A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
- Conditions
- Adult Growth Hormone Deficiency
- Interventions
- Registration Number
- NCT05718570
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Adult Growth Hormone Deficiency (AGHD) Somapacitan 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.
- Primary Outcome Measures
Name Time Method Number of Adverse drug reaction (ADRs) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as count of events.
Incident Neoplasm From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as number of participants (yes/no).
Incident Diabetes Mellitus type 2 From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as number of participants (yes/no).
- Secondary Outcome Measures
Name Time Method Number of Medication Errors (incorrect dose administration rate) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as count of errors.
Number of Adverse Events (AEs) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as count of events.
Number of Serious Adverse Events (SAEs) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as count of events.
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as score ranging from -10 to +10.
Change in lean body mass From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as kg.
Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2) Approximately (closest routine clinical) 12 months after enrolment in study Measured as number of participants (yes/no).
Change in Weight From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as kilogram (kg).
Change in Body Mass Index (BMI) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as kilogram per square meter (kg\^m2).
Change in glycated hemoglobin (HbA1C) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as percentage (%).
Change in waist circumference From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as centimeter (cm).
Change in waist-hip ratio From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as ratio.
Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as milligrams per deciliter (mg/dL).
Change in truncal fat-mass From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as kg.
Patient reaching satisfactory clinical response Approximately (closest routine clinical) 12 months after enrolment in study Measured as number of participants (yes/no).
Change in bone density From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as grams per square centimeter (g/cm\^2).
Change in bone mineral content From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as grams (g).
Change in total body fat-mass From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as kg.
Change in body fat percentage From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as %.
Change in visceral adipose tissue (VAT) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as cm\^2.
Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as Units per liter (U/L).
Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) Measured as score ranging from -100 to +100. Lower score indicates a better health state.
Trial Locations
- Locations (41)
Stanford Univ School of Med
🇺🇸Palo Alto, California, United States
Kagoshima University Hospital_Neurosurgery
🇯🇵Kagoshima-shi, Kagoshima, Japan
St Lukes Physician Group
🇺🇸Center Valley, Pennsylvania, United States
Revival Research Institute, LLC
🇺🇸Dallas, Texas, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Universitätsmedizin Mainz, Endokrinologie und Stoffwechselerkrankungen
🇩🇪Mainz, Germany
Keck Medical Center of USC - Outpatient Clinic
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Advanced Rx Clinical Research
🇺🇸Westminster, California, United States
Anschutz Outpatient Pavilion
🇺🇸Aurora, Colorado, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
UNMC
🇺🇸Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Northern Nevada Endocrinology
🇺🇸Reno, Nevada, United States
NYU Langone Health
🇺🇸New York, New York, United States
Cornell University
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Physicians East Endocrinology
🇺🇸Greenville, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
UT Southwestern Medical Center-CRU
🇺🇸Dallas, Texas, United States
EP Premier Medical Group PA
🇺🇸El Paso, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Puget Sound VA, University of Washington
🇺🇸Seattle, Washington, United States
Universitätsklinikum Aachen Endokrinologie und Diabetologie
🇩🇪Aachen, Germany
Endokrinologikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Nippon Medical School Musashikosugi Hospital_Neurological Surgery
🇯🇵Kawasaki-shi, Kanagawa, Japan
Medizinische Klinik LMU
🇩🇪München, Germany
Medicover Neuroendokrinologie MVZ
🇩🇪München, Germany
Medicover MVZ Oldenburg
🇩🇪Oldenburg, Germany
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
🇯🇵Chikushino-shi, Fukuoka, Japan
Kobe University Hospital_Diabetes and Endocrinology
🇯🇵Kobe-shi, Hyogo, Japan
Okayama University Hospital_General Medicine
🇯🇵Okayama-shi, Okayama, Japan
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
🇯🇵Osaka-shi, Osaka, Japan
My clinic
🇸🇦Jeddah, Saudi Arabia
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
UKC Ljubljana, Endocrinology and Diabetes
🇸🇮Ljubljana, Slovenia