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Enrolling by invitation NCT05718570

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

— Observational Adult Growth Hormone Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Somapacitan.
Who it may be relevant to
Registry conditions: Adult Growth Hormone Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, Japan, Saudi Arabia +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Somapacitan
    Sogroya therapy in participants with AGHD.

Primary outcome measures

  • Number of Adverse drug reaction (ADRs) [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Incident Neoplasm [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Incident Diabetes Mellitus type 2 [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
Secondary outcome measures (12)
  • Number of Adverse Events (AEs) [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Number of Serious Adverse Events (SAEs) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Approximately (closest routine clinical) 12 months after enrolment in study]
  • Change in Weight [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Change in Body Mass Index (BMI) [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Change in waist circumference [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Change in waist-hip ratio [Time frame: 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) [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Change in glycated hemoglobin (HbA1C) [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
  • Change in bone density [Time frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 29 centers
  • Barrow Neurological Institute — Phoenix
  • Keck Medical Center of USC - Outpatient Clinic — Los Angeles
  • UCLA Health — Los Angeles
  • Stanford Univ School of Med — Palo Alto
  • Advanced Rx Clinical Research — Westminster
  • Anschutz Outpatient Pavilion — Aurora
  • Metabolic Research Institute Inc — West Palm Beach
  • Atlanta Diabetes Associates — Atlanta
  • … and 21 more centers
Germany · 10 centers
  • Uniklinik Aachen - Endokrinologie und Diabetologie — Aachen
  • Endokrinologikum Frankfurt — Frankfurt am Main
  • Universitätsklinikum Halle - Innere Medizin III — Halle
  • Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen — Mainz
  • LMU Klinikum Großhadern München - Med. Klinik — München
  • Medicover Neuroendokrinologie MVZ München — München
  • Medicover Neuroendokrinologie MVZ — München
  • Medicover MVZ Oldenburg — Oldenburg
  • … and 2 more centers
Japan · 6 centers
  • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus — Chikushino-shi, Fukuoka
  • Kagoshima University Hospital_Neurosurgery — Kagoshima-shi, Kagoshima
  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery — Kawasaki-shi, Kanagawa
  • Kobe University Hospital_Diabetes and Endocrinology — Kobe-shi, Hyogo
  • Okayama University Hospital_General Medicine — Okayama-shi, Okayama
  • Osaka City General Hospital_Endocrinology and Diabetes Mellitus — Osaka-shi, Osaka
France · 5 centers
  • HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie — Bron
  • CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie — Lille
  • APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité — Marseille
  • APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction — Paris
  • CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition — Reims
Saudi Arabia · 4 centers
  • Dr Soliman Fakeeh Hospital — Jeddah
  • My clinic — Jeddah
  • Dr. Sulaiman Al Habib Medical Group- Olaya — Riyadh
  • King Fahad Medical City — Riyadh
Slovenia · 1 center
  • UKC Ljubljana, Endocrinology and Diabetes — Ljubljana

Identifiers

NCT: NCT05718570 · NN8640-4515 · U1111-1264-8642

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗