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.
Study Type
OBSERVATIONAL
Enrollment
400
Sogroya therapy in participants with AGHD.
Barrow Neurological Institute
Phoenix, Arizona, United States
Keck Medical Center of USC - Outpatient Clinic
Los Angeles, California, United States
UCLA Health
Los Angeles, California, United States
Stanford Univ School of Med
Palo Alto, California, United States
Advanced Rx Clinical Research
Westminster, California, United States
Number of Adverse drug reaction (ADRs)
Measured as count of events.
Time frame: 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).
Time frame: 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).
Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Number of Adverse Events (AEs)
Measured as count of events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Approximately (closest routine clinical) 12 months after enrolment in study
Change in Weight
Measured as kilogram (kg).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in body fat percentage
Measured as %.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Approximately (closest routine clinical) 12 months after enrolment in study
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Anschutz Outpatient Pavilion
Aurora, Colorado, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Northwestern Medical Group
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
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