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IGF-1

Insulin-like Growth Factor 1, Somatomedin C

Quick Stats
Studies 92
Trials 100
Completed PHASE2, PHASE3 INTERVENTIONAL NCT04513171

Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a multicenter, randomized, open-labeled, positive controlled phase 2\&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.

Detailed Description

This multicenter, randomized, open-labeled, positive controlled study is divided into two stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin, while the second one is aimed to confirm the efficacy and safety of the study drug. A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled. Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.

Interventions

Name: Y-shape pegylated somatropin
Type: DRUG
Description: Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.
Name: Y-shape pegylated somatropin
Type: DRUG
Description: Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.
Name: Y-shape pegylated somatropin
Type: DRUG
Description: Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
Name: Norditropin®
Type: DRUG
Description: Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
Name: Y-shape pegylated somatropin
Type: DRUG
Description: Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
Name: Norditropin
Type: DRUG
Description: Norditropin 245μg/kg/week, subcutaneous injection, Once daily.

Primary Outcomes

Measure: Phase 2: Change of areas under the curve of IGF-1 concentration from baseline (ΔIGF-1 AUC).
TimeFrame: 12 weeks
Description:
Measure: Phase 3: Height velocity.
TimeFrame: 52 weeks
Description:

Trial Information

NCT ID

NCT04513171

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Last Updated

December 15, 2025