NCT06007417

A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency

The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.

Detailed description

The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.

Conditions

• GHD

Interventions

Type	Name	Description
DRUG	GenSci004	GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
DRUG	Genotropin	Genotropin

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2023-08-23
• Last updated: 2023-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study