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Trial · Observational

Enrolling by invitationPhase not statedRegistry data

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

NCTNCT05718570 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4515Other idU1111-1264-8642
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Phase not stated
Enrollment
400 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
6 countries

United States, France, Germany, Japan, Saudi Arabia, Slovenia

Start
3 Feb 2023
Primary completion
15 Dec 2032 (estimated)
Completion
15 Dec 2032 (estimated)
First posted
8 Feb 2023
Last update posted
12 Jun 2026
Conditions
Adult Growth Hormone Deficiency

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242026202820302032
  1. Ph –

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

    NCT05718570

    3 Feb 2023 to est. 15 Dec 2032

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • SomapacitanDrug

Arms1

  • Other

    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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    Measured as number of participants (yes/no).

Secondary outcomes(20)

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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