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

NCT05230550 | Active Not Recruiting

• 2 other identifiers: NN8640-4638U1111-1247-5417
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (4)

• Number of adverse events

  Measured as number

  From baseline (week 0) to end of study (up to 260 weeks)

• Number of serious adverse events

  Measured as number

  From baseline (week 0) to end of study (up to 260 weeks)

• Number of serious adverse reactions

  Measured as number

  From baseline (week 0) to end of study (up to 260 weeks)

• Number of adverse reactions

  Measured as number

  From baseline (week 0) to end of study (up to 260 weeks)

Secondary Outcomes (13)

• Change in body fat mass

  From baseline (week 0) to end of study (up to 260 weeks)

• Change in body fat percentage

  From baseline (week 0) to end of study (up to 260 weeks)

• Change in lean body mass

  From baseline (week 0) to end of study (up to 260 weeks)

• Change in cross-sectional total adipose tissue compartments (TAT)

  From baseline (week 0) to end of study (up to 260 weeks)

• Change in subcutaneous adipose tissue compartments (SAT)

  From baseline (week 0) to end of study (up to 260 weeks)

Study Arms (1)

Participants with AGHD (only severe case)

Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. The decision to treat a patient with Sogroya® has been made at the treating physician's discretion and independently from the decision to include the patient in this study.

Drug: Somapacitan

Interventions

Somapacitan DRUG

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

Also known as: Sogroya®

Participants with AGHD (only severe case)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Adult Growth Hormone Deficiency (only severe case)

You may qualify if:

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
• 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.
• Male or female, no age limitation
• Diagnosis of AGHD (only severe case)
• 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.

You may not qualify if:

• Previous participation in this study. Participation is defined as having given informed consent in this study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Patients with hypersensitivity to the active substance or to any of the excipients
• Patients with malignant tumor
• Female patients who are either pregnant or likely to be pregnant

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (47)

Ikeda Hospital_Diabetes Medicine

Amagasaki-shi, Hyogo, 661-0002, Japan

Location

University of Yamanashi Hospital

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

Location

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Fukuoka, 818 8502, Japan

Location

Kurume University Hospital

Fukuoka, 830-0011, Japan

Location

Fukuoka University Hospital

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

Location

Kyushu University Hospital_Endocrine Metab Diab inter med

Fukuoka-shi, Fukuoka, 812-8582, Japan

Location

Gifu University Hospital_The Third Dept. of Internal Medicine

Gifu, 501-1194, Japan

Location

Tsugaru General Hospital_Endocrinology and Diabetes

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

Location

Gunma University Hospital_Endocrinology and Diabetes

Gunma, 371-8511, Japan

Location

Hamamatsu University Hospital_Liver Internal Medicine

Hamamatsu-shi, Shizuoka, 431-3192, Japan

Location

Hirosaki University Hospital

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

Location

Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology

Hyōgo, 675-8555, Japan

Location

Takara Clinic

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

Location

Shimane Univ. HP, Dept of Endocrinology&Metabolism

Izumo, Shimane, 691-8501, Japan

Location

Joetsu General Hospital

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

Location

Kagoshima Medical Center

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

Location

Kagoshima University Hospital_Neurosurgery

Kagoshima-shi, Kagoshima, 890-8520, Japan

Location

Yokohama Medical Center_Diabetes and Endocrinology

Kanagawa, 245-8575, Japan

Location

Kitasato University Hospital_Blood Transfusion

Kanagawa, 252-0375, Japan

Location

Nara Medical University Hospital_Department of Gastro.& Metabo.

Kashihara-shi, Nara, 634-8522, Japan

Location

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa, 211-8533, Japan

Location

Kobe University Hospital_Radiology

Kobe-shi, Hyogo, 650-0017, Japan

Location

Konan Hospital

Kumamoto, 862-0970, Japan

Location

Kumamoto University Hospital, Diabetes, Metabo and Endo

Kumamoto-shi, Kumamoto, 860-0811, Japan

Location

Kyoto University Hospital_Department of Diabetes, Endocr

Kyoto-shi, Kyoto, 606-8507, Japan

Location

Toranomon Hospital, Endocrinology and Metabolism

Minato-ku, Tokyo, 105-8470, Japan

Location

University of Miyazaki Hospital

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

Location

Aichi Medical University Hospital_Hepatology and pancreology

Nagakute-shi, Aichi, 480-1195, Japan

Location

Okamoto Internal Medicine and Pediatrics Clinic

Nara, 633-0064, Japan

Location

Kurebayashi Diabetes Clinic

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

Location

Okayama University Hospital_General Medicine

Okayama-shi, Okayama, 700-8558, Japan

Location

Osaka Endocrine Clinic

Osaka, 530-0013, Japan

Location

Kibounomori Clinic

Osaka, 540-0003, Japan

Location

Osaka City University Hospital_Metabolism and Endocrinology

Osaka, 545-8586, Japan

Location

Yasuhara Children's Clinic

Osaka, 572-0085, Japan

Location

Osaka Women's and Children's Hospital

Osaka, 594-1101, Japan

Location

NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo

Sapporo, Hokkaido, 060-8648, Japan

Location

JCHO Sendai Hospital

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

Location

Omi Medical Center_Cardiovascular Medicine

Shiga, 525-8585, Japan

Location

Hamamatsu-kita-Hospital_Internal Medicine

Shizuoka, 431-3113, Japan

Location

Hamamatsu Medical Center_Endocrinology and Metabolism

Shizuoka, 432-8580, Japan

Location

Shizuoka General Hospital

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

Location

Tochigi Medical Center Shimotsuga_Neurosurgery

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

Location

Hosaka Kodomo Clinic

Tokyo, 112-0001, Japan

Location

Ehime University Hospital_Department of Gastro.& Metabo.

Toon-shi, Ehime, 791-0295, Japan

Location

Tottori University Hospital_Endocrinology and Metabolism

Tottori, 683-8504, Japan

Location

Yamagata University Hospital, Internal Medicine 3

Yamagata-shi, Yamagata, 990-9585, Japan

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitan

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: February 3, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (47)