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

NCT ID: NCT03878446

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2026-12-23

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somapacitan 0.24 mg/kg/week

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.

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

Somapacitan injected under the skin once a week.

Somapacitan 0.20 mg/kg/week

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.

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

Somapacitan injected under the skin once a week.

Somapacitan 0.16 mg/kg/week

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.

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

Somapacitan injected under the skin once a week.

Norditropin® 0.035 mg/kg/day

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.

Group Type: ACTIVE_COMPARATOR

Norditropin®

Intervention Type: DRUG

Norditropin® injected under the skin once a day.

Norditropin® 0.067 mg/kg/day

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.

Group Type: ACTIVE_COMPARATOR

Norditropin®

Intervention Type: DRUG

Norditropin® injected under the skin once a day.

Interventions

Somapacitan

Somapacitan injected under the skin once a week.

Intervention Type: DRUG

Norditropin®

Norditropin® injected under the skin once a day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pre-pubertal children, boys:

1. age between 2.5 and 11.0 years at screening.

2. testes volume below 4 ml.

• Pre-pubertal children, girls:

1. age between 2.5 and 10.0 years at screening.

2. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Univ of AL at Birmingham_BRM

Birmingham, Alabama, United States

Children's Hosp Of Orange

Orange, California, United States

St. Luke's Children's Endo

Boise, Idaho, United States

Univ of Minnesota M.C.H.

Minneapolis, Minnesota, United States

Children's Minnesota

Saint Paul, Minnesota, United States

Goryeb Children's Hospital

Morristown, New Jersey, United States

Rutgers-Rwjms

New Brunswick, New Jersey, United States

NYU Langone Hospital-LI

Garden City, New York, United States

NYU Langone Hospital-LI

Mineola, New York, United States

Icahn Sch of Med-Mt Sinai Hosp

New York, New York, United States

CCHMC_Cinc

Cincinnati, Ohio, United States

Univ Oklahoma Sci Ctr OK City

Oklahoma City, Oklahoma, United States

Cook Children's Hospital-Hematology-Oncology

Fort Worth, Texas, United States

MultiCare Inst for Res & Innov

Tacoma, Washington, United States

CHU Bab El Oued Pediatrics Dept

Algiers, , Algeria

Endo and Diab Dept El Oued

Algiers, , Algeria

endocrino-diabetology department, Hospital IBN BADIS.

Constantine, , Algeria

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

Linz, Upper Austria, Austria

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

Graz, , Austria

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

Salzburg, , Austria

LKH St. Poelten, Kinder-und Jugendheilkunde

Sankt Pölten, , Austria

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, , Austria

Stollery Children's Hospital

Edmonton, Alberta, Canada

Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064

Copenhagen Ø, , Denmark

Tallinn Children's Hospital

Tallinn, , Estonia

Tartu University Hospital Children's Clinic

Tartu, , Estonia

Centre Hospitalier Universitaire D'Angers-2

Angers, , France

Ap-Hp-Hopital de Bicetre-2

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-2

Paris, , France

Hôpital Necker

Paris, , France

Hopital Des Enfants-2

Toulouse, , France

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

Budapest, , Hungary

Szegedi Tudományegyetem Gyermekgyógyászati Klinika

Szeged, , Hungary

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

CHI Crumlin Dept of Endocrinology

Dublin, , Ireland

Rambam MC - Department of Pediatrics A

Haifa, , Israel

Meir MC - Department of Paediatrics

Kfar Saba, , Israel

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, , Israel

IRCCS Meyer Firenze

Florence, , Italy

Ospedale Pediatrico Gaslini

Genova, , Italy

Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia

Milan, , Italy

Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Kurume University Hospital, Pediatrics

Fukuoka, , Japan

Fukuoka Children's Hospital_Endocrinology and Metabolism

Fukuoka-shi, Fukuoka, , Japan

Fukuoka Children's Hospital

Fukuoka-shi, Fukuoka, , Japan

Fukuyama City Hospital_Department of Pediatrics

Fukuyama-shi, Hiroshima, , Japan

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

Kobe-shi, Hyogo, , Japan

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

Kyoto, , Japan

Nara Prefecture General Medical Center_ Nara-shi, Nara

Nara-shi, Nara, , Japan

Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, , 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

Institute of Science Tokyo Hospital_Pediatrics

Tokyo, , Japan

Institute of Science Tokyo Hospital

Tokyo, , Japan

National Center for Child Health and Dev, Endo and Metabo

Tokyo, , Japan

Keio University Hospital, Pediatrics

Tokyo, , Japan

Children's Clinical University Hospital

Riga, , Latvia

Haukeland Universitetssykehus, Barneklinikken

Bergen, , Norway

SPSK nr 1 im Prof. T Sokolowskiego

Szczecin, , Poland

Instytut ''Pomnik - Centrum Zdrowia Dziecka''

Warsaw, , Poland

Republic Children's Hospital of Ministry of Health of Udmurt

Izhevsk, , Russia

Setchenov First Moscow State Medical University

Moscow, , Russia

RMAPE

Moscow, , Russia

Children's clinical city hospital #1

Novosibirsk, , Russia

FSBEI of Higher Education "Rostov State Medical University"

Rostov-on-Don, , Russia

SPSBHI City Children out-patient clinic #44

Saint Petersburg, , Russia

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

Samara, , Russia

Siberian State Medical University

Tomsk, , Russia

University Children's Hospital Tirsova

Belgrade, , Serbia

Institute for Mother and Child Health Care of Serbia

Belgrade, , Serbia

University Clinical Centre Kragujevac

Kragujevac, , Serbia

Clinical Center in Nis

Niš, , Serbia

Institute for Health Care of Children and Adolescents

Novi Sad, , Serbia

Hospital Sant Joan de Déu

Esplugues Llobregat(Barcelona), , Spain

Hospital Clínico de Santiago de Compostela

Santiago de Compostela, , Spain

Med. Kinder- und Poliklinik

Bern, , Switzerland

Kinderspital Endokrinologie, Zürich

Zurich, , Switzerland

King Chulalongkorn Memorial hospital-Ped-Endocrinology

Bangkok, , Thailand

King Chulalongkorn Memorial hospital_Ped-Endocrinology

Bangkok, , Thailand

Phramongkutklao Hospital_Ped-Endo_Pediatrics

Bangkok, , Thailand

Dnipropetrovsk Regional Children's Clinical Hospital - Endocrinology department

Dnipro, , Ukraine

Kharkiv Regional Children's Clinical Hospital - Endocrinological department

Kharkiv, , Ukraine

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

Kyiv, , Ukraine

Hull Royal Infirmary_Hull

Hull, , United Kingdom

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Royal London Hospital_London

London, , United Kingdom

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Countries

United States; Algeria; Austria; Canada; Denmark; Estonia; France; Hungary; India; Ireland; Israel; Italy; Japan; Latvia; Norway; Poland; Russia; Serbia; Spain; Switzerland; Thailand; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-000232-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1207-9741

Identifier Type: OTHER

Identifier Source: secondary_id

NN8640-4245

Identifier Type: -

Identifier Source: org_study_id