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New growth hormone drug sogroya® tracked in kids for up to 3 years

NCT ID NCT06109935

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 200 children in Japan with growth hormone deficiency who are taking Sogroya® (somapacitan) as part of their normal care. Researchers will monitor side effects and growth over 1 to 3 years to see how safe and effective the drug is in real-world use. Participants will also fill out a questionnaire about their treatment experience.

What this could mean

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

Active substance
Somapacitan (Sogroya®), a growth hormone injection
What this could lead to
If successful, this study could confirm that Sogroya® is safe and effective for helping children with growth hormone deficiency grow taller over the long term.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. Side effects are possible, and the study only includes children in Japan, so findings may not apply elsewhere.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

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.

Who is studied

Children with short stature due to Growth Hormone Deficiency (GHD) where epiphysial discs are not closed under normal clinical practice conditions in Japan.

Ages

0 to 18 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: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Both GH treatment naïve and non-naïve children are eligible. 3. Male or female age 0 to 18 years (exclusive) at the time of signing informed consent. 4. Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment). 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. Contraindication described in approved product labelling in Japan. 1. Patients with hypersensitivity to the active substance or to any of the excipients 2. Patients with malignant tumour 3. Female patients who are either pregnant or likely to be pregnant

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    86 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Children's Health and Medical Center

    Obu-shi, Aichi, 474-8710, Japan

  • Aichi Medical University Hospital_Hepatology and pancreology

    Nagakute-shi, Aichi, 480-1195, Japan

  • Akiruno Clinic_Pediatrics

    Tokyo, 197-0802, Japan

  • Asahigawasou Ryouiku Iryou Center_Pediatrics

    Okayama, 703-8555, Japan

  • Asahikawa Medical Univ. Hospital_Pediatrics

    Asahikawa, Hokkaido, 078-8510, Japan

  • Asai Clinic_Pediatrics

    Aichi, 489-0883, Japan

  • Ayabe City Hospital_Endocrinology and Diabetes

    Kyoto, 623-0011, Japan

  • Beppu Medical Center

    Beppu-shi, Oita-ken, 874-0011, Japan

  • Chibana Clinic

    Okinawa, 904-2143, Japan

  • Clinic for Children and Youths_Pediatrics

    Saitama, 336-0967, Japan

  • Ehime University Hospital_Department of Gastro.& Metabo.

    Toon-shi, Ehime, 791-0295, Japan

  • Fujita Health University Hospital, Pediatrics

    Toyoake, Aichi, 470-1192, Japan

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-ken, 814-0133, Japan

  • Fukushima Seishi Ryougoen

    Iwaki-shi, Fukushima-ken, 970-8001, Japan

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Gifu, 501-1194, Japan

  • Haga Red Cross Hospital

    Moka-shi, Tochigi-ken, 321-4308, Japan

  • Hamamatsu Medical Center_Endocrinology and Metabolism

    Shizuoka, 432-8580, Japan

  • Hamamatsu University Hospital_Liver Internal Medicine

    Hamamatsu-shi, Shizuoka, 431-3192, Japan

  • Hanamaru Kids Clinic_Pediatrics

    Kanagawa, 227-0043, Japan

  • Hello Clinic

    Higashimatsuyama-shi, Saitama-ken, 355-0008, Japan

  • Hoshigaoka Seicho Clinic_Pediatrics

    Aichi, 464-0801, Japan

  • Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555, Japan

  • Hyogo Medical University Hospital_Pediatrics

    Nishinomiya-shi, Hyogo-ken, 663-8131, Japan

  • Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy

    Hyōgo, 654-0047, Japan

  • Ikeda Pediatrics Clinic

    Yamagata-shi, Yamagata-ken, 990-2313, Japan

  • Ina Central Hospital_Internal Medicine

    Nagano, 396-0033, Japan

  • Inomata Child Clinic_Pediatrics

    Chiba, 273-0002, Japan

  • Iwata City Hospital_Pediatrics

    Shizuoka, 438-8550, Japan

  • Iwate Medical University Hospital_Diabetes and Metabolism

    Numakunai, 028-3695, Japan

  • Iwayama Pediatric_Pediatrics

    Aichi, 468-0049, Japan

  • JCHO Osaka Hospital_Pediatric

    Osaka, 553-0003, Japan

  • JR Sendai Hospital

    Sendai-shi, Miyagi-ken, 980-0022, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyogo-ken, 670-0063, Japan

  • Kagoshima University hospital_Pediatrics

    Kagoshima, 890-8520, Japan

  • Kato Clinic

    Hachioji-shi, Tokyo-to, 192-0919, Japan

  • Kibounomori Clinic

    Osaka, 540-0003, Japan

  • Kodomohamirai Morioka Kodomo Clinic

    Morioka-shi, Iwate-ken, 020-0102, Japan

  • Kojiya Kodomo clinic

    Ota-ku, Tokyo-to, 144-0034, Japan

  • Komatsu Municipal Hospital_Pediatrics

    Ishikawa, 923-8560, Japan

  • Kumamoto University Hospital, Pediatrics

    Kumamoto-shi, Kumamoto, 860 8556, Japan

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011, Japan

  • Kyorin University Hospital_Pediatrics

    Tokyo, 181-0004, Japan

  • Kyushu University Hospital_Endocrine Metab Diab inter med

    Fukuoka-shi, Fukuoka, 812-8582, Japan

  • Mominoki Hospital, Pediatrics

    Kochi-shi, Kochi, 780 0952, Japan

  • Murakami Pediatric and Allergy clinic

    Toyama-shi, Toyama-ken, 930-0827, Japan

  • Mutsu general hospital_Pediatrics

    Aomori, 035-8601, Japan

  • Muza Kawasaki Pediatric Clinic_Pediatrics

    Kanagawa, 212-0014, Japan

  • My Clinic Ohkubo

    Shizuoka, 420-0923, Japan

  • Nagai Kids Clinic_Pediatrics

    Hyōgo, 665-0842, Japan

  • Nagasaki University Hospital_Pediatrics

    Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital, Pediatric

    Nagoya, Aichi, 467-8602, Japan

  • Naha City Hospital_Cardiovascular Medicine

    Naha-shi, Okinawa, 902-8511, Japan

  • Nakasako Kids Clinic_Pediatrics

    Hyōgo, 657-0028, Japan

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Nara Prefecture General Medical Center_Nephrology

    Nara-shi, Nara, 630-8581, 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

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa-ken, 211-0063, Japan

  • Odawara Municipal Hospital_Diabetes and Endocrinology

    Kanagawa, 250-8558, Japan

  • Oguchi Higashi Hospital_Pediatrics

    Kanagawa, 221-0014, Japan

  • Okayama University Hospital_Pediatrics

    Okayama, 700-8558, Japan

  • Okubo Kids Clinic

    Ozu-shi, Ehime-ken, 795-0061, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101, Japan

  • Ota Memorial Hospital_Pediatrics

    Gunma, 373-8585, Japan

  • Saiseikai Suita Hospital_Metabolism and Diabetes Intern

    Osaka, 564-0013, Japan

  • Sakai Smile Kids Clinic

    Sashima-gun, Ibaraki-ken, 306-0434, Japan

  • Sakura Kids Clinic_Pediatrics

    Tokyo, 154-0015, Japan

  • Seirei Sakura Citizen Hospital_Pediatrics

    Chiba, 285-8765, Japan

  • Shiga General Hospital_Diabetes and Endocrinology

    Shiga, 524-0022, Japan

  • Shiga university of Medical Science Hospital_Pediatrics

    Shiga, 520-2192, Japan

  • Shimane University Hospital_Pediatrics

    Izumo-shi, Shimane-ken, 693-0021, Japan

  • Shizuoka Children's Hospital, Department of Diabetes and metabolism

    Shizuoka-shi, Shizuoka, 420-8660, Japan

  • Shizuoka Saiseikai General Hospital_Pediatrics

    Shizuoka, 422-8527, Japan

  • Sunsun Kodomo Clinic

    Ichikawa-shi, Chiba-ken, 272-0023, Japan

  • Tanaka Growth Clinic

    Tokyo, 158-0097, Japan

  • Tendo City Hospital_Pediatrics

    Yamagata, 994-0047, Japan

  • The University of Osaka Hospital_Metabolic Medicine

    Osaka, 565-0871, Japan

  • Tokushima University Hospital_Pediatrics

    Tokushima, 770-8503, Japan

  • Toyohashi Municipal Hospital

    Toyohashi-shi, Aichi-ken, 441-8085, Japan

  • University Hospital Kyoto Prefectual University of Medicine

    Kamigyo-ku, Kyoto, 602-8566, Japan

  • University of Miyazaki Hospital_Pediatrics

    Miyazaki, 889-1692, Japan

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa-ken, 903-0125, Japan

  • Yamaguchi University Hospital_Pediatrics

    Yamaguchi, 755-8505, Japan

  • Yasuhara Children's Clinic

    Osaka, 572-0085, Japan

  • Yonekura Child Clinic_Pediatrics

    Hiroshima, 737-0046, Japan

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