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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: Somapacitan

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen Endokrinologie und Diabetologie
  • Frankfurt am Main, Germany, 60596
    • Endokrinologikum Frankfurt
  • München, Germany, 81667
    • Medicover Neuroendokrinologie MVZ
  • München, Germany, 80336
    • Medizinische Klinik LMU
  • Oldenburg, Germany, 26122
    • Medicover MVZ Oldenburg
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • My clinic
  • Jeddah, Saudi Arabia, 23323
    • Dr Soliman Fakeeh Hospital
  • Riyadh, Saudi Arabia, 59046
    • King Fahad Medical City
  • Riyadh, Saudi Arabia, 11643
    • Dr. Sulaiman Al Habib Medical Group- Olaya
• Slovenia
  • Ljubljana, Slovenia, 1000
    • UKC Ljubljana, Endocrinology and Diabetes
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Los Angeles, California, United States, 90033
      • USC Pituitary Center
    • Westminster, California, United States, 92683
      • Advanced Rx Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Outpatient Pavilion
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • UNMC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Inc-Vegas
    • Reno, Nevada, United States, 89511
      • Northern Nevada Endocrinology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC- Chapel Hill
    • Greenville, North Carolina, United States, 27834
      • Physicians East Endocrinology
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Washington
    • Seattle, Washington, United States, 98108-1597
      • Puget Sound VA, University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with Adult Growth Hormone Deficiency

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Somapacitan; Sogroya therapy in participants with AGHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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
Change in Weight	Measured as kilogram (kg).	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in body fat percentage	Measured as %.	From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
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)
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)
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)
Patient reaching satisfactory clinical response	Measured as number of participants (yes/no).	Approximately (closest routine clinical) 12 months after enrolment in study

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): December 15, 2032

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Endocrine System Diseases
• Other Study ID Numbers: NN8640-4515; U1111-1264-8642 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No