NCT03075644

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.

Conditions

• Growth Hormone Disorder
• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	somapacitan	Once weekly subcutaneous injections (s.c., under the skin)
DRUG	Norditropin	Daily subcutaneous injections (s.c., under the skin)

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-10-04
• Completion: 2018-10-04
• First posted: 2017-03-09
• Last updated: 2020-11-23
• Results posted: 2020-10-06

Locations

12 sites across 1 country: Japan