Evidence map›Paper›PMID 34964458›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.

Lars Sävendahl, Tadej Battelino, Michael Højby Rasmussen, Meryl Brod, Paul Saenger, Reiko Horikawa

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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 NCT02616562 (A Randomised, Multinational, Active-controlled,), which is not on this map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
4.4field-weighted citation impact, top 4% 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.

NCT02616562 phase2completednot on this map

A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2024Enrolled76ConditionsGrowth Hormone Disorder, Growth Hormone Deficiency in ChildrenArmssomapacitan, Norditropin® FlexPro® pen
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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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

6 authors at 5 institutions in 5 countries.

Lars SävendahlDepartment of Women's and Children's Health, Karolinska Institutet and Pediatric Endocrinology Unit, Karolinska University Hospital, Solna 171 64, Sweden.ORCID 0000-0003-1067-4976
Tadej BattelinoUniversity Medical Center Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana 1000, Slovenia.ORCID 0000-0002-0273-4732
Michael Højby RasmussenNovo Nordisk, Clinical Drug Development, Søborg 2860, Denmark.
Meryl BrodThe Brod Group, Mill Valley, CA 94941, USA.
Paul SaengerNYU Langone Health, Mineola, NY 11501, USA.
Reiko HorikawaNational Center for Child Health and Development, Tokyo 157-8535, Japan.
Brod Group · USKarolinska University Hospital · SENational Center For Child Health and Development · JPNovo Nordisk (Denmark) · DKUniversity of Ljubljana · SI

Funding

Novo Nordisk
6 · The paper itself

Abstract

contextCurrent GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD).

objectiveEvaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment.

designA multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).

settingTwenty-nine sites in 11 countries. PATIENTS: Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period.

interventionsPatients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.

main outcome measuresHeight velocity (HV) at year 3; changes from baseline in height SD score (HSDS), HVSDS, and IGF-I SDS.

resultsThe estimated treatment difference (95% CI) in HV for somapacitan 0.16/0.16 mg/kg/wk vs daily GH at year 3 was 0.8 cm/y (-0.4 to 2.1). Change in HVSDS from baseline to year 3 was comparable between somapacitan 0.16/0.16 mg/kg/wk, the pooled somapacitan groups, and daily GH. A gradual increase in HSDS from baseline was observed for all groups. At year 3, mean HSDS was similar for the pooled somapacitan groups and daily GH. Change from baseline to year 3 in mean IGF-I SDS was similar across treatments.

conclusionsOnce-weekly somapacitan in children with GHD showed sustained efficacy over 3 years in all assessed height-based outcomes with similar safety and tolerability to daily GH. A plain language summary (1) is available for this study. CLINICAL TRIAL INFORMATION: This study has been registered at ClinicalTrials.gov, number NCT02616562 (REAL 3).

Indexed as

Dwarfism, PituitaryHuman Growth HormonePituitary Hormones, AnteriorBody HeightChildGrowth HormoneHistidineHumansInsulin-Like Growth Factor IMannitolPhenolGrowth HormoneHistidineHuman Growth HormoneInsulin-Like Growth Factor IMannitolPhenolPituitary Hormones, Anteriorsomapacitanchildhood growth hormone deficiencygrowth hormonegrowth hormone deficiencygrowth hormone replacement therapylong-acting growth hormonesomapacitan

Identifiers

PMID34964458
PMCPMC9016428
OpenAlexW4200419475

What OpenQuestion holds

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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.