Adult Growth Hormone DeficiencyNCT05718570
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
An observational study of Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 55 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- Somapacitan
- How many people
- 400 participants
- Where
- 55 sitesin 6 countries
- Study dates
- 3 Feb 2023to 15 Dec 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Adult Growth Hormone Deficiency
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 6 countries
United States29 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
St Lukes Physician Group
Center Valley, Pennsylvania, 18034
University of North Carolina
Chapel Hill, North Carolina, 27514
Northwestern Medical Group
Chicago, Illinois, 60642
Revival Research Institute, LLC
Dallas, Texas, 75231
UT Southwestern Medical Center-CRU
Dallas, Texas, 75390
EP Premier Medical Group PA
El Paso, Texas, 79935
Physicians East Endocrinology
Greenville, North Carolina, 27834
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89148
Keck Medical Center of USC - Outpatient Clinic
Los Angeles, California, 90033
UCLA Health
Los Angeles, California, 90095
NYU Langone Orthopedic Center
New York, New York, 10017
Cornell University
New York, New York, 10021
UNMC
Omaha, Nebraska, 68198
Stanford Univ School of Med
Palo Alto, California, 94304
Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Health & Science University
Portland, Oregon, 97239
Northern Nevada Endocrinology
Reno, Nevada, 89511
Puget Sound VA, University of Washington
Seattle, Washington, 98108-1597
University Of Washington_Seattle
Seattle, Washington, 98195-6165
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Washington University
St Louis, Missouri, 63110
Metabolic Research Institute Inc
West Palm Beach, Florida, 33401
Advanced Rx Clinical Research
Westminster, California, 92683
Germany10 sites
Uniklinik Aachen - Endokrinologie und Diabetologie
Aachen, 52074
Endokrinologikum Frankfurt
Frankfurt am Main, 60596
Universitätsklinikum Halle - Innere Medizin III
Halle, 06120
Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen
Mainz, 55131
LMU Klinikum Großhadern München - Med. Klinik
München, 80336
Medicover Neuroendokrinologie MVZ München
München, 81667
Medicover Neuroendokrinologie MVZ
München, 81667
Medicover MVZ Oldenburg
Oldenburg, 26122
Medicover Oldenburg MVZ
Oldenburg, 26122
Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)
Würzburg, 97080
Japan6 sites
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
Chikushino-shi, Fukuoka, 818-8502
Kagoshima University Hospital_Neurosurgery
Kagoshima-shi, Kagoshima, 890-8520
Nippon Medical School Musashikosugi Hospital_Neurological Surgery
Kawasaki-shi, Kanagawa, 211-8533
Kobe University Hospital_Diabetes and Endocrinology
Kobe-shi, Hyogo, 650-0017
Okayama University Hospital_General Medicine
Okayama-shi, Okayama, 700-8558
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
Osaka-shi, Osaka, 534-0021
France5 sites
HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie
Bron, 69500
CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie
Lille, 59000
APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité
Marseille, 13005
APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction
Paris, 75013
CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition
Reims, 51100
Saudi Arabia4 sites
Dr Soliman Fakeeh Hospital
Jeddah, 23323
My clinic
Jeddah
Dr. Sulaiman Al Habib Medical Group- Olaya
Riyadh, 11643
King Fahad Medical City
Riyadh, 59046
About this study
Official title: A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice
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.
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- Somapacitan
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomapacitanDrug
Sogroya therapy in participants with AGHD.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Adult Growth Hormone Deficiency (AGHD) | 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. Receives: Drug: Somapacitan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse drug reaction (ADRs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Incident Neoplasm
Measured as number of participants (yes/no).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Incident Diabetes Mellitus type 2
Measured as number of participants (yes/no).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcomes (21)
Number of Adverse Events (AEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Number of Serious Adverse Events (SAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Number of Medication Errors (incorrect dose administration rate)
Measured as count of errors.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
Measured as score ranging from -10 to +10.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)
Measured as number of participants (yes/no).
Measured: Approximately (closest routine clinical) 12 months after enrolment in study
Change in Weight
Measured as kilogram (kg).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Body Mass Index (BMI)
Measured as kilogram per square meter (kg^m2).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in waist circumference
Measured as centimeter (cm).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in waist-hip ratio
Measured as ratio.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)
Measured as milligrams per deciliter (mg/dL).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in glycated hemoglobin (HbA1C)
Measured as percentage (%).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in bone density
Measured as grams per square centimeter (g/cm^2).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in bone mineral content
Measured as grams (g).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in total body fat-mass
Measured as kg.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in truncal fat-mass
Measured as kg.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in lean body mass
Measured as kg.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in body fat percentage
Measured as %.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in visceral adipose tissue (VAT)
Measured as cm^2.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)
Measured as Units per liter (U/L).
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Measured as score ranging from -100 to +100. Lower score indicates a better health state.
Measured: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Patient reaching satisfactory clinical response
Measured as number of participants (yes/no).
Measured: Approximately (closest routine clinical) 12 months after enrolment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start3 Feb 2023
- Primary completion15 Dec 2032 (estimated)
- Study completion15 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718570
- Sponsor's protocol ID
- NN8640-4515
- Other IDs
- U1111-1264-8642
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com