DRUG
Somapacitan
Sogroya therapy in participants with AGHD.
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Status
Enrolling by invitation
Phase
Not applicable
Enrollment
400
Locations
55
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 8, 2023
Study start
Feb 3, 2023
Primary completion
Dec 15, 2032
Study completion
Dec 15, 2032
Results posted
Not reported
Registry updated
Jun 12, 2026
Outcomes
What the study measures.
Primary outcomes
Number of Adverse drug reaction (ADRs)
Time frame · From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
Incident Neoplasm
Time frame · 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
Time frame · 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 outcomes
Number of Adverse Events (AEs)
Time frame · 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)
Time frame · From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
Number of Medication Errors (incorrect dose administration rate)
Time frame · From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of errors.
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
Time frame · 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.
Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)
Time frame · Approximately (closest routine clinical) 12 months after enrolment in study
Measured as number of participants (yes/no).
Change in Weight
Time frame · 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)
Time frame · 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 waist circumference
Time frame · 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
Time frame · 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)
Time frame · From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as milligrams per deciliter (mg/dL).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. 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. 3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent. 4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as signed informed consent. 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 3. Participant with hypersensitivity to the active substance or to any of the excipients. 4. Participant with active malignancy or in treatment for active pre-existing malignancy. 5. 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 locations
55 registered sites.
France · Germany · Japan · Saudi Arabia · Slovenia · United States. Showing up to 24 locations stored in the fast local snapshot.
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
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
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Washington University
St 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 Orthopedic Center
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
St Lukes Physician Group
Center Valley, Pennsylvania, United States
Revival Research Institute, LLC
Dallas, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.