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

NCT ID: NCT05718570

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-03

Study Completion Date

2032-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Adult Growth Hormone Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Somapacitan

Intervention Type DRUG

Sogroya therapy in participants with AGHD.

Interventions

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Somapacitan

Sogroya therapy in participants with AGHD.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Keck Medical Center of USC - Outpatient Clinic

Los Angeles, California, United States

Site Status

UCLA Health

Los Angeles, California, United States

Site Status

Stanford Univ School of Med

Palo Alto, California, United States

Site Status

Advanced Rx Clinical Research

Westminster, California, United States

Site Status

Anschutz Outpatient Pavilion

Aurora, Colorado, United States

Site Status

Metabolic Research Institute Inc

West Palm Beach, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

UNMC

Omaha, Nebraska, United States

Site Status

Palm Research Center Inc-Vegas

Las Vegas, Nevada, United States

Site Status

Northern Nevada Endocrinology

Reno, Nevada, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Cornell University

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Physicians East Endocrinology

Greenville, North Carolina, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

St Lukes Physician Group

Center Valley, Pennsylvania, United States

Site Status

Revival Research Institute, LLC

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center-CRU

Dallas, Texas, United States

Site Status

EP Premier Medical Group PA

El Paso, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

Puget Sound VA, University of Washington

Seattle, Washington, United States

Site Status

University Of Washington_Seattle

Seattle, Washington, United States

Site Status

HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie

Bron, , France

Site Status

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

Lille, , France

Site Status

APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie

Marseille, , France

Site Status

APHP - LA PITIE SALPETRIERE - Service endrocrinologie et medecine de la reproduction

Paris, , France

Site Status

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

Reims, , France

Site Status

Uniklinik Aachen - Endokrinologie und Diabetologie

Aachen, , Germany

Site Status

Endokrinologikum Frankfurt

Frankfurt am Main, , Germany

Site Status

Universitätsklinikum Halle - Innere Medizin III

Halle, , Germany

Site Status

Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen

Mainz, , Germany

Site Status

LMU Klinikum Großhadern München - Med. Klinik

München, , Germany

Site Status

Medicover Neuroendokrinologie MVZ München

München, , Germany

Site Status

Medicover Neuroendokrinologie MVZ

München, , Germany

Site Status

Medicover MVZ Oldenburg

Oldenburg, , Germany

Site Status

Medicover Oldenburg MVZ

Oldenburg, , Germany

Site Status

Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

Würzburg, , Germany

Site Status

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Chikushino-shi, Fukuoka, , Japan

Site Status

Kagoshima University Hospital_Neurosurgery

Kagoshima-shi, Kagoshima, , Japan

Site Status

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa, , Japan

Site Status

Kobe University Hospital_Diabetes and Endocrinology

Kobe-shi, Hyogo, , Japan

Site Status

Okayama University Hospital_General Medicine

Okayama-shi, Okayama, , Japan

Site Status

Osaka City General Hospital_Endocrinology and Diabetes Mellitus

Osaka-shi, Osaka, , Japan

Site Status

Dr Soliman Fakeeh Hospital

Jeddah, , Saudi Arabia

Site Status

My clinic

Jeddah, , Saudi Arabia

Site Status

Dr. Sulaiman Al Habib Medical Group- Olaya

Riyadh, , Saudi Arabia

Site Status

King Fahad Medical City

Riyadh, , Saudi Arabia

Site Status

UKC Ljubljana, Endocrinology and Diabetes

Ljubljana, , Slovenia

Site Status

Countries

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United States France Germany Japan Saudi Arabia Slovenia

Other Identifiers

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NN8640-4515

Identifier Type: -

Identifier Source: org_study_id

U1111-1264-8642

Identifier Type: OTHER

Identifier Source: secondary_id