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Weekly shot could replace daily needles for kids with growth hormone deficiency

NCT ID NCT02616562

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new once-weekly growth hormone injection (somapacitan) against the standard daily growth hormone shot in 76 children with growth hormone deficiency who had never been treated before. The main goal was to see how well the weekly shot worked for height growth and how safe it was over 26 weeks, with an extra 26-week follow-up. If successful, this could mean fewer injections for children, but larger studies are still needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
somapacitan (once-weekly growth hormone injection)
What this could lead to
If it works, this could allow children with growth hormone deficiency to receive just one injection per week instead of daily shots, making treatment easier.
What could go wrong
This is a phase 2 trial with only 76 children, so larger studies are needed. The weekly shot may not work as well as daily injections for all children, and injection site reactions are possible.

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

76 people

The number who actually took part.

Started

Mar 2016

Finished

Sep 2024

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 10 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: * Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening * 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: * Any clinically significant abnormality likely to affect growth or the ability to evaluate * 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

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Conditions

The condition(s) this trial relates to.

isolated congenital growth hormone deficiency

As listed by the trial registrant

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

Growth hormone deficiency in children Growth hormone disorder

Contacts and locations

Locations

  • Study site

    Graz, 8036, Austria

  • Study site

    Brussels, 1090, Belgium

  • Study site

    São Paulo, São Paulo, 01228-000, Brazil

  • Study site

    Bordeaux, 33076, France

  • Study site

    Frankfurt, 60596, Germany

  • Study site

    New Dehli, New Delhi, 110029, India

  • Study site

    Kfar Saba, 44281, Israel

  • Study site

    Tokyo, 157 8535, Japan

  • Study site

    Ljubljana, 1525, Slovenia

  • Study site

    Stockholm, 171 76, Sweden

  • Study site

    Istanbul, 34093, Turkey (Türkiye)

  • Study site

    Kiev, 04114, Ukraine

  • 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

  • Astrid Lindgrens Barnsjukhus

    Stockholm, 171 76, Sweden

  • Barn och ungdomscentrum Västerbotten

    Umeå, 901 85, Sweden

  • CCHMC_Cinc

    Cincinnati, Ohio, 45229, United States

  • CHU de Liège, site N.-D. des Bruyères

    Liège, 4030, Belgium

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • Centre Hospitalier Universitaire D'Angers-2

    Angers, 49033, France

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire de Nantes-Hopital Enfant-Adolescent

    Nantes, 44000, France

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hsptl Of The Kings

    Norfolk, Virginia, 23507, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Childrens Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Brussels, 1200, Belgium

  • Dell Pediatric Research Institute

    Austin, Texas, 78723, United States

  • Endocrine Associates Of Dallas

    Plano, Texas, 75093, United States

  • Endokrinologikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07962, United States

  • HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie

    Toulouse, 31059, France

  • HOPITAL SUD de RENNES

    Rennes, 35056, France

  • Hacettepe Üniversitesi Hastanesi- Endokrinoloji

    Ankara, 06230, Turkey (Türkiye)

  • Hospital São Lucas - PUC/RS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • I.U Istanbul Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Institute of Science Tokyo Hospital_Pediatrics

    Tokyo, 113-8519, Japan

  • Ivano-Frankivsk Regional Clinical Children Hospital - Endocrinology dept.

    Ivano-Frankivsk, 76018, Ukraine

  • JCHO Osaka Hospital_Pediatric

    Osaka, 553-0003, Japan

  • Jehangir Clinical Development Centre

    Pune, Maharashtra, 411001, India

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

    Linz, Upper Austria, 4020, Austria

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

    Kyiv, 04114, Ukraine

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011, Japan

  • Kyushu Univ. HP, Maternity & Perinatal Care Center

    Fukuoka, 812-8582, Japan

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

    Salzburg, 5020, Austria

  • LKH St. Poelten, Kinder-und Jugendheilkunde

    Sankt Pölten, 3100, Austria

  • Landeskrankenhaus Villach

    Villach, 9500, Austria

  • Marmara University Medical Faculty

    Istanbul, 34854, Turkey (Türkiye)

  • Marmara Üniversitesi Pendik EAH- Başıbüyük Yerleşkesi- Kardiyoloji

    Istanbul, 34854, Turkey (Türkiye)

  • Mattel Children's Hospital at UCLA

    Los Angeles, California, 90095, United States

  • 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

    Mineola, New York, 11501, United States

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

    Tokyo, 157 8535, Japan

  • Nemours/AI duPont Hosp-Chld

    Wilmington, Delaware, 19803, United States

  • Novo Nordisk Clinical Trial Call Center

    San Diego, California, 92123, United States

  • Novo Nordisk Clinical Trial Call Center

    Minneapolis, Minnesota, 55454, United States

  • Novo Nordisk Clinical Trial Call Center

    Morristown, New Jersey, 07962, United States

  • Novo Nordisk Clinical Trial Call Center

    Mineola, New York, 11501, United States

  • Novo Nordisk Clinical Trial Call Center

    Cincinnati, Ohio, 45229, United States

  • Osaka City General Hospital, Pediatric Endocrinology and Me

    Osaka, 534-0021, Japan

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101, Japan

  • Ped Endo Assoc PC-G.V

    Greenwood Village, Colorado, 80111-2803, United States

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096, Israel

  • Riley Hospital For Children

    Indianapolis, Indiana, 46202, United States

  • Rocky Mt Ped and Endo

    Centennial, Colorado, 80112, United States

  • Rutgers-Rwjms

    New Brunswick, New Jersey, 08901, United States

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840, Austria

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202, Israel

  • Serviço de Endocrinologia e Metabologia do HC-UFPR

    Curitiba, Paraná, 80030-110, Brazil

  • Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

    Tel Litwinsky, 52621, Israel

  • Soroka MC - Pediatric Endocrinology

    Beersheba, 84101, Israel

  • St. Marianna University School of Medicine Hospital_Pediatrics

    Kanagawa, 216-8511, Japan

  • The Endocrine Center

    Pembroke Pines, Florida, 33028, United States

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • The Regents of the Univ of CA

    San Diego, California, 92123, United States

  • Tokyo Medical and Dental University Hospital

    Tokyo, 113-8519, Japan

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203, United States

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)

    Ulm, 89075, Germany

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

    Kyoto, 602-8566, Japan

  • University Children's Hospital

    Ljubljana, 1525, Slovenia

  • University Of Oklahoma-Tulsa

    Tulsa, Oklahoma, 74135, United States

  • University of Minnesota_Minneapolis_2

    Minneapolis, Minnesota, 55454, United States

  • Valley Children's Hospital

    Madera, California, 93636-8762, United States

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

    Adana, 01130, Turkey (Türkiye)

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