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

Enrolling by invitation

Conditions studied: Adult Growth Hormone Deficiency

In brief

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.

Key facts

Study ID

NCT05718570

Run by

Novo Nordisk A/S

People needed

400

Starts

2023-02-03

Expected to finish

2032-12-15

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• UT Southwestern Medical Center-CRU — Dallas, Texas, United States
• Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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