Evidence map›Paper›PMID 40324364›Full record

Trial reportHormone research in paediatrics2026

Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.

Junfen Fu, Xinran Cheng, Michael Højby, Chunxiu Gong, Tina Lund Leunbach, Yanhong Li, Haiyan Wei, Yu Zhu, Yining Zhang, Yan Zhong

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hormone research in paediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04970654 (A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 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.

NCT04970654 phase3completednot on this map

A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2023Enrolled110ConditionsGrowth Hormone Deficiency in ChildrenArmssomapacitan, Norditropin®
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
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

10 authors.

Junfen FuEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China, fjf68@zju.edu.cn.
Xinran ChengDepartment of Pediatric Genetics, Endocrinology and Metabolism, Chengdu Women and Children's Center Hospital, Chengdu, China.
Michael HøjbyClinical Development, Novo Nordisk A/S, Søborg, Denmark.
Chunxiu GongDepartment of Endocrinology, Genetics and Metabolism, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing, China.
Tina Lund LeunbachClinical Development, Novo Nordisk A/S, Søborg, Denmark.
Yanhong LiDepartment of PediatrIcs, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Haiyan WeiChildren's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou, China.
Yu ZhuNovo Nordisk Shanghai, Shanghai, China.
Yining ZhangDepartment of Endocrinology, Genetics and Metabolism, Children's Medical Center, The First Hospital of Jilin University, Changchun, China.
Yan ZhongHunan Children's Hospital, Changsha, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionREAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).

methods110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks. Annualized height velocity (HV; cm/year) at week 52 was the primary measurement. Additional assessments included HV standard deviation score (SDS), height SDS (HSDS), bone age, insulin-like growth factor-I (IGF-I) SDS, and observer-reported outcomes.

resultsEstimated mean HV at week 52 was 11.0 and 10.4 cm/year for somapacitan and daily GH, respectively. Non-inferiority of somapacitan compared to daily GH was confirmed. Changes in HVSDS, HSDS, bone age, and IGF-I SDS from baseline to week 52 were similar between groups. At week 52, mean (SD) IGF-I SDS was within intended reference range (-2.0 to +2.0) and comparable between groups: +0.5 (1.4) for somapacitan versus +0.1 (1.2) for daily GH. Somapacitan was well tolerated with a safety profile consistent with the well-known safety profile of daily GH. A low proportion of injection site reactions were reported for somapacitan (2.7%), with no reports of injection site pain during the 52-week treatment period. Disease burden was reduced from baseline to week 52 for both treatments. Somapacitan reduced treatment burden compared to daily GH.

conclusionsEfficacy and safety profiles were comparable for Chinese children with GHD treated with somapacitan or daily GH. Both treatments similarly reduced disease burden, while treatment burden was reduced with somapacitan.

Indexed as

Dwarfism, PituitaryHuman Growth HormoneAdolescentBody HeightChildChild, PreschoolChinaEast Asian PeopleFemaleHumansInsulin-Like Growth Factor IMaleHuman Growth HormoneInsulin-Like Growth Factor IGrowth hormone deficiencyGrowth hormone replacement therapyHeightLong-acting growth hormoneSomapacitan

Identifiers

PMID40324364
PMCPMC12129415

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Registered trials

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.