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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05718570




Registration number
NCT05718570
Ethics application status
Date submitted
30/01/2023
Date registered
8/02/2023

Titles & IDs
Public title
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Scientific 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
Secondary ID [1] 0 0
U1111-1264-8642
Secondary ID [2] 0 0
NN8640-4515
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Growth Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Somapacitan

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.


Treatment: Drugs: Somapacitan
Sogroya therapy in participants with AGHD.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse drug reaction (ADRs)
Timepoint [1] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Primary outcome [2] 0 0
Incident Neoplasm
Timepoint [2] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Primary outcome [3] 0 0
Incident Diabetes Mellitus type 2
Timepoint [3] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [1] 0 0
Number of Adverse Events (AEs)
Timepoint [1] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [2] 0 0
Number of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [3] 0 0
Number of Medication Errors (incorrect dose administration rate)
Timepoint [3] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [4] 0 0
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
Timepoint [4] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [5] 0 0
Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)
Timepoint [5] 0 0
Approximately (closest routine clinical) 12 months after enrolment in study
Secondary outcome [6] 0 0
Change in Weight
Timepoint [6] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [7] 0 0
Change in Body Mass Index (BMI)
Timepoint [7] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [8] 0 0
Change in waist circumference
Timepoint [8] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [9] 0 0
Change in waist-hip ratio
Timepoint [9] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [10] 0 0
Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)
Timepoint [10] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [11] 0 0
Change in glycated hemoglobin (HbA1C)
Timepoint [11] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [12] 0 0
Change in bone density
Timepoint [12] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [13] 0 0
Change in bone mineral content
Timepoint [13] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [14] 0 0
Change in total body fat-mass
Timepoint [14] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [15] 0 0
Change in truncal fat-mass
Timepoint [15] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [16] 0 0
Change in lean body mass
Timepoint [16] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [17] 0 0
Change in body fat percentage
Timepoint [17] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [18] 0 0
Change in visceral adipose tissue (VAT)
Timepoint [18] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [19] 0 0
Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)
Timepoint [19] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [20] 0 0
Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Timepoint [20] 0 0
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary outcome [21] 0 0
Patient reaching satisfactory clinical response
Timepoint [21] 0 0
Approximately (closest routine clinical) 12 months after enrolment in study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2032
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Germany
State/province [14] 0 0
Aachen
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt am Main
Country [16] 0 0
Germany
State/province [16] 0 0
München
Country [17] 0 0
Germany
State/province [17] 0 0
Oldenburg
Country [18] 0 0
Saudi Arabia
State/province [18] 0 0
Jeddah
Country [19] 0 0
Saudi Arabia
State/province [19] 0 0
Riyadh
Country [20] 0 0
Slovenia
State/province [20] 0 0
Ljubljana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05718570