A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

PHASE3CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

July 22, 2021

Primary Completion Date

November 17, 2023

Study Completion Date

December 18, 2023

Conditions
Growth Hormone Deficiency in Children
Interventions
DRUG

somapacitan

Somapacitan (0.16 mg/kg/week) will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

DRUG

Norditropin®

Norditropin® (0.034 mg/kg/day) will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

Trial Locations (25)

100045

Beijing Children's Hospital, Capital Medical University, Beijing

130021

The First Bethune Hospital of Jilin University-Pediatric, Changchun

214023

Wuxi Children's Hospital-Pediatric Endocrinology, Wuxi

Wuxi Children's Hospital, Wuxi

215025

Children's Hospital of Soochow University-Endocrine Genetics and Metabolism, Suzhou

Children's Hospital of Soochow University, Suzhou

230601

The Second Hospital of Anhui Medical University, Hefei

250098

Shandong Provincial Hospital-Pediatric, Jinan

266034

Qingdao Women and Children's Hospital-Pediatric Endocrinology&Metabolism, Qingdao

266043

Qingdao Women and Children's Hospital, Qingdao

310052

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

314001

The First Hospital of Jiaxing-Pediatric, Jiaxing

The First Hospital of Jiaxing, Jiaxing

330006

Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism, Nanchang

337055

Pingxiang Maternal and Child Health Care Hospital-Child Health Care, Pingxiang

Pingxiang Maternal and Child Health Care Hospital, Pingxiang

410007

Hunan Children's Hospital-Child Health Center, Changsha

Hunan Children's Hospital, Changsha

410011

The Second Xiangya Hospital of Central South University, Changsha

422001

The First Affiliated Hospital of Shaoyang University-Pediatric, Shaoyang

430030

Tongji Hospital, Tongji Medical College of HUST-Pediatric, Wuhan

450018

Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism, Zhengzhou

Henan Children's Hospital, Zhengzhou

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

610000

Chengdu Women's and Children's Central Hospital, Chengdu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT04970654 - A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. | Biotech Hunter | Biotech Hunter