italy
Fukuoka Children's Hospital_Endocrinology and Metabolism
Fukuoka-shi, Fukuoka, 813-0017, Japan
Fukuoka Children's Hospital
Fukuoka-shi, Fukuoka, 813-0017, Japan
Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo
Kobe-shi, Hyogo, 650-0047, Japan
Hyogo Prefectual Kobe Children's Hospital_Metab & endo
Kobe-shi, Hyogo, 650-0047, Japan
Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
Kyoto, 602-8566, Japan
Nara Prefecture General Medical Center_Nephrology
Nara-shi, Nara, 630-8581, Japan
Nara Prefecture General Medical Center
Nara-shi, Nara, 630-8581, Japan
Niigata University Medical & Dental Hospital_Pediatrics
Niigata-shi, Niigata, 951 8520, Japan
Okayama Medical Center_Cardiology
Okayama-shi, Okayama, 701-1192, Japan
Osaka City General Hospital, Pediatric Endocrinology and Me
Osaka, 534-0021, Japan
Osaka Women's and Children's Hospital
Osaka, 594-1101, Japan
Saitama Children's Medical Center, Endocrinorogy&Metabolism
Saitama-shi, Saitama, 330-8777, Japan
Hokkaido University Hospital, Pediatrics
Sapporo, Hokkaido, 060-8648, Japan
Hokkaido University Hospital_Pediatrics
Sapporo, Hokkaido, 060-8648, Japan
Shizuoka Children's Hospital, Department of Diabetes and metabolism
Shizuoka-shi, Shizuoka, 420-8660, Japan
Institute of Science Tokyo Hospital_Pediatrics
Tokyo, 113-8519, Japan
Institute of Science Tokyo Hospital
Tokyo, 113-8519, Japan
National Center for Child Health and Development_Endo and Metabo
Tokyo, 157 8535, Japan
Keio University Hospital_Pediatrics
Tokyo, 160-8582, Japan
Fujita Health University Hospital, Pediatrics
Toyoake, Aichi, 470-1192, Japan
Children's Clinical University Hospital
Riga, 1004, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161, Lithuania
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
Kota Bharu, Kelantan, 16150, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Al-Sultan Abdullah UiTM
Bandar Puncak Alam, Selangor, 42300, Malaysia
University Technology MARA (UiTM) - Puncak Alam
Bandar Puncak Alam Selangor Darul Ehsan, 42300, Malaysia
Consultorio de Endocrinología y Pediatría
Puebla City, 72190, Mexico
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, 35-301, Poland
Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie
Cracow, 30-663, Poland
Uniwersytecki Szptal Dziecięcy w Krakowie
Cracow, 30-663, Poland
UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,
Gdansk, 80-952, Poland
Górnośląskie Centrum Zdrowia Dziecka Szpital Kliniczny Nr 6
Katowice, 40-752, Poland
Klinika Endokrynologii i Chorób Metabolicznych
Lodz, 93-338, Poland
SPSK nr 1 im Prof. T Sokolowskiego
Szczecin, 71-252, Poland
Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1
Zabrze, 41-800, Poland
SPSK nr 1 im. prof.S.Szyszko w Zabrzu
Zabrze, 41-800, Poland
Unidade Local De Saúde De São José, E.P.E.- Hospital D. Estefânia
Lisbon, 1169-045, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035, Portugal
Unidade Local De Saúde De Santa Maria E.P.E.
Lisbon, 1649-035, Portugal
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, 4050-651, Portugal
ULS De Gaia/Espinho_H.Santos Silva_Pediatria
Vila Nova de Gaia, 4400-129, Portugal
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713, Saudi Arabia
National Guard Hospital
Riyadh, 14812, Saudi Arabia
University Clinical Centre Nis
Niš, RS, 18 000, Serbia
University Children's Hospital Tirsova
Belgrade, 11000, Serbia
Institute for Mother and Child Health Care of Serbia
Belgrade, 11070, Serbia
University Clinical Centre Kragujevac
Kragujevac, 34000, Serbia
University Clinical Centre Nis
Niš, 18 000, Serbia
Institute for Health Care of Children and Adolescents
Novi Sad, 21000, Serbia
PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism
Ljubljana, 1525, Slovenia
University Children's Hospital
Ljubljana, 1525, Slovenia
Department of Peadiatrics CHBAH
Johannesburg, Gauteng, 1864, South Africa
Dr JC van Dyk's Rooms
Pretoria, Gauteng, 0181, South Africa
Dr Y Ganie's site
Mayville, KwaZulu-Natal, 4058, South Africa
Dr K Pillay's site
Westville, KwaZulu-Natal, 3600, South Africa
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chungnam National University Sejong Hospital
Sejong-si, 30099, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
H.Madrid Montepríncipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital Madrid Montepríncipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950, Spain
Med. Kinder- und Poliklinik
Bern, 3010, Switzerland
Ramathibodi Hospital - Ped-Endo and Metabolism
Ratchathewi, Bangkok, 10400, Thailand
Ramathibodi Hospital - Ped-Endo and Metabolism
Bangkok, Ratchathewi, 10400, Thailand
King Chulalongkorn Memorial hospital-Ped-Endocrinology
Bangkok, 10330, Thailand
King Chulalongkorn Memorial hospital_Ped-Endocrinology
Bangkok, 10330, Thailand
Phramongkutklao Hospital_Ped-Endo_Pediatrics
Bangkok, 10400, Thailand
PMK - Paediatrics Endocrinology Centre
Bangkok, 10400, Thailand
Siriraj Hospital_Dept of Paediatrics
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Addenbrooke's Hospital_Cambridge
Cambridge, CB2 0QQ, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AP, United Kingdom
Evelina Children's Hospital - St Thomas'
London, SE1 7EH, United Kingdom
Evelina London Children's Hospital
London, SE1 7EH, United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 9WL, United Kingdom
St George's Hospital
Tooting, SW17 0RE, United Kingdom
St Georges Hospital
Tooting, SW17 0RE, United Kingdom
Related Publications (2)
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.
PMID: 41774755DERIVEDAbuzzahab 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.
PMID: 41712606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency dept. 2834
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 15, 2022
Study Start
August 10, 2022
Primary Completion
August 5, 2024
Study Completion (Estimated)
October 29, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com