Clinical trial NCT05718570: A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Adult Growth Hormone Deficiency

Brief 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 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.

Primary outcomes:
measure: Number of Adverse drug reaction (ADRs)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Incident Neoplasm
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Incident Diabetes Mellitus type 2
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Number of Medication Errors (incorrect dose administration rate)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)
timeFrame: Approximately (closest routine clinical) 12 months after enrolment in study
measure: Change in Weight
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in Body Mass Index (BMI)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in waist-hip ratio
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in glycated hemoglobin (HbA1C)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in bone density
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in bone mineral content
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in total body fat-mass
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in truncal fat-mass
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in lean body mass
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in body fat percentage
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in visceral adipose tissue (VAT)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
timeFrame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
measure: Patient reaching satisfactory clinical response
timeFrame: Approximately (closest routine clinical) 12 months after enrolment in study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC - Outpatient Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Palo Alto
country: United States
facility: Stanford Univ School of Med
state: California
city: Westminster
country: United States
facility: Advanced Rx Clinical Research
state: California
city: Aurora
country: United States
facility: Anschutz Outpatient Pavilion
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: UNMC
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center Inc-Vegas
state: Nevada
city: Reno
country: United States
facility: Northern Nevada Endocrinology
state: Nevada
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Endocrinology
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Center Valley
country: United States
facility: St Lukes Physician Group
state: Pennsylvania
city: Dallas
country: United States
facility: Revival Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-CRU
state: Texas
city: El Paso
country: United States
facility: EP Premier Medical Group PA
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Seattle
country: United States
facility: Puget Sound VA, University of Washington
state: Washington
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen Endokrinologie und Diabetologie
city: Frankfurt am Main
country: Germany
facility: Endokrinologikum Frankfurt
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Endokrinologie und Stoffwechselerkrankungen
city: München
country: Germany
facility: Medizinische Klinik LMU
city: München
country: Germany
facility: Medicover Neuroendokrinologie MVZ
city: Oldenburg
country: Germany
facility: Medicover MVZ Oldenburg
city: Chikushino-shi, Fukuoka
country: Japan
facility: Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
city: Kagoshima-shi, Kagoshima
country: Japan
facility: Kagoshima University Hospital_Neurosurgery
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Nippon Medical School Musashikosugi Hospital_Neurological Surgery
city: Kobe-shi, Hyogo
country: Japan
facility: Kobe University Hospital_Diabetes and Endocrinology
city: Okayama-shi, Okayama
country: Japan
facility: Okayama University Hospital_General Medicine
city: Osaka-shi, Osaka
country: Japan
facility: Osaka City General Hospital_Endocrinology and Diabetes Mellitus
city: Jeddah
country: Saudi Arabia
facility: My clinic
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Ljubljana
country: Slovenia
facility: UKC Ljubljana, Endocrinology and Diabetes
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: