Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
NCT ID: NCT02616562
Last Updated: 2026-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2016-03-31
2024-09-26
Brief Summary
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The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort I Norditropin/somapacitan
Participants received Norditropin subcutaneously daily in main trial period, extension trial period and safety extension trial period. After completing the safety extension trial period (week 156), participants who received Norditropin were allocated to open-labelled Somapacitan dose 3 subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period. After week 364, participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Norditropin® FlexPro® pen
Administered subcutaneously (s.c., under the skin) once daily.
Cohort I somapacitan pooled
Participants were randomized (1:1:1) to receive Somapacitan treatment (dose 1/dose 2/dose 3) subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), all participants initially randomized to double-blinded Somapacitan received open-labelled Somapacitan dose 3 for the 104-week safety extension trial period. After completing the safety extension trial period (week 156), all participants in cohort I were allocated to open-labelled somapacitan dose 3 for the 208-week (up till week 364) long-term safety extension period. In extension after week 364 period participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.
somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Cohort II somapacitan previously treated
Participant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Cohort III somapacitan treatment naive
Participants who were naive to treatment with GH prior to enrolment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Cohort III somapacitan previously treated
Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.
somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Interventions
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somapacitan
Administered subcutaneously (s.c., under the skin) once-weekly.
Norditropin® FlexPro® pen
Administered subcutaneously (s.c., under the skin) once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
* Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
* No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
* Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
* Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months
Exclusion Criteria
* growth with standing measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
* Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
* Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
* Prior history or presence of malignancy and/or intracranial tumour
2 Years
10 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Mattel Children's Hospital at UCLA
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States
The Regents of the Univ of CA
San Diego, California, 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
The Endocrine Center
Pembroke Pines, Florida, United States
Childrens Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States
University of Minnesota_Minneapolis_2
Minneapolis, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Novo Nordisk Clinical Trial Call Center
Morristown, New Jersey, United States
Rutgers-Rwjms
New Brunswick, New Jersey, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
Novo Nordisk Clinical Trial Call Center
Mineola, New York, United States
NYU Langone Hospital-LI
Mineola, New York, United States
CCHMC_Cinc
Cincinnati, Ohio, United States
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States
University Of Oklahoma-Tulsa
Tulsa, Oklahoma, United States
Dell Pediatric Research Institute
Austin, Texas, United States
Endocrine Associates Of Dallas
Plano, Texas, United States
Children's Hsptl Of The Kings
Norfolk, Virginia, United States
MultiCare Inst for Res & Innov
Tacoma, Washington, United States
Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)
Linz, Upper Austria, Austria
Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie
Graz, , Austria
Graz, , Austria
LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde
Salzburg, , Austria
LKH St. Poelten, Kinder-und Jugendheilkunde
Sankt Pölten, , Austria
Landeskrankenhaus Villach
Villach, , Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, , Austria
UZ Brussel
Brussels, , Belgium
Brussels, , Belgium
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, , Belgium
UZ Leuven - Kindergeneeskunde
Leuven, , Belgium
CHU de Liège, site N.-D. des Bruyères
Liège, , Belgium
Serviço de Endocrinologia e Metabologia do HC-UFPR
Curitiba, Paraná, Brazil
Hospital São Lucas - PUC/RS
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
The Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire D'Angers-2
Angers, , France
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, , France
Bordeaux, , France
Centre Hospitalier Universitaire de Nantes-Hopital Enfant-Adolescent
Nantes, , France
Ap-Hp-Hopital Necker
Paris, , France
HOPITAL SUD de RENNES
Rennes, , France
HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie
Toulouse, , France
Frankfurt, , Germany
Endokrinologikum Frankfurt
Frankfurt am Main, , Germany
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, , Germany
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
New Dehli, New Delhi, India
Soroka MC - Pediatric Endocrinology
Beersheba, , Israel
Rambam MC - Department of Pediatrics A
Haifa, , Israel
Meir MC - Department of Paediatrics
Kfar Saba, , Israel
Kfar Saba, , Israel
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, , Israel
Sheba MC - Pediatric endocrinology and adolescent diabetes clinics
Tel Litwinsky, , Israel
Kyushu Univ. HP, Maternity & Perinatal Care Center
Fukuoka, , Japan
Kurume University Hospital, Pediatrics
Fukuoka, , Japan
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, , Japan
Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
Kyoto, , Japan
Osaka City General Hospital, Pediatric Endocrinology and Me
Osaka, , Japan
JCHO Osaka Hospital_Pediatric
Osaka, , Japan
Osaka Women's and Children's Hospital
Osaka, , Japan
Institute of Science Tokyo Hospital_Pediatrics
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
National Center for Child Health and Dev, Endo and Metabo
Tokyo, , Japan
Tokyo, , Japan
University Children's Hospital
Ljubljana, , Slovenia
Ljubljana, , Slovenia
Astrid Lindgrens Barnsjukhus
Stockholm, , Sweden
Stockholm, , Sweden
Barn och ungdomscentrum Västerbotten
Umeå, , Sweden
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
Adana, , Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi- Endokrinoloji
Ankara, , Turkey (Türkiye)
I.U Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, , Turkey (Türkiye)
Marmara Üniversitesi Pendik EAH- Başıbüyük Yerleşkesi- Kardiyoloji
Istanbul, , Turkey (Türkiye)
Ivano-Frankivsk Regional Clinical Children Hospital - Endocrinology dept.
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, , Ukraine
Countries
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References
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Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Rohrich S, Saenger P, Horikawa R. Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2569-2578. doi: 10.1210/clinem/dgad183.
Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Saenger P, Horikawa R. Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1357-1367. doi: 10.1210/clinem/dgab928.
Savendahl L, Battelino T, Brod M, Hojby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1847-61. doi: 10.1210/clinem/dgz310.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2015-000531-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1166-7062
Identifier Type: OTHER
Identifier Source: secondary_id
NN8640-4172
Identifier Type: -
Identifier Source: org_study_id
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