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Enrolling by Invitation

NCT Number: NCT05718570

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

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.

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Key information

Conditions

Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somapacitan

Drug

Sogroya therapy in participants with AGHD.

Primary outcomes

  1. 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)

    Measured as count of events.

  2. Incident Neoplasm

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

    Measured as number of participants (yes/no).

  3. Incident Diabetes Mellitus type 2

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

    Measured as number of participants (yes/no).

Secondary outcomes

  1. Number of Adverse Events (AEs)

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

    Measured as count of events.

  2. 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)

    Measured as count of events.

  3. 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)

    Measured as count of errors.

  4. 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)

    Measured as score ranging from -10 to +10.

  5. 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

    Measured as number of participants (yes/no).

  6. Change in Weight

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

    Measured as kilogram (kg).

  7. 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)

    Measured as kilogram per square meter (kg^m2).

  8. Change in waist circumference

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

    Measured as centimeter (cm).

  9. Change in waist-hip ratio

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

    Measured as ratio.

  10. 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)

    Measured as milligrams per deciliter (mg/dL).

  11. Change in glycated hemoglobin (HbA1C)

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

    Measured as percentage (%).

  12. Change in bone density

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

    Measured as grams per square centimeter (g/cm^2).

  13. Change in bone mineral content

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

    Measured as grams (g).

  14. Change in total body fat-mass

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

    Measured as kg.

  15. Change in truncal fat-mass

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

    Measured as kg.

  16. Change in lean body mass

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

    Measured as kg.

  17. Change in body fat percentage

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

    Measured as %.

  18. Change in visceral adipose tissue (VAT)

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

    Measured as cm^2.

  19. Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)

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

    Measured as Units per liter (U/L).

  20. Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

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

    Measured as score ranging from -100 to +100. Lower score indicates a better health state.

  21. Patient reaching satisfactory clinical response

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

    Measured as number of participants (yes/no).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Feb 8, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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