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ACTIVE NOT RECRUITING
NCT05330325
PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2022-08-10

Completion Date

2027-10-29

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Somapacitan

Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

DRUG

Norditropin®

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

Locations (199)

Univ of AL at Birmingham_BRM

Birmingham, Alabama, United States

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

Rocky Mt Ped and Endo

Centennial, 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 D.C., 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

UMass Medical School

Worcester, Massachusetts, 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

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, United States

NYU Langone Hospital-LI

Garden City, New York, United States

NYU Langone Hospital-LI

Mineola, New York, United States

WakeMed Childn Endo-Dbt_Raleig

Raleigh, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

CCHMC_Cinc

Cincinnati, Ohio, United States

Univ Oklahoma Sci Ctr OK City

Oklahoma City, Oklahoma, United States

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, United States

UT Southwestern Med Cntr

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

University Of Virginia Hospitl

Charlottesville, Virginia, United States

MultiCare Inst for Res & Innov

Tacoma, Washington, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

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

Linz, Upper Austria, Austria

Krankenhaus der Stadt Dornbirn

Dornbirn, Austria

LKH St. Poelten, Kinder-und Jugendheilkunde

Sankt Pölten, Austria

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, Austria

UZ Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

Brussels, Belgium

UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, Belgium

UZ Leuven - Kindergeneeskunde

Leuven, Belgium

Centro de Diabetes Curitiba

Curitiba, Paraná, Brazil

Santa Casa Sao Paulo

São Paulo, São Paulo, Brazil

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

UMHAT - Dr. Georgi Stranski EAD

Pleven, Bulgaria

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics

Plovdiv, Bulgaria

SHATPD - Prof. Ivan Mitev EAD

Sofia, Bulgaria

UMHAT Sveta Marina EAD, First Pediatric Clinic

Varna, Bulgaria

Children's Hosp-East Ontario

Ottawa, Ontario, Canada

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou Maternity and Child Healthcare Hospital-Child Healthcare

Liuchow, Guangxi, 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 Center

Changsha, Hunan, China

The First Bethune Hospital of Jilin University-Pediatric

Changchun, Jilin, China

Shandong Provincial Hospital-Pediatric

Jinan, Shandong, China

Shanghai Children's Hospital -Endocrine Genetics and Metabolism

Shanghai, Shanghai Municipality, China

Shanghai Children's Medical Center-Endocrine Genetics and Metabolism

Shanghai, Shanghai Municipality, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

KBC "Sestre Milosrdnice"

Zagreb, Croatia

KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

Zagreb, Croatia

HUS Pediatric Unit

Helsinki, Finland

Centre Hospitalier Régional Universitaire d' Angers

Angers, France

Centre Hospitalier Universitaire D'Angers-2

Angers, France

Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

Bordeaux, France

CHU Pellegrin

Bordeaux, France

Ap-Hp-Hopital de Bicetre

Le Kremlin-Bicêtre, France

Hopital de Bicetre_Le Kremlin-Bicetre

Le Kremlin-Bicêtre, France

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

Marseille, France

Hopital de La Timone

Marseille Cédex 05, France

Ap-Hp-Hopital Necker

Paris, France

Hôpital Necker

Paris, France

CHU de Toulouse

Toulouse, France

Hopital Des Enfants

Toulouse, France

Universitätsklinikum Bonn - Kinderklinik

Bonn, Germany

Universitätsklinikum Erlangen - Kinder- und Jugendklinik

Erlangen, Germany

Endokrinologikum Frankfurt

Frankfurt am Main, Germany

Klinik für Allgemeine Pädiatrie und Neonatologie

Homburg, Germany

Universität des Saarlandes - Pädiatrie und Neonatologie

Homburg, Germany

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

Athens, Greece

Childrens' Hospital of Athens "Agia Sofia"

Goudi/Athens, Greece

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

Goudi/Athens, Greece

General University of Patra - Paediatric Department

Pátrai, 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

Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

Thessaloniki, Greece

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, 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

CHI at Temple Street

Dublin, Ireland

CHI Crumlin Dept of Endocrinology

Dublin, Ireland

CHI Tallaght University Hospital

Dublin, Ireland

Soroka MC - Pediatric Endocrinology

Beersheba, Israel

Rambam MC - Department of Pediatrics A

Haifa, Israel

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, Israel

Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

Tel Litwinsky, Israel

Shamir MC - Pediatric and Adolescents Endocrinology unit

Ẕerifin, Israel

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

Milan, Lombardy, Italy

IRCCS Meyer Firenze

Florence, Italy

Ospedale Pediatrico Gaslini

Genova, Italy

Ospedale San Raffaele UO di Pediatria e UO di Neonatologia

Milan, Italy

Università degli Studi della Campania "L. Vanvitelli"

Naples, Italy

Bambin Gesù

Roma, Italy

Ospedale Pediatrico Bambino Gesu

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCS

Rome, Italy

Fukuoka Children's Hospital_Endocrinology and Metabolism

Fukuoka-shi, Fukuoka, Japan

Fukuoka Children's Hospital

Fukuoka-shi, Fukuoka, Japan

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

Kobe-shi, Hyogo, Japan

Hyogo Prefectual Kobe Children's Hospital_Metab & endo

Kobe-shi, Hyogo, Japan

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

Kyoto, Japan

Nara Prefecture General Medical Center_Nephrology

Nara-shi, Nara, Japan

Nara Prefecture General Medical Center

Nara-shi, Nara, Japan

Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, Japan

Okayama Medical Center_Cardiology

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

Hokkaido University Hospital_Pediatrics

Sapporo, Hokkaido, Japan

Shizuoka Children's Hospital, Department of Diabetes and metabolism

Shizuoka-shi, Shizuoka, Japan

Institute of Science Tokyo Hospital_Pediatrics

Tokyo, Japan

Institute of Science Tokyo Hospital

Tokyo, Japan

National Center for Child Health and Development_Endo and Metabo

Tokyo, Japan

Keio University Hospital_Pediatrics

Tokyo, Japan

Fujita Health University Hospital, Pediatrics

Toyoake, Aichi, Japan

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, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

Hospital Al-Sultan Abdullah UiTM

Bandar Puncak Alam, Selangor, Malaysia

University Technology MARA (UiTM) - Puncak Alam

Bandar Puncak Alam Selangor Darul Ehsan, Malaysia

Consultorio de Endocrinología y Pediatría

Puebla City, Mexico

Erasmus MC

Rotterdam, Netherlands

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

Rzeszów, Podkarpackie Voivodeship, Poland

UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,

Gdansk, Poland

Górnośląskie Centrum Zdrowia Dziecka Szpital Kliniczny Nr 6

Katowice, Poland

Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie

Krakow, Poland

Uniwersytecki Szptal Dziecięcy w Krakowie

Krakow, 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

Unidade Local De Saúde De São José, E.P.E.- Hospital D. Estefânia

Lisbon, Portugal

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Unidade Local De Saúde De Santa Maria E.P.E.

Lisbon, 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

Niš, RS, 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

University Clinical Centre Nis

Niš, 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

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Chungnam National University Sejong Hospital

Sejong-si, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

H.Madrid Montepríncipe

Boadilla del Monte, Madrid, 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

Ramathibodi Hospital - Ped-Endo and Metabolism

Bangkok, Ratchathewi, Thailand

King Chulalongkorn Memorial hospital-Ped-Endocrinology

Bangkok, Thailand

King Chulalongkorn Memorial hospital_Ped-Endocrinology

Bangkok, Thailand

Phramongkutklao Hospital_Ped-Endo_Pediatrics

Bangkok, Thailand

PMK - Paediatrics Endocrinology Centre

Bangkok, Thailand

Siriraj Hospital_Dept of Paediatrics

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

Chiang Mai, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Addenbrooke's Hospital_Cambridge

Cambridge, United Kingdom

Hull Royal Infirmary

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 George's Hospital

Tooting, United Kingdom

St Georges Hospital

Tooting, United Kingdom