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Active, Not Recruiting

NCT Number: NCT05230550

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ikeda Hospital_Diabetes Medicine, Amagasaki-shi, Hyogo, Japan

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Somapacitan

Drug

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

Other names: Sogroya®

Primary outcomes

  1. Number of adverse events

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

    Measured as number

  2. Number of serious adverse events

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

    Measured as number

  3. Number of serious adverse reactions

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

    Measured as number

  4. Number of adverse reactions

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

    Measured as number

Secondary outcomes

  1. Change in body fat mass

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

    Measured as kilogram (kg)

  2. Change in body fat percentage

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

    Measured as percent (%)

  3. Change in lean body mass

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

    Measured as kg

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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

  10. Change in triglyceride

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

    Measured as mg/dL

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

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

    Measured as standard deviation score

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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