CClinicalTrials.gg
Active, not recruitingNCT05230550Updated Apr 13, 2026

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

An observational study in Adult Growth Hormone Deficiency, sponsored by Novo Nordisk A/S. Active, not recruiting at 47 sites in Japan. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Sex
All
01

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.

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Conditions studied

  • Adult Growth Hormone Deficiency

Browse trials for

03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 37 observational studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with Adult Growth Hormone Deficiency (only severe case)

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugSomapacitan

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

    Also known as: Sogroya®

06

What researchers measure

Primary outcomes

  1. Number of adverse events

    Measured as number

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

  2. Number of serious adverse events

    Measured as number

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

  3. Number of serious adverse reactions

    Measured as number

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

  4. Number of adverse reactions

    Measured as number

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

Secondary outcomes

  1. Change in body fat mass

    Measured as kilogram (kg)

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

  2. Change in body fat percentage

    Measured as percent (%)

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

  3. Change in lean body mass

    Measured as kg

    Time frame: 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)

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

  5. Change in subcutaneous adipose tissue compartments (SAT)

    Measured as cm\^2

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

  6. Change in visceral adipose tissue compartments (VAT)

    Measured as cm\^2

    Time frame: 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)

    Time frame: 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

    Time frame: 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

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

  10. Change in triglyceride

    Measured as mg/dL

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

47 sites
  • Ikeda Hospital_Diabetes Medicine
    Amagasaki-shi, Hyogo, 661-0002, Japan
  • University of Yamanashi Hospital
    Chuo-shi, Yamanashi-ken, 409-3821, Japan
  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
    Fukuoka, 818 8502, Japan
  • Kurume University Hospital
    Fukuoka, 830-0011, Japan
  • Fukuoka University Hospital
    Fukuoka-shi, Fukuoka-ken, 814-0133, Japan
  • Kyushu University Hospital_Endocrine Metab Diab inter med
    Fukuoka-shi, Fukuoka, 812-8582, Japan
  • Gifu University Hospital_The Third Dept. of Internal Medicine
    Gifu, 501-1194, Japan
  • Tsugaru General Hospital_Endocrinology and Diabetes
    Goshogawara-shi, Aomori-ken, 037-0074, Japan
  • Gunma University Hospital_Endocrinology and Diabetes
    Gunma, 371-8511, Japan
  • Hamamatsu University Hospital_Liver Internal Medicine
    Hamamatsu-shi, Shizuoka, 431-3192, Japan
  • Hirosaki University Hospital
    Hirosaki-shi, Aomori-ken, 036-8203, Japan
  • Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology
    Hyōgo, 675-8555, Japan
  • Takara Clinic
    Iida-shi, Nagano-ken, 395-0804, Japan
  • Shimane Univ. HP, Dept of Endocrinology&Metabolism
    Izumo, Shimane, 691-8501, 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
  • Yokohama Medical Center_Diabetes and Endocrinology
    Kanagawa, 245-8575, Japan
  • Kitasato University Hospital_Blood Transfusion
    Kanagawa, 252-0375, 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
  • 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
  • Kyoto University Hospital_Department of Diabetes, Endocr
    Kyoto-shi, Kyoto, 606-8507, Japan
  • Toranomon Hospital, Endocrinology and Metabolism
    Minato-ku, Tokyo, 105-8470, Japan
  • University of Miyazaki Hospital
    Miyazaki-shi, Miyazaki-ken, 889-1601, Japan
  • Aichi Medical University Hospital_Hepatology and pancreology
    Nagakute-shi, Aichi, 480-1195, Japan
  • Okamoto Internal Medicine and Pediatrics Clinic
    Nara, 633-0064, Japan
  • Kurebayashi Diabetes Clinic
    Nishinomiya-shi, Hyogo-ken, 663-8024, Japan
  • Okayama University Hospital_General Medicine
    Okayama-shi, Okayama, 700-8558, Japan
  • Osaka Endocrine Clinic
    Osaka, 530-0013, Japan
  • Kibounomori Clinic
    Osaka, 540-0003, Japan
  • Osaka City University Hospital_Metabolism and Endocrinology
    Osaka, 545-8586, Japan
  • Yasuhara Children's Clinic
    Osaka, 572-0085, Japan
  • Osaka Women's and Children's Hospital
    Osaka, 594-1101, Japan
  • NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo
    Sapporo, Hokkaido, 060-8648, Japan
  • JCHO Sendai Hospital
    Sendai-shi, Miyagi-ken, 981-3205, Japan
  • Omi Medical Center_Cardiovascular Medicine
    Shiga, 525-8585, Japan
  • Hamamatsu-kita-Hospital_Internal Medicine
    Shizuoka, 431-3113, Japan
  • Hamamatsu Medical Center_Endocrinology and Metabolism
    Shizuoka, 432-8580, Japan
  • Shizuoka General Hospital
    Shizuoka-shi, Shizuoka-ken, 420-0881, Japan
  • Tochigi Medical Center Shimotsuga_Neurosurgery
    Tochigi-shi, Tochigi-ken, 329-4407, Japan
  • Hosaka Kodomo Clinic
    Tokyo, 112-0001, Japan
  • Ehime University Hospital_Department of Gastro.& Metabo.
    Toon-shi, Ehime, 791-0295, Japan
  • Tottori University Hospital_Endocrinology and Metabolism
    Tottori, 683-8504, Japan
  • Yamagata University Hospital, Internal Medicine 3
    Yamagata-shi, Yamagata, 990-9585, Japan
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05230550
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 9, 2022
Start date
Feb 3, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 13, 2026

Study contacts

Clinical Transparency dept. 2834
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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