A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Study Overview
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Brief Summary
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In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Official Title
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A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

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 (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice. Exclusion Criteria: Previous participation in this study. Participation is defined as signed informed consent. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. Participant with hypersensitivity to the active substance or to any of the excipients. Participant with active malignancy or in treatment for active pre-existing malignancy. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 Adult Growth Hormone Deficiency (AGHD)<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 participant with Sogroya has been made prior to and independently from the decision to include the participant in this study. | Drug: Somapacitan<br>* Sogroya therapy in participants with AGHD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse drug reaction (ADRs) | Measured as count of events. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Incident Neoplasm | Measured as number of participants (yes/no). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Incident Diabetes Mellitus type 2 | Measured as number of participants (yes/no). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Measured as count of events. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Number of Serious Adverse Events (SAEs) | Measured as count of events. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Number of Medication Errors (incorrect dose administration rate) | Measured as count of errors. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) | Measured as score ranging from -10 to +10. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2) | Measured as number of participants (yes/no). | Approximately (closest routine clinical) 12 months after enrolment in study | 
| Change in Weight | Measured as kilogram (kg). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in Body Mass Index (BMI) | Measured as kilogram per square meter (kg^m2). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in waist circumference | Measured as centimeter (cm). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in waist-hip ratio | Measured as ratio. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides) | Measured as milligrams per deciliter (mg/dL). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in glycated hemoglobin (HbA1C) | Measured as percentage (%). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in bone density | Measured as grams per square centimeter (g/cm^2). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in bone mineral content | Measured as grams (g). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in total body fat-mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in truncal fat-mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in lean body mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in body fat percentage | Measured as %. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in visceral adipose tissue (VAT) | Measured as cm^2. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin) | Measured as Units per liter (U/L). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) | Measured as score ranging from -100 to +100. Lower score indicates a better health state. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | 
| Patient reaching satisfactory clinical response | Measured as number of participants (yes/no). | Approximately (closest routine clinical) 12 months after enrolment in study |