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

Adult Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05718570
• Other study ID #: NN8640-4515
• Secondary ID: U1111-1264-8642
• Status: Enrolling by invitation
• Start date: February 3, 2023
• Est. completion date: December 15, 2032

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 15, 2032
• Est. primary completion date: December 15, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases

Intervention

Drug:
• Somapacitan
Sogroya therapy in participants with AGHD.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen Endokrinologie und Diabetologie	Aachen
Germany	Endokrinologikum Frankfurt	Frankfurt am Main
Germany	Medicover Neuroendokrinologie MVZ	München
Germany	Medizinische Klinik LMU	München
Germany	Medicover MVZ Oldenburg	Oldenburg
Saudi Arabia	Dr Soliman Fakeeh Hospital	Jeddah
Saudi Arabia	My clinic	Jeddah
Saudi Arabia	Dr. Sulaiman Al Habib Medical Group- Olaya	Riyadh
Saudi Arabia	King Fahad Medical City	Riyadh
Slovenia	UKC Ljubljana, Endocrinology and Diabetes	Ljubljana
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Anschutz Outpatient Pavilion	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UNC- Chapel Hill	Chapel Hill	North Carolina
United States	Physicians East Endocrinology	Greenville	North Carolina
United States	Palm Research Center Inc-Vegas	Las Vegas	Nevada
United States	USC Pituitary Center	Los Angeles	California
United States	UNMC	Omaha	Nebraska
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Northern Nevada Endocrinology	Reno	Nevada
United States	Puget Sound VA, University of Washington	Seattle	Washington
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Advanced Rx Clinical Research	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  Saudi Arabia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse drug reaction (ADRs)	Measured as count of events.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Primary	Incident Neoplasm	Measured as number of participants (yes/no).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Primary	Incident Diabetes Mellitus type 2	Measured as number of participants (yes/no).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Number of Adverse Events (AEs)	Measured as count of events.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Number of Serious Adverse Events (SAEs)	Measured as count of events.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Number of Medication Errors (incorrect dose administration rate)	Measured as count of errors.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)	Measured as score ranging from -10 to +10.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)	Measured as number of participants (yes/no).	Approximately (closest routine clinical) 12 months after enrolment in study
Secondary	Change in Weight	Measured as kilogram (kg).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in Body Mass Index (BMI)	Measured as kilogram per square meter (kg^m2).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in waist circumference	Measured as centimeter (cm).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in waist-hip ratio	Measured as ratio.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)	Measured as milligrams per deciliter (mg/dL).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in glycated hemoglobin (HbA1C)	Measured as percentage (%).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in bone density	Measured as grams per square centimeter (g/cm^2).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in bone mineral content	Measured as grams (g).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in total body fat-mass	Measured as kg.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in truncal fat-mass	Measured as kg.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in lean body mass	Measured as kg.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in body fat percentage	Measured as %.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in visceral adipose tissue (VAT)	Measured as cm^2.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)	Measured as Units per liter (U/L).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)	Measured as score ranging from -100 to +100. Lower score indicates a better health state.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Secondary	Patient reaching satisfactory clinical response	Measured as number of participants (yes/no).	Approximately (closest routine clinical) 12 months after enrolment in study