A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

NCT03878446 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: NN8640-4245U1111-1207-97412018-000232-10
• Study Type: interventional
• Target: 62
• Locations: 22 countries
• Sites: 90

Brief Summary

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.

Conditions

Short Stature Children Born Small for Gestational Age (SGA)

Outcome Measures

Primary Outcomes (1)

• Height Velocity

  Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.

  Baseline (week 0); week 26

Secondary Outcomes (9)

• Change in Ratio of Bone Age Versus Chronological Age

  Baseline (week 0); week 52

• Change in Height Standard Deviation Score (HSDS)

  Baseline (week 0); week 26

• Change in Height Velocity Standard Deviation Score (HVSDS)

  Baseline (week 0); week 26

• Change in Fasting Plasma Glucose

  Baseline (week 0); week 26

• Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B)

  Baseline (week 0); week 26

Study Arms (5)

Somapacitan 0.24 mg/kg/week

EXPERIMENTAL

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan

Somapacitan 0.20 mg/kg/week

EXPERIMENTAL

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan

Somapacitan 0.16 mg/kg/week

EXPERIMENTAL

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan

Norditropin® 0.035 mg/kg/day

ACTIVE COMPARATOR

Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Norditropin®

Norditropin® 0.067 mg/kg/day

ACTIVE COMPARATOR

Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Norditropin®

Interventions

Somapacitan DRUG

Somapacitan injected under the skin once a week.

Somapacitan 0.16 mg/kg/week; Somapacitan 0.20 mg/kg/week; Somapacitan 0.24 mg/kg/week

Norditropin® DRUG

Norditropin® injected under the skin once a day.

Norditropin® 0.035 mg/kg/day; Norditropin® 0.067 mg/kg/day

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pre-pubertal children, boys:
• age between 2.5 and 11.0 years at screening.
• testes volume below 4 ml.
• Pre-pubertal children, girls:
• age between 2.5 and 10.0 years at screening.
• Tanner stage 1 for breast development (no palpable glandular breast tissue).
• Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
• Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
• Impaired height velocity defined as annualized height velocity below the 50th 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.
• No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

You may not qualify if:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
• Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
• 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.
• 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.
• Diagnosis of attention deficit hyperactivity disorder.
• Prior history or presence of malignancy including intracranial tumours.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (92)

Univ of AL at Birmingham_BRM

Birmingham, Alabama, 35233, United States

Location

Children's Hosp Of Orange

Orange, California, 92868, United States

Location

St. Luke's Children's Endo

Boise, Idaho, 83712, United States

Location

Univ of Minnesota M.C.H.

Minneapolis, Minnesota, 55454, United States

Location

Children's Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Goryeb Children's Hospital

Morristown, New Jersey, 07962, United States

Location

Rutgers-Rwjms

New Brunswick, New Jersey, 08901, United States

Location

NYU Langone Hospital-LI

Garden City, New York, 11530, United States

Location

NYU Langone Hospital-LI

Mineola, New York, 11501, United States

Location

Icahn Sch of Med-Mt Sinai Hosp

New York, New York, 10029, United States

Location

CCHMC_Cinc

Cincinnati, Ohio, 45229, United States

Location

Univ Oklahoma Sci Ctr OK City

Oklahoma City, Oklahoma, 73104, United States

Location

Cook Children's Hospital-Hematology-Oncology

Fort Worth, Texas, 76104, United States

Location

MultiCare Inst for Res & Innov

Tacoma, Washington, 98405, United States

Location

CHU Bab El Oued Pediatrics Dept

Algiers, 16000, Algeria

Location

Endo and Diab Dept El Oued

Algiers, 16000, Algeria

Location

endocrino-diabetology department, Hospital IBN BADIS.

Constantine, 25000, Algeria

Location

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

Linz, Upper Austria, 4020, Austria

Location

Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie

Graz, 8036, Austria

Location

LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde

Salzburg, A 5020, Austria

Location

LKH St. Poelten, Kinder-und Jugendheilkunde

Sankt Pölten, 3100, Austria

Location

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, 4840, Austria

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064

Copenhagen Ø, 2100, Denmark

Location

Tallinn Children's Hospital

Tallinn, 13419, Estonia

Location

Tartu University Hospital Children's Clinic

Tartu, 50406, Estonia

Location

Centre Hospitalier Universitaire D'Angers-2

Angers, 49100, France

Location

Ap-Hp-Hopital de Bicetre-2

Le Kremlin-Bicêtre, 94270, France

Location

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

Marseille, 13005, France

Location

Hopital de La Timone

Marseille Cédex 05, 13385, France

Location

Ap-Hp-Hopital Necker-2

Paris, 75015, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hopital Des Enfants-2

Toulouse, 31059, France

Location

Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő

Budapest, 1023, Hungary

Location

Szegedi Tudományegyetem Gyermekgyógyászati Klinika

Szeged, 6720, Hungary

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Jehangir Clinical Development Centre

Pune, Maharashtra, 411001, India

Location

All India Institute of Medical Sciences

New Dehli, New Delhi, 110029, India

Location

CHI Crumlin Dept of Endocrinology

Dublin, D12 N512, Ireland

Location

Rambam MC - Department of Pediatrics A

Haifa, 31096, Israel

Location

Meir MC - Department of Paediatrics

Kfar Saba, 44281, Israel

Location

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, 49202, Israel

Location

IRCCS Meyer Firenze

Florence, 50139, Italy

Location

Ospedale Pediatrico Gaslini

Genova, 16147, Italy

Location

Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia

Milan, 20122, Italy

Location

Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

Kurume University Hospital, Pediatrics

Fukuoka, 830-0011, Japan

Location

Fukuoka Children's Hospital_Endocrinology and Metabolism

Fukuoka-shi, Fukuoka, 813-0017, Japan

Location

Fukuoka Children's Hospital

Fukuoka-shi, Fukuoka, 813-0017, Japan

Location

Fukuyama City Hospital_Department of Pediatrics

Fukuyama-shi, Hiroshima, 721-8511, Japan

Location

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

Kobe-shi, Hyogo, 650-0047, Japan

Location

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

Kyoto, 602-8566, Japan

Location

Nara Prefecture General Medical Center_ Nara-shi, Nara

Nara-shi, Nara, 630-8581, Japan

Location

Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, 951 8520, Japan

Location

Osaka City General Hospital, Pediatric Endocrinology and Me

Osaka, 534-0021, Japan

Location

Osaka Women's and Children's Hospital

Osaka, 594-1101, Japan

Location

Saitama Children's Medical Center, Endocrinorogy&Metabolism

Saitama-shi, Saitama, 330-8777, Japan

Location

Institute of Science Tokyo Hospital_Pediatrics

Tokyo, 113-8519, Japan

Location

Institute of Science Tokyo Hospital

Tokyo, 113-8519, Japan

Location

National Center for Child Health and Dev, Endo and Metabo

Tokyo, 157 8535, Japan

Location

Keio University Hospital, Pediatrics

Tokyo, 160-8582, Japan

Location

Children's Clinical University Hospital

Riga, 1004, Latvia

Location

Haukeland Universitetssykehus, Barneklinikken

Bergen, 5021, Norway

Location

SPSK nr 1 im Prof. T Sokolowskiego

Szczecin, 71-252, Poland

Location

Instytut ''Pomnik - Centrum Zdrowia Dziecka''

Warsaw, 04-730, Poland

Location

Republic Children's Hospital of Ministry of Health of Udmurt

Izhevsk, 426009, Russia

Location

Setchenov First Moscow State Medical University

Moscow, 119435, Russia

Location

RMAPE

Moscow, 125373, Russia

Location

Children's clinical city hospital #1

Novosibirsk, 630048, Russia

Location

FSBEI of Higher Education "Rostov State Medical University"

Rostov-on-Don, 344013, Russia

Location

SPSBHI City Children out-patient clinic #44

Saint Petersburg, 191144, Russia

Location

Samara Regional Children Clinical Hospital n.a. N.N. Ivanova

Samara, 443079, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

University Children's Hospital Tirsova

Belgrade, 11000, Serbia

Location

Institute for Mother and Child Health Care of Serbia

Belgrade, 11070, Serbia

Location

University Clinical Centre Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Center in Nis

Niš, 18 000, Serbia

Location

Institute for Health Care of Children and Adolescents

Novi Sad, 21000, Serbia

Location

Hospital Sant Joan de Déu

Esplugues Llobregat(Barcelona), 08950, Spain

Location

Hospital Clínico de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Med. Kinder- und Poliklinik

Bern, 3010, Switzerland

Location

Kinderspital Endokrinologie, Zürich

Zurich, 8032, Switzerland

Location

King Chulalongkorn Memorial hospital-Ped-Endocrinology

Bangkok, 10330, Thailand

Location

King Chulalongkorn Memorial hospital_Ped-Endocrinology

Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital_Ped-Endo_Pediatrics

Bangkok, 10400, Thailand

Location

Dnipropetrovsk Regional Children's Clinical Hospital - Endocrinology department

Dnipro, 49100, Ukraine

Location

Kharkiv Regional Children's Clinical Hospital - Endocrinological department

Kharkiv, 61093, Ukraine

Location

Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology

Kyiv, 04114, Ukraine

Location

Hull Royal Infirmary_Hull

Hull, HU3 2JZ, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L12 2AP, United Kingdom

Location

Royal London Hospital_London

London, E1 1BB, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Juul A, Hojby M, Kawai M, Linglart A, Mori J, Zuckerman-Levin N, Backeljauw P. Somapacitan in children born small for gestational age: 4-year results from phase 2. Eur J Endocrinol. 2026 Feb 4;194(2):157-169. doi: 10.1093/ejendo/lvag017.

  PMID: 41614610 DERIVED

MeSH Terms

Interventions

somapacitan; Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: July 4, 2019
• Primary Completion: May 5, 2021
• Study Completion (Estimated): December 23, 2026
• Last Updated: December 23, 2025
• Results First Posted: June 20, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IE (1); HU (2); AU (5); LA (1); CH (2); NO (1); TH (3); ES (2); JP (15); IT (4); SE (5); PL (2); US (14); CA (1); IN (3); AL (3); IL (3); RU (8); DK (1); GB (4); FR (7); UA (3)