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

NCT05718570 · tracked via the Priya Life Science USA tracker

Sponsor

Novo Nordisk A/S

Phase

Observational

Started

2023-02-03

Last updated

2026-06-12

Condition(s) studied

Adult Growth Hormone Deficiency

Investigational drug(s) / intervention(s)

Somapacitan

Somapacitan: Sogroya therapy in participants with AGHD.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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).

Trial sites (55)

Facility	City	Region
Barrow Neurological Institute	Phoenix	Arizona
Keck Medical Center of USC - Outpatient Clinic	Los Angeles	California
UCLA Health	Los Angeles	California
Stanford Univ School of Med	Palo Alto	California
Advanced Rx Clinical Research	Westminster	California
Anschutz Outpatient Pavilion	Aurora	Colorado
Metabolic Research Institute Inc	West Palm Beach	Florida
Atlanta Diabetes Associates	Atlanta	Georgia
Northwestern Medical Group	Chicago	Illinois
Johns Hopkins University	Baltimore	Maryland
Tufts Medical Center	Boston	Massachusetts
Massachusetts General Hospital	Boston	Massachusetts
Brigham & Women's Hospital	Boston	Massachusetts
Washington University	St Louis	Missouri
UNMC	Omaha	Nebraska
Palm Research Center Inc-Vegas	Las Vegas	Nevada
Northern Nevada Endocrinology	Reno	Nevada
NYU Langone Orthopedic Center	New York	New York
Cornell University	New York	New York
University of North Carolina	Chapel Hill	North Carolina
Physicians East Endocrinology	Greenville	North Carolina
Oregon Health & Science University	Portland	Oregon
St Lukes Physician Group	Center Valley	Pennsylvania
Revival Research Institute, LLC	Dallas	Texas
UT Southwestern Medical Center-CRU	Dallas	Texas
EP Premier Medical Group PA	El Paso	Texas
Consano Clinical Research, LLC	Shavano Park	Texas
Puget Sound VA, University of Washington	Seattle	Washington
University Of Washington_Seattle	Seattle	Washington
HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie	Bron	France
CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie	Lille	France
APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité	Marseille	France
APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction	Paris	France
CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition	Reims	France
Uniklinik Aachen - Endokrinologie und Diabetologie	Aachen	Germany
Endokrinologikum Frankfurt	Frankfurt am Main	Germany
Universitätsklinikum Halle - Innere Medizin III	Halle	Germany
Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen	Mainz	Germany
LMU Klinikum Großhadern München - Med. Klinik	München	Germany
Medicover Neuroendokrinologie MVZ München	München	Germany

+ 15 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05718570 on ClinicalTrials.gov ↗ ← All trials in the USA