Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

NCT05230550 · tracked via the Priya Life Science Japan tracker

Sponsor

Novo Nordisk A/S

Phase

Observational

Started

2022-02-03

Last updated

2026-04-13

Condition(s) studied

Adult Growth Hormone Deficiency

Investigational drug(s) / intervention(s)

Somapacitan →

Somapacitan: Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions

Study summary

Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of adverse events — From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of serious adverse events — From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of serious adverse reactions — From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of adverse reactions — From baseline (week 0) to end of study (up to 260 weeks)
Measured as number

Trial sites (47)

Facility	City	Region
Ikeda Hospital_Diabetes Medicine	Amagasaki-shi, Hyogo	Japan
University of Yamanashi Hospital	Chuo-shi, Yamanashi-ken	Japan
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus	Fukuoka	Japan
Kurume University Hospital	Fukuoka	Japan
Fukuoka University Hospital	Fukuoka-shi, Fukuoka-ken	Japan
Kyushu University Hospital_Endocrine Metab Diab inter med	Fukuoka-shi, Fukuoka	Japan
Gifu University Hospital_The Third Dept. of Internal Medicine	Gifu	Japan
Tsugaru General Hospital_Endocrinology and Diabetes	Goshogawara-shi, Aomori-ken	Japan
Gunma University Hospital_Endocrinology and Diabetes	Gunma	Japan
Hamamatsu University Hospital_Liver Internal Medicine	Hamamatsu-shi, Shizuoka	Japan
Hirosaki University Hospital	Hirosaki-shi, Aomori-ken	Japan
Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology	Hyōgo	Japan
Takara Clinic	Iida-shi, Nagano-ken	Japan
Shimane Univ. HP, Dept of Endocrinology&Metabolism	Izumo, Shimane	Japan
Joetsu General Hospital	Joetsu-shi, Niigata-ken	Japan
Kagoshima Medical Center	Kagoshima-shi, Kagoshima-ken	Japan
Kagoshima University Hospital_Neurosurgery	Kagoshima-shi, Kagoshima	Japan
Yokohama Medical Center_Diabetes and Endocrinology	Kanagawa	Japan
Kitasato University Hospital_Blood Transfusion	Kanagawa	Japan
Nara Medical University Hospital_Department of Gastro.& Metabo.	Kashihara-shi, Nara	Japan
Nippon Medical School Musashikosugi Hospital_Neurological Surgery	Kawasaki-shi, Kanagawa	Japan
Kobe University Hospital_Radiology	Kobe-shi, Hyogo	Japan
Konan Hospital	Kumamoto	Japan
Kumamoto University Hospital, Diabetes, Metabo and Endo	Kumamoto-shi, Kumamoto	Japan
Kyoto University Hospital_Department of Diabetes, Endocr	Kyoto-shi, Kyoto	Japan
Toranomon Hospital, Endocrinology and Metabolism	Minato-ku, Tokyo	Japan
University of Miyazaki Hospital	Miyazaki-shi, Miyazaki-ken	Japan
Aichi Medical University Hospital_Hepatology and pancreology	Nagakute-shi, Aichi	Japan
Okamoto Internal Medicine and Pediatrics Clinic	Nara	Japan
Kurebayashi Diabetes Clinic	Nishinomiya-shi, Hyogo-ken	Japan
Okayama University Hospital_General Medicine	Okayama-shi, Okayama	Japan
Osaka Endocrine Clinic	Osaka	Japan
Kibounomori Clinic	Osaka	Japan
Osaka City University Hospital_Metabolism and Endocrinology	Osaka	Japan
Yasuhara Children's Clinic	Osaka	Japan
Osaka Women's and Children's Hospital	Osaka	Japan
NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo	Sapporo, Hokkaido	Japan
JCHO Sendai Hospital	Sendai-shi, Miyagi-ken	Japan
Omi Medical Center_Cardiovascular Medicine	Shiga	Japan
Hamamatsu-kita-Hospital_Internal Medicine	Shizuoka	Japan

+ 7 more sites — see the full list on the official registry below.

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A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information Enrolling by invitation

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Other trials for the same condition

A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05230550 on ClinicalTrials.gov ↗ ← All trials in Japan