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

NCT05718570 | Enrolling By Invitation

• 2 other identifiers: NN8640-4515U1111-1264-8642
• Study Type: observational
• Target: 400
• Locations: 6 countries
• Sites: 55

Brief 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.

Conditions

Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (3)

• Number of Adverse drug reaction (ADRs)

  Measured as count of events.

  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).

  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).

  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)

  From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)

• Number of Serious Adverse Events (SAEs)

  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)

  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)

  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)

  Approximately (closest routine clinical) 12 months after enrolment in study

Study Arms (1)

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.

Drug: Somapacitan

Interventions

Somapacitan DRUG

Sogroya therapy in participants with AGHD.

Participants with Adult Growth Hormone Deficiency (AGHD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Adult Growth Hormone Deficiency

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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (55)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Keck Medical Center of USC - Outpatient Clinic

Los Angeles, California, 90033, United States

Location

UCLA Health

Los Angeles, California, 90095, United States

Location

Stanford Univ School of Med

Palo Alto, California, 94304, United States

Location

Advanced Rx Clinical Research

Westminster, California, 92683, United States

Location

Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60642, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

UNMC

Omaha, Nebraska, 68198, United States

Location

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89148, United States

Location

Northern Nevada Endocrinology

Reno, Nevada, 89511, United States

Location

NYU Langone Orthopedic Center

New York, New York, 10017, United States

Location

Cornell University

New York, New York, 10021, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Physicians East Endocrinology

Greenville, North Carolina, 27834, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

St Lukes Physician Group

Center Valley, Pennsylvania, 18034, United States

Location

Revival Research Institute, LLC

Dallas, Texas, 75231, United States

Location

UT Southwestern Medical Center-CRU

Dallas, Texas, 75390, United States

Location

EP Premier Medical Group PA

El Paso, Texas, 79935, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Puget Sound VA, University of Washington

Seattle, Washington, 98108-1597, United States

Location

University Of Washington_Seattle

Seattle, Washington, 98195-6165, United States

Location

HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie

Bron, 69500, France

Location

CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie

Lille, 59000, France

Location

APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité

Marseille, 13005, France

Location

APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction

Paris, 75013, France

Location

CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition

Reims, 51100, France

Location

Uniklinik Aachen - Endokrinologie und Diabetologie

Aachen, 52074, Germany

Location

Endokrinologikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Universitätsklinikum Halle - Innere Medizin III

Halle, 06120, Germany

Location

Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen

Mainz, 55131, Germany

Location

LMU Klinikum Großhadern München - Med. Klinik

München, 80336, Germany

Location

Medicover Neuroendokrinologie MVZ München

München, 81667, Germany

Location

Medicover Neuroendokrinologie MVZ

München, 81667, Germany

Location

Medicover MVZ Oldenburg

Oldenburg, 26122, Germany

Location

Medicover Oldenburg MVZ

Oldenburg, 26122, Germany

Location

Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

Würzburg, 97080, Germany

Location

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Kagoshima University Hospital_Neurosurgery

Kagoshima-shi, Kagoshima, 890-8520, Japan

Location

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa, 211-8533, Japan

Location

Kobe University Hospital_Diabetes and Endocrinology

Kobe-shi, Hyogo, 650-0017, Japan

Location

Okayama University Hospital_General Medicine

Okayama-shi, Okayama, 700-8558, Japan

Location

Osaka City General Hospital_Endocrinology and Diabetes Mellitus

Osaka-shi, Osaka, 534-0021, Japan

Location

Dr Soliman Fakeeh Hospital

Jeddah, 23323, Saudi Arabia

Location

My clinic

Jeddah, Saudi Arabia

Location

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, 11643, Saudi Arabia

Location

King Fahad Medical City

Riyadh, 59046, Saudi Arabia

Location

UKC Ljubljana, Endocrinology and Diabetes

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitan

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): December 15, 2032
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SA (4); DE (10); FR (5); SL (1); JP (6); US (29)