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Weekly shot may replace daily needles for short stature kids

NCT ID NCT03878446

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests a new once-weekly growth hormone medicine (somapacitan) against a daily one (Norditropin) in 62 children born small who remain short. The goal is to see if the weekly shot works as well and is safe. Children receive injections either once a week or once a day for up to 5 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

62 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Short stature children born small for gestational age (SGA)

Contacts and locations

Locations

  • AP-HP-HOPITAL DE BICETRE_Service d'Endocrinologie pédiatrique

    Le Kremlin-Bicêtre, 94270, France

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP, United Kingdom

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029, India

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041, India

  • Ap-Hp-Hopital Necker

    Paris, 75015, France

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

    Marseille, 13005, France

  • CCHMC_Cinc

    Cincinnati, Ohio, 45229, United States

  • CHI Crumlin Dept of Endocrinology

    Dublin, D12 N512, Ireland

  • CHU Bab El Oued Pediatrics Dept

    Algiers, 16000, Algeria

  • Centre Hospitalier Universitaire D'Angers-2

    Angers, 49100, France

  • Children's Clinical University Hospital

    Riga, 1004, Latvia

  • Children's Hosp Of Orange

    Orange, California, 92868, United States

  • Children's Minnesota

    Saint Paul, Minnesota, 55102, United States

  • Children's clinical city hospital #1

    Novosibirsk, 630048, Russia

  • Clinical Center in Nis

    Niš, 18 000, Serbia

  • Cook Children's Hospital-Hematology-Oncology

    Fort Worth, Texas, 76104, United States

  • Dnipropetrovsk Regional Children's Clinical Hospital - Endocrinology department

    Dnipro, 49100, Ukraine

  • Endo and Diab Dept El Oued

    Algiers, 16000, Algeria

  • FSBEI of Higher Education "Rostov State Medical University"

    Rostov-on-Don, 344013, Russia

  • Fukuoka Children's Hospital

    Fukuoka-shi, Fukuoka, 813-0017, Japan

  • Fukuoka Children's Hospital_Endocrinology and Metabolism

    Fukuoka-shi, Fukuoka, 813-0017, Japan

  • Fukuyama City Hospital_Department of Pediatrics

    Fukuyama-shi, Hiroshima, 721-8511, Japan

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07962, United States

  • HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie

    Toulouse, 31059, France

  • Haukeland Universitetssykehus, Barneklinikken

    Bergen, 5021, Norway

  • Hopital de La Timone

    Marseille Cédex 05, 13385, France

  • Hospital Clínico de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital Sant Joan de Déu

    Esplugues Llobregat(Barcelona), 08950, Spain

  • Hull Royal Infirmary

    Hull, HU3 2JZ, United Kingdom

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

    Kobe-shi, Hyogo, 650-0047, Japan

  • Hyogo Prefectual Kobe Children's Hospital_Metab & endo

    Kobe-shi, Hyogo, 650-0047, Japan

  • Hôpital Necker

    Paris, 75015, France

  • IRCCS Meyer Firenze

    Florence, 50139, Italy

  • Icahn Sch of Med-Mt Sinai Hosp

    New York, New York, 10029, United States

  • Institute for Health Care of Children and Adolescents

    Novi Sad, 21000, Serbia

  • Institute for Mother and Child Health Care of Serbia

    Belgrade, 11070, Serbia

  • Institute of Science Tokyo Hospital

    Tokyo, 113-8519, Japan

  • Institute of Science Tokyo Hospital_Pediatrics

    Tokyo, 113-8519, Japan

  • Instytut ''Pomnik - Centrum Zdrowia Dziecka''

    Warsaw, 04-730, Poland

  • Jehangir Clinical Development Centre

    Pune, Maharashtra, 411001, India

  • Keio University Hospital_Pediatrics

    Tokyo, 160-8582, Japan

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

    Linz, Upper Austria, 4020, Austria

  • Kharkiv Regional Children's Clinical Hospital - Endocrinological department

    Kharkiv, 61093, Ukraine

  • Kinderspital Endokrinologie, Zürich

    Zurich, 8032, Switzerland

  • King Chulalongkorn Memorial hospital-Ped-Endocrinology

    Bangkok, 10330, Thailand

  • King Chulalongkorn Memorial hospital_Ped-Endocrinology

    Bangkok, 10330, Thailand

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

    Kyiv, 04114, Ukraine

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011, Japan

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

    Salzburg, A 5020, Austria

  • LKH St. Poelten, Kinder-und Jugendheilkunde

    Sankt Pölten, 3100, Austria

  • Med. Kinder- und Poliklinik

    Bern, 3010, Switzerland

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

    Graz, 8036, Austria

  • Meir MC - Department of Paediatrics

    Kfar Saba, 44281, Israel

  • MultiCare Inst for Res & Innov

    Tacoma, Washington, 98405, United States

  • NYU Langone Hospital-LI

    Garden City, New York, 11530, United States

  • NYU Langone Hospital-LI

    Mineola, New York, 11501, United States

  • Nara Prefecture General Medical Center_ Nara-shi, Nara

    Nara-shi, Nara, 630-8581, Japan

  • Nara Prefecture General Medical Center_Pediatric

    Nara-shi, Nara, 630-8581, Japan

  • National Center for Child Health and Dev, Endo and Metabo

    Tokyo, 157 8535, Japan

  • National Center for Child Health and Development_Endo and Metabo

    Tokyo, 157 8535, Japan

  • Niigata University Medical & Dental Hospital_Pediatrics

    Niigata-shi, Niigata, 951 8520, Japan

  • Osaka City General Hospital, Pediatric Endocrinology and Me

    Osaka, 534-0021, Japan

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101, Japan

  • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia

    Milan, 20122, Italy

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Ospedale Pediatrico Gaslini

    Genova, 16147, Italy

  • Phramongkutklao Hospital_Ped-Endo_Pediatrics

    Bangkok, 10400, Thailand

  • RMAPE

    Moscow, 125373, Russia

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096, Israel

  • Republic Children's Hospital of Ministry of Health of Udmurt

    Izhevsk, 426009, Russia

  • Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064

    Copenhagen Ø, 2100, Denmark

  • Royal London Hospital_London

    London, E1 1BB, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Rutgers-Rwjms

    New Brunswick, New Jersey, 08901, United States

  • SPSBHI City Children out-patient clinic #44

    Saint Petersburg, 191144, Russia

  • SPSK nr 1 im Prof. T Sokolowskiego

    Szczecin, 71-252, Poland

  • Saitama Children's Medical Center, Endocrinorogy&Metabolism

    Saitama-shi, Saitama, 330-8777, Japan

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840, Austria

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

    Samara, 443079, Russia

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202, Israel

  • Setchenov First Moscow State Medical University

    Moscow, 119435, Russia

  • Siberian State Medical University

    Tomsk, 634050, Russia

  • St. Luke's Children's Endo

    Boise, Idaho, 83712, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Szegedi Tudományegyetem Gyermekgyógyászati Klinika

    Szeged, 6720, Hungary

  • Tallinn Children's Hospital

    Tallinn, 13419, Estonia

  • Tartu University Hospital Children's Clinic

    Tartu, 50406, Estonia

  • Univ Oklahoma Sci Ctr OK City

    Oklahoma City, Oklahoma, 73104, United States

  • Univ of AL at Birmingham_BRM

    Birmingham, Alabama, 35233, United States

  • Univ of Minnesota M.C.H.

    Minneapolis, Minnesota, 55454, United States

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

    Kyoto, 602-8566, Japan

  • University Children's Hospital Tirsova

    Belgrade, 11000, Serbia

  • University Clinical Centre Kragujevac

    Kragujevac, 34000, Serbia

  • endocrino-diabetology department, Hospital IBN BADIS.

    Constantine, 25000, Algeria

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

    Budapest, 1023, Hungary

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Other studies related to the condition(s) this trial covers.