Evidence map›Paper›PMID 36062966›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

Bradley S Miller, Joanne C Blair, Michael Højby Rasmussen, Aristides Maniatis, Rasmus Juul Kildemoes, Jun Mori, Michel Polak, Rikke Beck Bang, Volker Böttcher, Stefano Stagi and 1 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03811535 (A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency), which is not on this map. Cited by 51 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 6 pooled it
7.4field-weighted citation impact, top 2% of its field
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.

NCT03811535 phase3completednot on this map

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

TypeinterventionalSponsorNovo Nordisk A/SRan2019 to 2025Enrolled200ConditionsGrowth Hormone Deficiency in ChildrenArmsSomapacitan, Norditropin®
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 6 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 7 countries.

Bradley S MillerDivision of Pediatric Endocrinology, University of Minnesota Masonic Children's Hospital, Minneapolis, MN 55454, USA.ORCID 0000-0003-3663-5473
Joanne C BlairDepartment of Endocrinology, Alder Hey Children's NHS Foundation Trust, Liverpool, L14 5AB, UK.
Michael Højby RasmussenNovo Nordisk A/S, Søborg, 2860, Denmark.ORCID 0000-0002-2210-0366
Aristides ManiatisRocky Mountain Pediatric Endocrinology, Centennial, 80112 CO, USA.
Rasmus Juul KildemoesNovo Nordisk A/S, Søborg, 2860, Denmark.
Jun MoriDivision of Pediatric Endocrinology and Metabolism, Children's Medical Center, Osaka City General Hospital, Osaka 534-0021, Japan.ORCID 0000-0002-1271-1577
Michel PolakService d'Endocrinologie, Gynécologie et Diabétologie Pédiatriques, Hôpital Universitaire Necker Enfants Malades Paris, Assistance Publique-Hôpitaux de Paris, Paris 75015, France.ORCID 0000-0003-2639-352X
Rikke Beck BangNovo Nordisk A/S, Aalborg 9220, Denmark.
Volker BöttcherDivision of Pediatric Endocrinology and Metabolism, MVZ Endokrinologikum Frankfurt am Main, Frankfurt 60596, Germany.
Stefano StagiDepartment of Health Sciences, University of Florence, Anna Meyer Children's University Hospital, Florence 50139, Italy.
Reiko HorikawaDivision of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo 157-0074, Japan.ORCID 0000-0003-3429-3246
Novo Nordisk (Denmark) · DKAlder Hey Children's NHS Foundation Trust · GBEndokrinologikum · DEHôpital Necker-Enfants Malades · FRMeyer Children's Hospital · ITNational Center For Child Health and Development · JPOsaka City General Hospital · JPRocky Mountain Diabetes and Osteoporosis Center · USUniversity of Minnesota Children's Hospital · US

Funding

Novo Nordisk
6 · The paper itself

Abstract

contextSomapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in children with GH deficiency (GHD).

objectiveTo demonstrate efficacy and safety of somapacitan vs daily GH.

methodsREAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).

settingEighty-six sites across 20 countries. PATIENTS: 200 treatment-naïve patients were randomized and exposed.

interventionsPatients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.

main outcome measuresThe primary endpoint was annualized height velocity (HV; cm/y) at week 52. Additional assessments included HV SD score (SDS), height SDS, bone age, IGF-I SDS, patient-reported outcomes, and safety measures.

resultsEstimated mean HV at week 52 was 11.2 and 11.7 cm/y for somapacitan and daily GH, respectively. Noninferiority was confirmed. Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups. At week 52, mean IGF-I SDS values were similar between treatment groups and within normal range (-2 to +2). Safety of somapacitan was consistent with the well-known daily GH profile. Low proportions of injection-site reactions were reported for somapacitan (5.3%) and daily GH (5.9%). Both treatments similarly reduced disease burden from baseline to week 52, whereas a greater treatment burden reduction was observed for somapacitan.

conclusionsSimilar efficacy for somapacitan compared to daily GH was demonstrated over 52 weeks of treatment with comparable safety and mean IGF-I SDS levels in treatment-naïve children with GHD.

Indexed as

Dwarfism, PituitaryHuman Growth HormoneChildGrowth HormoneHistidineHumansInsulin-Like Growth Factor IMannitolPhenolGrowth HormoneHistidineHuman Growth HormoneInsulin-Like Growth Factor IMannitolPhenolsomapacitangrowth hormonegrowth hormone deficiencygrowth hormone replacement therapylong-acting growth hormonesomapacitantreatment burden

Identifiers

PMID36062966
PMCPMC9693810
OpenAlexW4294670647

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.