New study tracks Sogroya's safety over a decade in growth hormone deficiency

NCT ID NCT05718570

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 400 adults with growth hormone deficiency who are already taking Sogroya (somapacitan) as part of their normal care. Researchers will monitor side effects and effectiveness over 5 to 10 years. Participants will also fill out questionnaires about their well-being and daily activities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Somapacitan (Sogroya)
What this could lead to
If successful, this study could confirm that Sogroya is safe and effective for long-term use in adults with growth hormone deficiency.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only monitors routine care, so it won't prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with Adult Growth Hormone Deficiency

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    55 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Marseille, 13005, France

  • APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction

    Paris, 75013, France

  • Advanced Rx Clinical Research

    Westminster, California, 92683, United States

  • Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

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

    Lille, 59000, France

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

    Reims, 51100, France

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Cornell University

    New York, New York, 10021, United States

  • Dr Soliman Fakeeh Hospital

    Jeddah, 23323, Saudi Arabia

  • Dr. Sulaiman Al Habib Medical Group- Olaya

    Riyadh, 11643, Saudi Arabia

  • EP Premier Medical Group PA

    El Paso, Texas, 79935, United States

  • Endokrinologikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

    Chikushino-shi, Fukuoka, 818-8502, Japan

  • HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie

    Bron, 69500, France

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kagoshima University Hospital_Neurosurgery

    Kagoshima-shi, Kagoshima, 890-8520, Japan

  • Keck Medical Center of USC - Outpatient Clinic

    Los Angeles, California, 90033, United States

  • King Fahad Medical City

    Riyadh, 59046, Saudi Arabia

  • Kobe University Hospital_Diabetes and Endocrinology

    Kobe-shi, Hyogo, 650-0017, Japan

  • LMU Klinikum Großhadern München - Med. Klinik

    München, 80336, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medicover MVZ Oldenburg

    Oldenburg, 26122, Germany

  • Medicover Neuroendokrinologie MVZ

    München, 81667, Germany

  • Medicover Neuroendokrinologie MVZ München

    München, 81667, Germany

  • Medicover Oldenburg MVZ

    Oldenburg, 26122, Germany

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401, United States

  • My clinic

    Jeddah, Saudi Arabia

  • NYU Langone Orthopedic Center

    New York, New York, 10017, United States

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa, 211-8533, Japan

  • Northern Nevada Endocrinology

    Reno, Nevada, 89511, United States

  • Northwestern Medical Group

    Chicago, Illinois, 60642, United States

  • Okayama University Hospital_General Medicine

    Okayama-shi, Okayama, 700-8558, Japan

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka City General Hospital_Endocrinology and Diabetes Mellitus

    Osaka-shi, Osaka, 534-0021, Japan

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148, United States

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834, United States

  • Puget Sound VA, University of Washington

    Seattle, Washington, 98108-1597, United States

  • Revival Research Institute, LLC

    Dallas, Texas, 75231, United States

  • St Lukes Physician Group

    Center Valley, Pennsylvania, 18034, United States

  • Stanford Univ School of Med

    Palo Alto, California, 94304, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCLA Health

    Los Angeles, California, 90095, United States

  • UKC Ljubljana, Endocrinology and Diabetes

    Ljubljana, 1000, Slovenia

  • UNMC

    Omaha, Nebraska, 68198, United States

  • UT Southwestern Medical Center-CRU

    Dallas, Texas, 75390, United States

  • Uniklinik Aachen - Endokrinologie und Diabetologie

    Aachen, 52074, Germany

  • University Of Washington_Seattle

    Seattle, Washington, 98195-6165, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • Universitätsklinikum Halle - Innere Medizin III

    Halle, 06120, Germany

  • Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

    Würzburg, 97080, Germany

  • Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen

    Mainz, 55131, Germany

  • Washington University

    St Louis, Missouri, 63110, United States

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