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

Last updated: May 19, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Growth Hormone Deficiencies/abnormalities

Treatment

Somapacitan

Clinical Study ID

NCT05718570
NN8640-4515
U1111-1264-8642
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  2. The decision to initiate treatment with commercially available Sogroya (somapacitan)has been made by the participant and the treating physician before and independentlyfrom 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

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as signed informedconsent.

  2. Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

  3. Participant with hypersensitivity to the active substance or to any of theexcipients.

  4. Participant with active malignancy or in treatment for active pre-existingmalignancy.

  5. Participant with acute critical illness, suffering from complications following openheart surgery, abdominal surgery, multiple accidental trauma, acute respiratoryfailure or similar conditions per investigator judgement.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Somapacitan
Phase:
Study Start date:
February 03, 2023
Estimated Completion Date:
December 15, 2032

Connect with a study center

  • Novo Nordisk Investigational Site

    Aachen, 52074
    Germany

    Site Not Available

  • Universitätsklinikum Aachen Endokrinologie und Diabetologie

    Aachen, 52074
    Germany

    Site Not Available

  • Endokrinologikum Frankfurt

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Universitätsmedizin Mainz, Endokrinologie und Stoffwechselerkrankungen

    Mainz, 55131
    Germany

    Site Not Available

  • Medicover Neuroendokrinologie MVZ

    München, 81667
    Germany

    Site Not Available

  • Medizinische Klinik LMU

    München, 80336
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    München, 81667
    Germany

    Site Not Available

  • Medicover MVZ Oldenburg

    Oldenburg, 26122
    Germany

    Site Not Available

  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

    Chikushino-shi, Fukuoka, 818-8502
    Japan

    Site Not Available

  • Kagoshima University Hospital_Neurosurgery

    Kagoshima-shi, Kagoshima, 890-8520
    Japan

    Site Not Available

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa, 211-8533
    Japan

    Site Not Available

  • Kobe University Hospital_Diabetes and Endocrinology

    Kobe-shi, Hyogo, 650-0017
    Japan

    Site Not Available

  • Okayama University Hospital_General Medicine

    Okayama-shi, Okayama, 700-8558
    Japan

    Site Not Available

  • Osaka City General Hospital_Endocrinology and Diabetes Mellitus

    Osaka-shi, Osaka, 534-0021
    Japan

    Site Not Available

  • Dr Soliman Fakeeh Hospital

    Jeddah, 23323
    Saudi Arabia

    Site Not Available

  • My clinic

    Jeddah,
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Jeddah,
    Saudi Arabia

    Site Not Available

  • Dr. Sulaiman Al Habib Medical Group- Olaya

    Riyadh, 11643
    Saudi Arabia

    Site Not Available

  • King Fahad Medical City

    Riyadh, 59046
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Riyadh, 59046
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • UKC Ljubljana, Endocrinology and Diabetes

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Keck Medical Center of USC - Outpatient Clinic

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCLA Health

    Los Angeles, California 90095
    United States

    Site Not Available

  • USC Pituitary Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Stanford Univ School of Med

    Palo Alto, California 94304
    United States

    Site Not Available

  • Advanced Rx Clinical Research

    Westminster, California 92683
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westminster, California 92683
    United States

    Site Not Available

  • Anschutz Outpatient Pavilion

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • UNMC

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Northern Nevada Endocrinology

    Reno, Nevada 89511
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Reno, Nevada 89511
    United States

    Site Not Available

  • CTSI Research Center

    New York, New York 10016
    United States

    Site Not Available

  • Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10017
    United States

    Site Not Available

  • UNC- Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Physicians East Endocrinology

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • St Lukes Physician Group

    Center Valley, Pennsylvania 18034
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center-CRU

    Dallas, Texas 75390
    United States

    Site Not Available

  • EP Premier Medical Group PA

    El Paso, Texas 79935
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Javara Inc. / Texas Health Care, PLLC

    Weatherford, Texas 76087
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Seattle, Washington 98108-1597
    United States

    Site Not Available

  • Puget Sound VA, University of Washington

    Seattle, Washington 98108-1597
    United States

    Site Not Available

  • University Of Washington_Seattle

    Seattle, Washington 98195-6165
    United States

    Site Not Available

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