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Japan study tracks Sogroya's Long-Term safety in severe hormone deficiency

NCT ID NCT05230550

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 200 adults in Japan with severe growth hormone deficiency who are taking Sogroya as part of their normal care. Researchers will monitor side effects and changes in body composition over 2 to 5 years. Participants will also fill out quality-of-life questionnaires. The goal is to understand the drug's long-term safety and effectiveness in real-world use.

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

Feb 2022

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

Patients with Adult Growth Hormone Deficiency (only severe case)

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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/LAR and the treating physician before and independently from the decision to include the patient in this study. 3. Male or female, no age limitation 4. Diagnosis of AGHD (only severe case) 5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3. Patients with hypersensitivity to the active substance or to any of the excipients 4. Patients with malignant tumor 5. Female patients who are either pregnant or likely to be pregnant

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Conditions

The condition(s) this trial relates to.

pituitary dwarfism

As listed by the trial registrant

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

Adult growth hormone deficiency

Contacts and locations

Locations

  • Aichi Medical University Hospital_Hepatology and pancreology

    Nagakute-shi, Aichi, 480-1195, Japan

  • Ehime University Hospital_Department of Gastro.& Metabo.

    Toon-shi, Ehime, 791-0295, Japan

  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

    Fukuoka, 818 8502, Japan

  • Fukuoka University Hospital

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

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Gifu, 501-1194, Japan

  • Gunma University Hospital_Endocrinology and Diabetes

    Gunma, 371-8511, Japan

  • Hamamatsu Medical Center_Endocrinology and Metabolism

    Shizuoka, 432-8580, Japan

  • Hamamatsu University Hospital_Liver Internal Medicine

    Hamamatsu-shi, Shizuoka, 431-3192, Japan

  • Hamamatsu-kita-Hospital_Internal Medicine

    Shizuoka, 431-3113, Japan

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori-ken, 036-8203, Japan

  • Hosaka Kodomo Clinic

    Tokyo, 112-0001, Japan

  • Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology

    Hyōgo, 675-8555, Japan

  • Ikeda Hospital_Diabetes Medicine

    Amagasaki-shi, Hyogo, 661-0002, Japan

  • JCHO Sendai Hospital

    Sendai-shi, Miyagi-ken, 981-3205, Japan

  • Joetsu General Hospital

    Joetsu-shi, Niigata-ken, 943-0172, Japan

  • Kagoshima Medical Center

    Kagoshima-shi, Kagoshima-ken, 892-0853, Japan

  • Kagoshima University Hospital_Neurosurgery

    Kagoshima-shi, Kagoshima, 890-8520, Japan

  • Kibounomori Clinic

    Osaka, 540-0003, Japan

  • Kitasato University Hospital_Blood Transfusion

    Kanagawa, 252-0375, Japan

  • Kobe University Hospital_Radiology

    Kobe-shi, Hyogo, 650-0017, Japan

  • Konan Hospital

    Kumamoto, 862-0970, Japan

  • Kumamoto University Hospital, Diabetes, Metabo and Endo

    Kumamoto-shi, Kumamoto, 860-0811, Japan

  • Kurebayashi Diabetes Clinic

    Nishinomiya-shi, Hyogo-ken, 663-8024, Japan

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Kyoto University Hospital_Department of Diabetes, Endocr

    Kyoto-shi, Kyoto, 606-8507, Japan

  • Kyushu University Hospital_Endocrine Metab Diab inter med

    Fukuoka-shi, Fukuoka, 812-8582, Japan

  • NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo

    Sapporo, Hokkaido, 060-8648, Japan

  • Nara Medical University Hospital_Department of Gastro.& Metabo.

    Kashihara-shi, Nara, 634-8522, Japan

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa, 211-8533, Japan

  • Okamoto Internal Medicine and Pediatrics Clinic

    Nara, 633-0064, Japan

  • Okayama University Hospital_General Medicine

    Okayama-shi, Okayama, 700-8558, Japan

  • Omi Medical Center_Cardiovascular Medicine

    Shiga, 525-8585, Japan

  • Osaka City University Hospital_Metabolism and Endocrinology

    Osaka, 545-8586, Japan

  • Osaka Endocrine Clinic

    Osaka, 530-0013, Japan

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101, Japan

  • Shimane Univ. HP, Dept of Endocrinology&Metabolism

    Izumo, Shimane, 691-8501, Japan

  • Shizuoka General Hospital

    Shizuoka-shi, Shizuoka-ken, 420-0881, Japan

  • Takara Clinic

    Iida-shi, Nagano-ken, 395-0804, Japan

  • Tochigi Medical Center Shimotsuga_Neurosurgery

    Tochigi-shi, Tochigi-ken, 329-4407, Japan

  • Toranomon Hospital, Endocrinology and Metabolism

    Minato-ku, Tokyo, 105-8470, Japan

  • Tottori University Hospital_Endocrinology and Metabolism

    Tottori, 683-8504, Japan

  • Tsugaru General Hospital_Endocrinology and Diabetes

    Goshogawara-shi, Aomori-ken, 037-0074, Japan

  • University of Miyazaki Hospital

    Miyazaki-shi, Miyazaki-ken, 889-1601, Japan

  • University of Yamanashi Hospital

    Chuo-shi, Yamanashi-ken, 409-3821, Japan

  • Yamagata University Hospital, Internal Medicine 3

    Yamagata-shi, Yamagata, 990-9585, Japan

  • Yasuhara Children's Clinic

    Osaka, 572-0085, Japan

  • Yokohama Medical Center_Diabetes and Endocrinology

    Kanagawa, 245-8575, Japan

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