A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (REAL4)

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency in Children
• Intervention / Treatment: Drug: Somapacitan; Drug: Norditropin®

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria, 16000
    • CHU Bab El Oued Pediatrics Dept
  • Algiers, Algeria, 16000
    • Endo and Diab Dept El Oued
  • Constantine, Algeria, 25000
    • endocrino-diabetology department, Hospital IBN BADIS.
• Austria
  • Graz, Austria, 8036
    • Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie
  • Salzburg, Austria, A 5020
    • LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde
  • Sankt Pölten, Austria, 3100
    • LKH St. Poelten, Kinder-und Jugendheilkunde
  • Vöcklabruck, Austria, 4840
    • Salzkammergut-Klinikum Vöcklabruck
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Mntrl Chldrn Hsptl PedEndoMUHC
• Denmark
  • Copenhagen Ø, Denmark, 2100
    • Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064
• Estonia
  • Tallinn, Estonia, 13419
    • Tallinn Children's Hospital
  • Tartu, Estonia, 50406
    • Tartu University Hospital Children's Clinic
• France
  • Angers, France, 49100
    • Centre Hospitalier Universitaire D'Angers-2
  • Bordeaux, France, 33000
    • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
  • Le Kremlin-Bicêtre, France, 94270
    • Ap-Hp-Hopital de Bicetre-1
  • Le Kremlin-Bicêtre, France, 94275
    • Hopital de Bicetre_Le Kremlin-Bicetre
  • Marseille, France, 13005
    • Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
  • Marseille Cédex 05, France, 13385
    • Hopital de la Timone
  • Paris, France, 75015
    • Ap-Hp-Hopital Necker-2
  • Toulouse, France, 31059
    • HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie
• Germany
  • Frankfurt am Main, Germany, 60596
    • Endokrinologikum Frankfurt
  • Hanover, Germany, 30159
    • Auf der Bult Medizinisches Versorgungszentrum Hannover
  • Tübingen, Germany, 72076
    • Uniklinik Tübingen - Kinder- und Jugendmedizin
  • Ulm, Germany, 89075
    • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
• Hungary
  • Budapest, Hungary, 1023
    • Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Gyermekgyógyászati Klinika
• India
  • Kerala
    • Kochi, Kerala, India, 682041
      • Amrita Institute Of Medical Sciences & Research Centre
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Jehangir Clinical Development Centre
  • New Delhi
    • New Dehli, New Delhi, India, 110029
      • All India Institute of Medical Sciences
• Ireland
  • Dublin, Ireland, D12 N512
    • CHI Crumlin Dept of Endocrinology
• Israel
  • Haifa, Israel, 31096
    • Rambam MC - Department of Pediatrics A
  • Kfar Saba, Israel, 44281
    • Meir MC - Department of Paediatrics
  • Petah Tikva, Israel, 49202
    • Schneider MC - Endrocrinology and Diabetes
  • Ẕerifin, Israel, 7033001
    • Shamir MC - Pediatric and Adolescents Endocrinology unit
• Italy
  • Florence, Italy, 50139
    • IRCCS Meyer Firenze
  • Genova, Italy, 16147
    • Ospedale Pediatrico Gaslini
  • Milan, Italy, 20122
    • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
  • Roma, Italy, 00165
    • Ospedale Pediatrico Bambino Gesu
• Japan
  • Fukuoka, Japan, 830-0011
    • Kurume University Hospital, Pediatrics
  • Fukuoka-shi, Fukuoka, Japan, 813-0017
    • Fukuoka Children's Hospital_Endocrinology and Metabolism
  • Fukuyama-shi, Hiroshima, Japan, 720-8520
    • National Hospital Organization Fukuyama Medical Center
  • Fukuyama-shi, Hiroshima, Japan, 721-8511
    • Fukuyama City Hospital_Department of Pediatrics
  • Kanagawa, Japan, 232-8555
    • Kanagawa Children's Medical Center, Dev. Endo and Metabo
  • Kobe-shi, Hyogo, Japan, 650-0047
    • Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo
  • Kyoto, Japan, 602-8566
    • Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
  • Mito, Ibaraki, Japan, 311-4145
    • Ibaraki Children's Hospital_General Pediatrics
  • Nara-shi, Nara, Japan, 630-8581
    • Nara Prefecture General Medical Center_ Nara-shi, Nara
  • Niigata-shi, Niigata, Japan, 951 8520
    • Niigata University Medical & Dental Hospital_Pediatrics
  • Obu-shi, Aichi, Japan, 474-8710
    • Aichi Children's Health and Medical Center
  • Okayama-shi, Okayama, Japan, 701-1192
    • Okayama Medical Center_Cardiology
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital, Pediatric Endocrinology and Me
  • Osaka, Japan, 594-1101
    • Osaka Women's and Children's Hospital
  • Saitama-shi, Saitama, Japan, 330-8777
    • Saitama Children's Medical Center, Endocrinorogy&Metabolism
  • Shizuoka, Japan, 431-3192
    • Hamamatsu Univ. School of Medicine Hospital, Pediatrics
  • Suita-shi, Osaka, Japan, 565-0871
    • Osaka University Hospital_Pediatrics
  • Tokyo, Japan, 157 8535
    • National Center for Child Health and Dev, Endo and Metabo
  • Tokyo, Japan, 158-0097
    • Tanaka Growth Clinic
  • Tokyo, Japan, 113-8519
    • Institute of Science Tokyo Hospital_Pediatrics
  • Tokyo, Japan, 160-8582
    • Keio University Hospital, Pediatrics
  • Tokyo, Japan, 144-0034
    • KOUJIYA Kodomo Clinic
  • Tokyo, Japan, 183-8561
    • Tokyo Metropolitan Children's Medical Center_Endo and Metab
• Latvia
  • Riga, Latvia, 1004
    • Children's Clinical University Hospital
• Norway
  • Bergen, Norway, 5021
    • Haukeland Universitetssykehus, Barneklinikken
• Poland
  • Szczecin, Poland, 71-252
    • SPSK nr 1 im Prof. T Sokolowskiego
  • Warsaw, Poland, 04-730
    • Instytut ''Pomnik - Centrum Zdrowia Dziecka''
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-301
      • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
• Russia
  • Izhevsk, Russia, 426009
    • Republic Children's Hospital of Ministry of Health of Udmurt
  • Moscow, Russia, 119435
    • Setchenov First Moscow State Medical University
  • Moscow, Russia, 125373
    • RMAPE
  • Novosibirsk, Russia, 630048
    • Children's clinical city hospital #1
  • Rostov-on-Don, Russia, 344013
    • FSBEI of Higher Education "Rostov State Medical University"
  • Saint Petersburg, Russia, 191144
    • SPSBHI City Children out-patient clinic #44
  • Samara, Russia, 443079
    • Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
  • Tomsk, Russia, 634050
    • Siberian State Medical University
• Serbia
  • Belgrade, Serbia, 11000
    • University Children's Hospital Tirsova
  • Belgrade, Serbia, 11070
    • Institute for Mother and Child Health Care of Serbia
  • Kragujevac, Serbia, 34000
    • University Clinical Centre Kragujevac
  • Novi Sad, Serbia, 21000
    • Institute for Health Care of Children and Adolescents
  • RS
    • Niš, RS, Serbia, 18 000
      • University Clinical Centre Nis
• Slovenia
  • Ljubljana, Slovenia, 1525
    • University Children's Hospital
• South Korea
  • Busan, South Korea, 47392
    • Inje University Busan Paik Hospital
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, South Korea, 16499
    • Ajou University Hospital
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center_Seoul
  • Seoul, South Korea, 05355
    • Kangdong Sacred Heart Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
• Spain
  • Esplugues Llobregat(Barcelona), Spain, 08950
    • Hospital Sant Joan de Déu
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clínico de Santiago de Compostela
• Switzerland
  • Basel, Switzerland, 4031
    • Universitäts-Kinderspital beider Basel
  • Bern, Switzerland, 3010
    • Med. Kinder- und Poliklinik
  • Zurich, Switzerland, 8032
    • Kinderspital Endokrinologie, Zürich
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial hospital_Ped-Endocrinology
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital_Ped-Endo_Pediatrics
• Ukraine
  • Kharkiv, Ukraine, 61093
    • Kharkiv Regional Children's Clinical Hospital - Endocrinological department
  • Kyiv, Ukraine, 04114
    • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
  • Vinnytsia, Ukraine, 21010
    • Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital_Cambridge
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • Liverpool, United Kingdom, L12 2AP
    • Alder Hey Children's Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital_London
  • Manchester, United Kingdom, M13 9WL
    • Royal Manchester Children's Hospital
  • Tooting, United Kingdom, SW17 0RE
    • St Georges Hospital
  • Tooting, United Kingdom, SW17 0RE
    • St George's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ of AL at Birmingham_BRM
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles - Endocrinology
    • Madera, California, United States, 93636-8762
      • Valley Children's Hospital
    • Orange, California, United States, 92868
      • Children's Hosp Of Orange
    • Sacramento, California, United States, 95821
      • Sutter Valley Med Fdt Ped Endo
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Rocky Mt Ped and Endo
    • Greenwood Village, Colorado, United States, 80111-2803
      • Ped Endo Assoc PC-G.V
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale-New Haven Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • A.I. duPont Hospital for Children/Nemours
  • Florida
    • Aventura, Florida, United States, 33180
      • Pediatric Endocrine & Wellness Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Van Meter Pediatric Endo PC
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Univ of Minnesota M.C.H.
    • Saint Paul, Minnesota, United States, 55102
      • Children's Minnesota
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy Clinics
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • The Docs
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Goryeb Children's Hospital
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Peds-Div of Endo/Diabetes
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital-LI
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Childn Endo-Dbt_Raleig
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • CCHMC_Cinc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Univ Oklahoma Sci Ctr OK City
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Child Hosp-Pittsburgh
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Inst for Res & Innov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
• Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
• Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
• Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
• Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
• No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion Criteria:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
• 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 of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
• Diagnosis of attention deficit hyperactivity disorder
• 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
• Prior history or presence of malignancy including intracranial tumours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somapacitan weekly; Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).	Drug: Somapacitan; Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
Active Comparator: Norditropin® daily; Participants will receive Norditropin® daily for 52 weeks (main trial period).	Drug: Norditropin®; Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height Velocity: In-trial Observation Period	Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	From baseline (week 0) to visit 7 (week 52)
Height Velocity: On-treatment Observation Period	Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.	From baseline (week 0) to visit 7 (week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone Age	Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week -2), week 52
Change in Height Standard Deviation Score (HSDS)	Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week 0), week 52
Change in Height Velocity Standard Deviation Score (HV SDS)	Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week 0), week 52
Change in Fasting Plasma Glucose (FPG) at Week 52	Change from baseline (week -2) in FPG at week 52 is presented.	Baseline (week -2), week 52
Change in FPG at Week 104		Baseline (week -2), week 104
Change in FPG at Week 156		Baseline (week -2), week 156
Change in FPG at Week 208		Baseline (week -2), week 208
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52	Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.	Baseline (week -2), week 52
Change in HOMA-B at Week 104		Baseline (week -2), week 104
Change in HOMA-B at Week 156		Baseline (week -2), week 156
Change in HOMA-B at Week 208		Baseline (week -2), week 208
Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52	Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.	Baseline (week -2), week 52
Change in HOMA-IR at Week 104		Baseline (week -2), week 104
Change in HOMA-IR at Week 156		Baseline (week -2), week 156
Change in HOMA-IR at Week 208		Baseline (week -2), week 208
Change in Glycated Haemoglobin (HbA1c) at Week 52	Change from baseline (week -2) in HbA1c at week 52 is presented.	Baseline (week -2), week 52
Change in HbA1c at Week 104		Baseline (week -2), week 104
Change in HbA1c at Week 156		Baseline (week -2), week 156
Change in HbA1c at Week 208		Baseline (week -2), week 208
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52	Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week 0), week 52
Change in IGF-I SDS at Week 104		Baseline (week 0), week 104
Change in IGF-I SDS at Week 156		Baseline (week 0), week 156
Change in IGF-I SDS at Week 208		Baseline (week 0), week 208
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52	Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.	Baseline (week 0), week 52
Change in IGFBP-3 SDS at Week 104		Baseline (week 0), week 104
Change in IGFBP-3 SDS at Week 156		Baseline (week 0), week 156
Change in IGFBP-3 SDS at Week 208		Baseline (week 0), week 208

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

General Publications

• Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Bottcher V, Stagi S, Horikawa R. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3378-3388. doi: 10.1210/clinem/dgac513.
• Miller BS, Blair JC, Rasmussen MH, Frystyk J, Lemminger AK, Maniatis A, Mori J, Bottcher V, Kim HS, Polak M, Horikawa R. Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4. Eur J Endocrinol. 2025 Apr 30;192(5):651-661. doi: 10.1093/ejendo/lvaf096.
• Mori J, Ohata Y, Fujisawa Y, Sato Y, Rohrich S, Rasmussen MH, Bang RB, Horikawa R. Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial. Clin Endocrinol (Oxf). 2024 Apr;100(4):389-398. doi: 10.1111/cen.15025. Epub 2024 Feb 18.
• Miller BS, Blair JC, Rasmussen MH, Maniatis A, Mori J, Bottcher V, Kim HS, Bang RB, Polak M, Horikawa R. Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH. J Clin Endocrinol Metab. 2023 Nov 17;108(12):3090-3099. doi: 10.1210/clinem/dgad394.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Bone Diseases, Endocrine; Bone Diseases, Developmental; Dwarfism; Hypopituitarism; Dwarfism, Pituitary; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormones; Growth Hormone; Pituitary Hormones, Anterior; somapacitan; Human Growth Hormone
• Other Study ID Numbers: NN8640-4263; U1111-1207-9691 (Other Identifier: World Health Organization (WHO)); 2018-000231-27 (Other Identifier: European Medicines Agency (EudraCT)); JapicCTI-194773 (Registry Identifier: JAPIC (Japan))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No