Evidence map›Paper›PMID 39607675›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

A Novel Y-Shaped Pegylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency.

Yan Liang, Haiyan Wei, Fan Yang, Hua Zhang, Linqi Chen, Hui Yao, Xiaoming Luo, Xinran Cheng, Yu Yang, Qun Lian and 19 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Yan LiangDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.ORCID 0000-0002-9009-3284
Haiyan WeiDepartment of Endocrinology, Genetics and Metabolism, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou 450018, China.
Fan YangDepartment of Pediatrics, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu 610066, China.
Hua ZhangDepartment of Pediatrics, Sanya Central Hospital, Sanya 572000, China.
Linqi ChenDepartment of Endocrinology, Metabolism and Genetic Disorders, Children's Hospital of Soochow University, Suzhou 215003, China.
Hui YaoDepartment of Genetic Metabolism and Endocrinology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430015, China.
Xiaoming LuoDepartment of Pediatrics, Zhejiang Provincial People's Hospital, Hangzhou 310014, China.
Xinran ChengDepartment of Pediatric Endocrinology, Genetics, and Metabolism, The Affiliated Women's and Children's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu Women's and Children's Central Hospital, Chengdu 610031, China.
Yu YangDepartment of Endocrinology, Genetics and Metabolism, Jiangxi Provincial Children's Hospital, Nanchang 330006, China.
Qun LianDepartment of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China.
Hongwei DuDepartment of Pediatrics, The First Affiliated Hospital, Jilin University, Changchun 130031, China.
Tang LiDepartment of Pediatric Endocrinology and Metabolism, Women and Children's Hospital, Qingdao University, Qingdao 266035, China.
Pin LiDepartment of Endocrinology, Children's Hospital of Shanghai, Shanghai Jiao Tong University, Shanghai 200040, China.
Gaixiu ZhangDepartment of Pediatric Endocrinology, Shanxi Provincial Children's Hospital, Taiyuan 030006, China.
Fuying SongDepartment of Endocrinology, Children's Hospital, Capital Institute of Pediatrics, Beijing 100020, China.
Liyang LiangDepartment of Pediatric Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510120, China.
Deyun LiuDepartment of Pediatrics, The Second Hospital of Anhui Medical University, Hefei 230601, China.
Shunye ZhuDepartment of Pediatrics, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou 510630, China.
Haihong GongDepartment of Pediatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
Chunxiu GongDepartment of Endocrinology, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.
Xiangao ChengDepartment of Pediatrics, The First Affiliated Hospital of Anhui Medical University, Hefei 230031, China.
Zhuangjian XuDepartment of Pediatrics, Wuxi Fourth People's Hospital, Wuxi 214101, China.
Yaping MaDepartment of Pediatrics, Wuxi Fourth People's Hospital, Wuxi 214101, China.
Zhe SuDepartment of Endocrinology, Shenzhen Children's Hospital, Shenzhen 518038, China.ORCID 0000-0003-4101-8429
Weidong ZhouOffice of General Manager, Xiamen Amoytop Biotech Co Ltd, Xiamen 361028, China.
Ruoyi HeOffice of General Manager, Xiamen Amoytop Biotech Co Ltd, Xiamen 361028, China.
Yalin YinDepartment of Translational Medicine, Xiamen Amoytop Biotech Co Ltd, Xiamen 361028, China.
Li SunOffice of General Manager, Xiamen Amoytop Biotech Co Ltd, Xiamen 361028, China.
Xiaoping LuoDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.ORCID 0000-0002-3748-4817

Funding

Fourteenth Five-Year PlanNational Key Research and Development Projects 2023YFC2706300Xiamen Amoytop Biotech Co, Ltd
6 · The paper itself

Abstract

contextPegpesen is a novel Y-shape pegylated recombinant human growth hormone (rhGH) for once-weekly treatment of children with growth hormone deficiency (GHD).

objectiveThis work aimed to evaluate the efficacy and safety of Pegpesen in children with GHD vs daily rhGH.

methodsA multicenter, randomized, controlled phase 3 clinical trial was conducted at 23 centers in China with a duration of 52 weeks' treatment. There were 391 pediatric participants diagnosed with GHD. Participants were randomly assigned 2:1 to a weekly Pegpesen group (140 μg/kg/week) or a daily rhGH group (245 μg/kg/week) for 52 weeks. The primary end point was the growth velocity (GV) at 52 weeks, and the secondary end points mainly involved changes from baseline in height SD scores for chronological age and bone age (ΔHt SDS CA and ΔHt SDS BA).

resultsAt 52 weeks, the least squares mean (LS means) of GV was 9.910 cm/year in the Pegpesen group and 10.037 cm/year in the daily rhGH group. The LS means difference between groups was -0.127 (95% CI, -0.4868 to 0.2332), confirming that weekly Pegpesen is noninferior to daily rhGH. The LS means of ΔHt SDS CA, ΔHt SDS BA, were similar across both groups (all P > .05). Safety profiles and adherence were comparable.

conclusionPegpesen was noninferior to daily rhGH, with similar safety, lower dosage requirements, thus presenting a new therapeutic option for children with GHD.

Indexed as

Dwarfism, PituitaryGrowth DisordersHuman Growth HormonePolyethylene GlycolsAdolescentBody HeightChildChild, PreschoolChinaFemaleHumansMaleRecombinant ProteinsTreatment OutcomeHuman Growth HormonePolyethylene GlycolsRecombinant Proteinsgrowth hormonegrowth hormone deficiencylong-acting growth hormonepediatricY-shape pegylated rhGH

Identifiers

PMID39607675
PMCPMC12261095

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.