A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Interventions
- Registration Number
- NCT05330325
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somapacitan Somapacitan Participants will receive Somapacitan for 273 weeks Norditropin® Norditropin® Participants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)
- Primary Outcome Measures
Name Time Method Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS) From baseline (week 0) to visit 7 (week 52) Measured in centimeter per year (cm/year)
- Secondary Outcome Measures
Name Time Method Change in bone age reported separately for SGA, TS and NS From baseline (week 0) to visit 7 (week 52) Measured in ratio
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). Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in percentage of HbA1c
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS From baseline (week 0) to visit 7 (week 52) Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in mmol/L
Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in %
Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in %
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS From baseline (week 0) to visit 7 (week 52) Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in bone age for ISS From screening (visit 1) to visit 7 (week 52) Measured in ratio
Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS From baseline (week 0) to visit 7 (week 52). Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 7 (week 52) Measured in %
Weekly average somapacitan concentration (Cavg) based on population PK analysis From visit 3 (week 4) to visit 7 (week 52) Measured in nanograms per milliliter (ng/mL)
Trial Locations
- Locations (155)
Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
🇯🇵Kyoto, Japan
Nara Prefecture General Medical Center
🇯🇵Nara-shi, Nara, Japan
Institute of Science Tokyo Hospital
🇯🇵Tokyo, Japan
National Center for Child Health and Dev, Endo and Metabo
🇯🇵Tokyo, Japan
Fujita Health University Hospital, Pediatrics
🇯🇵Toyoake, Aichi, Japan
Chungnam National University Sejong Hospital
🇰🇷Sejong-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Children's Clinical University Hospital
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
🇱🇹Kaunas, Lithuania
Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
🇲🇾Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
P & A Kyriakou Childrens' Hospital
🇬🇷Goudi/Athens, Greece
General University of Patra - Paediatric Department
🇬🇷Patra, Greece
'Ippokrateio' General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
"AHEPA" University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
🇬🇷Thessaloniki, Greece
Niigata University Medical & Dental Hospital, Pediatrics
🇯🇵Niigata-shi, Niigata, Japan
Okayama Medical Center
🇯🇵Okayama-shi, Okayama, Japan
Osaka City General Hospital, Pediatric Endocrinology and Me
🇯🇵Osaka, Japan
Osaka Women's and Children's Hospital
🇯🇵Osaka, Japan
Saitama Children's Medical Center, Endocrinorogy&Metabolism
🇯🇵Saitama-shi, Saitama, Japan
Hokkaido University Hospital, Pediatrics
🇯🇵Sapporo, Hokkaido, Japan
Shizuoka Children's Hospital, Department of Diabetes and metabolism
🇯🇵Shizuoka-shi, Shizuoka, Japan
Università degli Studi della Campania "L. Vanvitelli"
🇮🇹Napoli, Italy
Bambin Gesù
🇮🇹Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Fukuoka Children's Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo
🇯🇵Kobe-shi, Hyogo, Japan
Rambam Medical Center Children A Dept.
🇮🇱Haifa, Israel
Endrocrinology & DM Schneider MC
🇮🇱Petah Tikva, Israel
Children's Hospital Los Angeles - Endocrinology
🇺🇸Los Angeles, California, United States
Sutter Valley Med Fdt Ped Endo
🇺🇸Sacramento, California, United States
Rady Childrens Hosp San Diego
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Ped Endo Assoc PC-G.V
🇺🇸Greenwood Village, Colorado, United States
Nemours/AI duPont Hosp-Chld
🇺🇸Wilmington, Delaware, United States
Childrens National Medical Ctr
🇺🇸Washington, District of Columbia, United States
Nemours Chld Clnc Jacksonville
🇺🇸Jacksonville, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
St. Luke's Children's Endo
🇺🇸Boise, Idaho, United States
Rocky Mt Clin Res, LLC
🇺🇸Idaho Falls, Idaho, United States
Riley Hosp for Child-Indiana U
🇺🇸Indianapolis, Indiana, United States
University OF Iowa
🇺🇸Iowa City, Iowa, United States
Univ of Minnesota M.C.H.
🇺🇸Minneapolis, Minnesota, United States
Children's Minnesota
🇺🇸Saint Paul, Minnesota, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Goryeb Children's Hospital
🇺🇸Morristown, New Jersey, United States
NYU Langone Hospital-LI
🇺🇸Mineola, New York, United States
WakeMed Childn Endo-Dbt_Raleig
🇺🇸Raleigh, North Carolina, United States
CCHMC_Cinc
🇺🇸Cincinnati, Ohio, United States
UPMC Child Hosp-Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
MultiCare Inst for Res & Innov
🇺🇸Tacoma, Washington, United States
Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)
🇦🇹Linz, Upper Austria, Austria
UZ Brussel
🇧🇪Brussel, Belgium
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
🇧🇪Bruxelles, Belgium
UZA - UZ Antwerpen - Kinderziekenhuis
🇧🇪Edegem, Belgium
UZ Leuven - Kindergeneeskunde
🇧🇪Leuven, Belgium
Centro de Diabetes Curitiba
🇧🇷Curitiba, Parana, Brazil
CPQuali Pesquisa Clínica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
Santa Casa Sao Paulo
🇧🇷Sao Paulo, SP, Brazil
Hosp. Das Clínicas Da Fac. de Med.Da Universidade de Sp
🇧🇷São Paulo, SP, Brazil
UMHAT "Dr. Georgi Stranski" Pleven
🇧🇬Pleven, Bulgaria
UMHAT "Sveti Georgi" Clinica of Pediatric
🇧🇬Plovdiv, Bulgaria
"SHATPD - Prof. Ivan Mitev" EAD
🇧🇬Sofia, Bulgaria
MHAT "Sveta Marina"
🇧🇬Varna, Bulgaria
Children's Hosp-East Ontario
🇨🇦Ottawa, Ontario, Canada
Beijing Children's Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric
🇨🇳Sanya, Hainan, China
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
🇨🇳Zhengzhou, Henan, China
Wuhan Children Hospital-Endocrine Genetics and Metabolism
🇨🇳Wuhan, Hubei, China
Wuhan Children Hospital
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST-Pediatric
🇨🇳Wuhan, Hubei, China
Hunan Children's Hospital-Child health centre
🇨🇳Changsha, Hunan, China
The First Bethune Hospital of Jilin University-Pediatric
🇨🇳Changchun, Jilin, China
Ospedale San Raffaele UO di Pediatria e UO di Neonatologia
🇮🇹Milano, Italy
Shandong Provincial Hospital-Pediatric
🇨🇳Jinan, Shandong, China
Shanghai Children's Medical Center-Endocrine Genetics and Metabolism
🇨🇳Shanghai, Shanghai, China
Chengdu Women's and Children's central hospital
🇨🇳Chengdu, Sichuan, China
KBC "Sestre Milosrdnice"
🇭🇷Zagreb, Croatia
HUS Uusi lastensairaala
🇫🇮Helsinki, Finland
Centre Hospitalier Régional Universitaire d' Angers
🇫🇷ANGERS cedex 09, France
Centre Hospitalier Universitaire D'Angers-2
🇫🇷Angers, France
CHU Pellegrin
🇫🇷Bordeaux Cedex, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
🇫🇷Bordeaux, France
Ap-Hp-Hopital de Bicetre-1
🇫🇷Le Kremlin-Bicetre, France
Hopital de Bicetre_Le Kremlin-Bicetre
🇫🇷Le Kremlin-bicetre, France
Hopital de La Timone
🇫🇷MARSEILLE Cédex 05, France
Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
🇫🇷Marseille, France
Ap-Hp-Hopital Necker-2
🇫🇷Paris, France
Hôpital Necker
🇫🇷Paris, France
Hopital Des Enfants-1
🇫🇷Toulouse Cedex 9, France
CHU de Toulouse
🇫🇷Toulouse, France
Endokrinologikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Klinik für Allgemeine Pädiatrie und Neonatologie
🇩🇪Homburg, Germany
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
🇬🇷Athens, Greece
Childrens' Hospital of Athens "Agia Sofia"
🇬🇷Goudi/Athens, Greece
Amrita Institute Of Medical Sciences & Research Centre
🇮🇳Kochi, Kerala, India
Jehangir Clinical Development Centre
🇮🇳Pune, Maharashtra, India
All India Institute of Medical Sciences
🇮🇳New Dehli, New Delhi, India
Cork University Hospital
🇮🇪Cork, Ireland
Soroka Medical Center - Pediatric Endocrinology
🇮🇱Beer Sheva, Israel
Sheba Medical Center Pediatric Endocrinology
🇮🇱Tel Hashomer, Israel
Shamir (Assaf Harofe) Medical Center
🇮🇱Zerifin, Israel
IRCCS Meyer Firenze
🇮🇹Firenze, Italy
University Technology MARA (UiTM) - Puncak Alam
🇲🇾Bandar Puncak Alam Selangor Darul Ehsan, Malaysia
University Technology MARA (UiTM) - Sg Buloh
🇲🇾Bandar Puncak Alam Selangor Darul Ehsan, Malaysia
Consultorio de Endocrinología y Pediatría
🇲🇽Puebla, Mexico
Erasmus MC
🇳🇱Rotterdam, Netherlands
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
🇵🇱Rzeszow, Podkarpackie Voivodeship, Poland
Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie
🇵🇱Cracow, Poland
UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,
🇵🇱Gdansk, Poland
Klinika Endokrynologii i Chorób Metabolicznych
🇵🇱Lodz, Poland
SPSK nr 1 im Prof. T Sokolowskiego
🇵🇱Szczecin, Poland
Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1
🇵🇱Zabrze, Poland
SPSK nr 1 im. prof.S.Szyszko w Zabrzu
🇵🇱Zabrze, Poland
Centro Hospitalar Lisboa Central - Hospital Dona Estefânia
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa Norte
🇵🇹Lisboa, Portugal
Unidade Local De Saude De Santa Maria E.P.E.
🇵🇹Lisboa, Portugal
Unidade Local de Saúde de Santo António, E.P.E
🇵🇹Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
King Faisal Specialist Hospital & Research Centre, Riyadh
🇸🇦Riyadh, Saudi Arabia
National Guard Hospital
🇸🇦Riyadh, Saudi Arabia
University Clinical Centre Nis
🇷🇸Nis, Serbia
University Children's Hospital Tirsova
🇷🇸Belgrade, Serbia
Institute for Mother and Child Health Care of Serbia
🇷🇸Belgrade, Serbia
University Clinical Centre Kragujevac
🇷🇸Kragujevac, Serbia
Institute for Health Care of Children and Adolescents
🇷🇸Novi Sad, Serbia
PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism
🇸🇮Ljubljana, Slovenia
University Children's Hospital
🇸🇮Ljubljana, Slovenia
Department of Peadiatrics CHBAH
🇿🇦Johannesburg, Gauteng, South Africa
Dr JC van Dyk's Rooms
🇿🇦Pretoria, Gauteng, South Africa
Dr Y Ganie's site
🇿🇦Mayville, KwaZulu-Natal, South Africa
Dr K Pillay's site
🇿🇦Westville, KwaZulu-Natal, South Africa
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Madrid Montepríncipe
🇪🇸Boadilla del Monte, Madrid, Spain
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Spain
Med. Kinder- und Poliklinik
🇨🇭Bern, Switzerland
Ramathibodi Hospital - Ped-Endo and Metabolism
🇹🇭Ratchathewi, Bangkok, Thailand
King Chulalongkorn Memorial hospital-Ped-Endocrinology
🇹🇭Bangkok, Thailand
Phramongkutklao Hospital - Paediatrics Endocrinology Centre
🇹🇭Bangkok, Thailand
Siriraj Hospital_Bangkok_0
🇹🇭Bangkok, Thailand
Department of Pediatrics, Chiang Mai
🇹🇭Chiang Mai, Thailand
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Addenbrooke's Hospital_Cambridge
🇬🇧Cambridge, United Kingdom
Hull Royal Infirmary_Hull
🇬🇧Hull, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Evelina Children's Hospital - St Thomas'
🇬🇧London, United Kingdom
Evelina London Children's Hospital
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
St Georges Hospital
🇬🇧Tooting, United Kingdom