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Adult Growth Hormone DeficiencyNCT05230550

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

An observational study of Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 47 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Adult Growth Hormone Deficiency
What is being tested?
Somapacitan
How many people
200 participants
Where
47 sitesJapan
Study dates
3 Feb 2022to 31 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Patients with Adult Growth Hormone Deficiency (only severe case)

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

Japan47 sites

  • Ikeda Hospital_Diabetes Medicine

    Amagasaki-shi, Hyogo, 661-0002

  • University of Yamanashi Hospital

    Chuo-shi, Yamanashi-ken, 409-3821

  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

    Fukuoka, 818 8502

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Kyushu University Hospital_Endocrine Metab Diab inter med

    Fukuoka-shi, Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-ken, 814-0133

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Gifu, 501-1194

  • Tsugaru General Hospital_Endocrinology and Diabetes

    Goshogawara-shi, Aomori-ken, 037-0074

  • Gunma University Hospital_Endocrinology and Diabetes

    Gunma, 371-8511

  • Hamamatsu University Hospital_Liver Internal Medicine

    Hamamatsu-shi, Shizuoka, 431-3192

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori-ken, 036-8203

  • Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology

    Hyōgo, 675-8555

  • Takara Clinic

    Iida-shi, Nagano-ken, 395-0804

  • Shimane Univ. HP, Dept of Endocrinology&Metabolism

    Izumo, Shimane, 691-8501

  • Joetsu General Hospital

    Joetsu-shi, Niigata-ken, 943-0172

  • Kagoshima University Hospital_Neurosurgery

    Kagoshima-shi, Kagoshima, 890-8520

  • Kagoshima Medical Center

    Kagoshima-shi, Kagoshima-ken, 892-0853

  • Yokohama Medical Center_Diabetes and Endocrinology

    Kanagawa, 245-8575

  • Kitasato University Hospital_Blood Transfusion

    Kanagawa, 252-0375

  • Nara Medical University Hospital_Department of Gastro.& Metabo.

    Kashihara-shi, Nara, 634-8522

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa, 211-8533

  • Kobe University Hospital_Radiology

    Kobe-shi, Hyogo, 650-0017

  • Konan Hospital

    Kumamoto, 862-0970

  • Kumamoto University Hospital, Diabetes, Metabo and Endo

    Kumamoto-shi, Kumamoto, 860-0811

  • Kyoto University Hospital_Department of Diabetes, Endocr

    Kyoto-shi, Kyoto, 606-8507

  • Toranomon Hospital, Endocrinology and Metabolism

    Minato-ku, Tokyo, 105-8470

  • University of Miyazaki Hospital

    Miyazaki-shi, Miyazaki-ken, 889-1601

  • Aichi Medical University Hospital_Hepatology and pancreology

    Nagakute-shi, Aichi, 480-1195

  • Okamoto Internal Medicine and Pediatrics Clinic

    Nara, 633-0064

  • Kurebayashi Diabetes Clinic

    Nishinomiya-shi, Hyogo-ken, 663-8024

  • Okayama University Hospital_General Medicine

    Okayama-shi, Okayama, 700-8558

  • Osaka Endocrine Clinic

    Osaka, 530-0013

  • Kibounomori Clinic

    Osaka, 540-0003

  • Osaka City University Hospital_Metabolism and Endocrinology

    Osaka, 545-8586

  • Yasuhara Children's Clinic

    Osaka, 572-0085

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101

  • NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo

    Sapporo, Hokkaido, 060-8648

  • JCHO Sendai Hospital

    Sendai-shi, Miyagi-ken, 981-3205

  • Omi Medical Center_Cardiovascular Medicine

    Shiga, 525-8585

  • Hamamatsu-kita-Hospital_Internal Medicine

    Shizuoka, 431-3113

  • Hamamatsu Medical Center_Endocrinology and Metabolism

    Shizuoka, 432-8580

  • Shizuoka General Hospital

    Shizuoka-shi, Shizuoka-ken, 420-0881

  • Tochigi Medical Center Shimotsuga_Neurosurgery

    Tochigi-shi, Tochigi-ken, 329-4407

  • Hosaka Kodomo Clinic

    Tokyo, 112-0001

  • Ehime University Hospital_Department of Gastro.& Metabo.

    Toon-shi, Ehime, 791-0295

  • Tottori University Hospital_Endocrinology and Metabolism

    Tottori, 683-8504

  • Yamagata University Hospital, Internal Medicine 3

    Yamagata-shi, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan

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.

Being tested
Somapacitan
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SomapacitanDrug

    Also called Sogroya®

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

Study groups in NCT05230550
Study groupRoleWhat they receive
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.
Receives: Drug: Somapacitan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    Measured as number

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

  2. Number of serious adverse events

    Measured as number

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

  3. Number of serious adverse reactions

    Measured as number

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

  4. Number of adverse reactions

    Measured as number

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

Secondary outcomes (13)

  1. Change in body fat mass

    Measured as kilogram (kg)

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

  2. Change in body fat percentage

    Measured as percent (%)

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

  3. Change in lean body mass

    Measured as kg

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

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

    Measured as square centimeter (cm^2)

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

  5. Change in subcutaneous adipose tissue compartments (SAT)

    Measured as cm^2

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

  6. Change in visceral adipose tissue compartments (VAT)

    Measured as cm^2

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

  7. Change in Total cholesterol (T-Cho)

    Measured as milligrams per deciliter (mg/dL)

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

  8. Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)

    Measured as mg/dL

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

  9. Change in High Density Lipoprotein-Cholesterol (HDL-Cho)

    Measured as mg/dL

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

  10. Change in triglyceride

    Measured as mg/dL

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

  11. Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)

    Measured as standard deviation score

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

  12. Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score

    Measured as score range (0 = unfavorable to 6 = favorable)

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

  13. Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score

    Measured as score range (1 to 5; lower score indicates a better health state)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start3 Feb 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230550
Sponsor's protocol ID
NN8640-4638
Other IDs
U1111-1247-5417
Status last verified
Apr 2026
First submitted
28 Jan 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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