NCT05230550

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Somapacitan	Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions

Timeline

• Start date: 2022-02-03
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-02-09
• Last updated: 2026-04-13

Locations

47 sites across 1 country: Japan