Evidence map›Paper›PMID 42369274›Full record

ArticleJournal of the Endocrine Society2026

Model-based somapacitan dosing and IGF-I response in children born SGA or with ISS, Noonan or Turner syndromes.

Julie Desrochers, Philippe Backeljauw, Michael Højby, Rasmus Juul Kildemoes, Agnès Linglart, Jun Mori, Rory Forseth Leisegang

2 registry-linked trialsAbstract read
In one paragraph

Article in Journal of the Endocrine Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05330325 phase3active not recruitingnot on this map

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

TypeinterventionalSponsorNovo Nordisk A/SRan2022 to 2027Enrolled412ConditionsSGA, Turner Syndrome, Noonan Syndrome, ISSArmsSomapacitan, Norditropin®
NCT05723835 phase3active not recruitingnot on this map

A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

TypeinterventionalSponsorNovo Nordisk A/SRan2023 to 2027Enrolled47ConditionsSGA, Turner Syndrome, Noonan Syndrome, ISSArmsSomapacitan
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

7 authors.

Julie DesrochersMedical & Translational Sciences, Novo Nordisk A/S, Søborg 2860, Denmark.ORCID https://orcid.org/0000-0002-5068-2172
Philippe BackeljauwDivision of Diabetes and Endocrinology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA.ORCID https://orcid.org/0000-0003-2398-9520
Michael HøjbyMedical & Translational Sciences, Novo Nordisk A/S, Søborg 2860, Denmark.ORCID https://orcid.org/0000-0002-2210-0366
Rasmus Juul KildemoesMedical & Translational Sciences, Novo Nordisk A/S, Søborg 2860, Denmark.ORCID https://orcid.org/0000-0002-0965-9333
Agnès LinglartUniversité Paris-Saclay, AP-HP, INSERM, Service d'Endocrinologie et diabète de l'enfant, Hôpital Bicêtre Paris Saclay, F-94270 Le Kremlin-Bicêtre, France.ORCID https://orcid.org/0000-0003-3455-002X
Jun MoriDivision of Pediatric Endocrinology, Metabolism and Nephrology, Children's Medical Center, Osaka City General Hospital, Osaka 534-0021, Japan.ORCID https://orcid.org/0000-0002-1271-1577
Rory Forseth LeisegangMedical & Translational Sciences, Novo Nordisk A/S, Søborg 2860, Denmark.ORCID https://orcid.org/0000-0003-0810-4771

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Context: The weekly insulin-like growth factor I (IGF-I) profile for children and adolescents treated with long-acting growth hormone differs from that of daily growth hormone (GH). Objective: The objective of this study is to provide guidance on the use of once-weekly somapacitan and IGF-I monitoring in prepubertal short children and adolescents born small for gestational age (SGA) or with idiopathic short stature (ISS), Noonan syndrome (NS), or Turner syndrome (TS). Methods: Modeling, including population pharmacokinetic/pharmacodynamic (PK/PD) modeling, were utilized, analyzing IGF-I data from 4 clinical studies, including 2 phase 3 trials (REAL8: NCT05330325; REAL9: NCT05723835) involving children and adolescents born SGA ( Results: Relationships between somapacitan dose, exposure, baseline IGF-I SD score (SDS), and height velocity (HV) were established in children born SGA, with similar responses anticipated for those with ISS, NS, or TS. A linear model enabled the estimation of average weekly IGF-I exposure from a single sample collected during the somapacitan dosing interval. IGF-I SDS simulations support flexible dosing changes while maintaining a minimum of 4 days between doses. Conclusion: Somapacitan 0.24 mg/kg/week produced similar IGF-I SDS changes and height velocity increases as daily GH in prepubertal short children and adolescents born SGA or with ISS, NS, or TS. The results support that the guidance already established for GHD regarding somapacitan initiation, dosing flexibility, and IGF-I monitoring remain appropriate for prepubertal short children and adolescents born SGA or with ISS, NS, or TS.

Indexed as

idiopathic short statureIGF-I monitoringNoonan syndromesmall for gestational agesomapacitan dosingTurner syndrome

Identifiers

PMID42369274
PMCPMC13306058

What OpenQuestion holds

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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.