NCT06709040

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.

Conditions

• Growth Hormone Deficiency
• Neoplasms
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	Somapacitan	Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.

Timeline

• Start date: 2024-12-13
• Primary completion: 2034-04-14
• Completion: 2034-04-14
• First posted: 2024-11-29
• Last updated: 2026-04-06

Locations

1 site across 1 country: United Kingdom