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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: Somapacitan


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with AGHD (only severe case)<br>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<br>* Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions<br>* Other names: Sogroya®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat mass | Measured as kilogram (kg) | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in body fat percentage | Measured as percent (%) | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in lean body mass | Measured as kg | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in cross-sectional total adipose tissue compartments (TAT) | Measured as square centimeter (cm^2) | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in subcutaneous adipose tissue compartments (SAT) | Measured as cm^2 | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in visceral adipose tissue compartments (VAT) | Measured as cm^2 | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in Total cholesterol (T-Cho) | Measured as milligrams per deciliter (mg/dL) | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in Low Density Lipoprotein-Cholesterol (LDL-Cho) | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in High Density Lipoprotein-Cholesterol (HDL-Cho) | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in triglyceride | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) | Measured as standard deviation score | From baseline (week 0) to end of study (up to 260 weeks) | 
| Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score | Measured as score range (0 = unfavorable to 6 = favorable) | From baseline (week 0) to end of study (up to 260 weeks) | 
| 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) | From baseline (week 0) to end of study (up to 260 weeks) |