DRUG
Somapacitan
Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Status
Active, not recruiting
Phase
Not applicable
Enrollment
200
Locations
47
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 9, 2022
Study start
Feb 3, 2022
Primary completion
Dec 31, 2026
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Apr 13, 2026
Outcomes
What the study measures.
Primary outcomes
Number of adverse events
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of serious adverse events
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of serious adverse reactions
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of adverse reactions
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Secondary outcomes
Change in body fat mass
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as kilogram (kg)
Change in body fat percentage
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as percent (%)
Change in lean body mass
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as kg
Change in cross-sectional total adipose tissue compartments (TAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as square centimeter (cm\^2)
Change in subcutaneous adipose tissue compartments (SAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as cm\^2
Change in visceral adipose tissue compartments (VAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as cm\^2
Change in Total cholesterol (T-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as milligrams per deciliter (mg/dL)
Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as mg/dL
Change in High Density Lipoprotein-Cholesterol (HDL-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as mg/dL
Change in triglyceride
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Measured as mg/dL
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- Not reported
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
Study locations
47 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.