A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for … (NCT05718570) | Clinical Trial Compass
By InvitationNot Applicable
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
United States, France, Germany400 participantsStarted 2023-02-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse drug reaction (ADRs)
Timeframe: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
2
Incident Neoplasm
Timeframe: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
3
Incident Diabetes Mellitus type 2
Timeframe: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
. 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.