Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan

Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 818 8502
    • Novo Nordisk Investigational Site
  • Kumamoto, Japan, 862-0970
    • Novo Nordisk Investigational Site
  • Kumamoto-shi, Kumamoto, Japan, 860-0811
    • Novo Nordisk Investigational Site
  • Kyoto-shi, Kyoto, Japan, 606-8507
    • Novo Nordisk Investigational Site
  • Nara, Japan, 633-0064
    • Novo Nordisk Investigational Site
  • Oosakashi, Japan, 540-0003
    • Novo Nordisk Investigational Site
  • Osaka, Japan, 572-0085
    • Novo Nordisk Investigational Site
  • Osaka, Japan, 530-0013
    • Novo Nordisk Investigational Site
  • Tokyo, Japan, 112-0001
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with Adult Growth Hormone Deficiency (only severe case)

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® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.
3. Male or female, no age limitation
4. Diagnosis of AGHD (only severe case)
5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with hypersensitivity to the active substance or to any of the excipients
4. Patients with malignant tumor
5. Female patients who are either pregnant or likely to be pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with AGHD (only severe case); 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 patient with Sogroya® has been made at the treating physician's discretion and independently from the decision to include the patient in this study.	Drug: Somapacitan; Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions; Other Names: Sogroya®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Number of serious adverse events	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Number of serious adverse reactions	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Number of adverse reactions	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body fat mass	Measured as kilogram (kg)	From baseline (week 0) to end of study (up to 260 weeks)
Change in body fat percentage	Measured as percent (%)	From baseline (week 0) to end of study (up to 260 weeks)
Change in lean body mass	Measured as kg	From baseline (week 0) to end of study (up to 260 weeks)
Change in cross-sectional total adipose tissue compartments (TAT)	Measured as square centimeter (cm^2)	From baseline (week 0) to end of study (up to 260 weeks)
Change in subcutaneous adipose tissue compartments (SAT)	Measured as cm^2	From baseline (week 0) to end of study (up to 260 weeks)
Change in visceral adipose tissue compartments (VAT)	Measured as cm^2	From baseline (week 0) to end of study (up to 260 weeks)
Change in Total cholesterol (T-Cho)	Measured as milligrams per deciliter (mg/dL)	From baseline (week 0) to end of study (up to 260 weeks)
Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Change in High Density Lipoprotein-Cholesterol (HDL-Cho)	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Change in triglyceride	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)	Measured as standard deviation score	From baseline (week 0) to end of study (up to 260 weeks)
Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score	Measured as score range (0 = unfavorable to 6 = favorable)	From baseline (week 0) to end of study (up to 260 weeks)
Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score	Measured as score range (1 to 5; lower score indicates a better health state)	From baseline (week 0) to end of study (up to 260 weeks)

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, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary
• Other Study ID Numbers: NN8640-4638; U1111-1247-5417 (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