Evidence map›Paper›PMID 32022863›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2020

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

Gudmundur Johannsson, Murray B Gordon, Michael Højby Rasmussen, Ida Holme Håkonsson, Wolfram Karges, Claus Sværke, Shigeyuki Tahara, Koji Takano, Beverly M K Biller

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02229851 (A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled), which is not on this map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT02229851 phase3completednot on this map

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

TypeinterventionalSponsorNovo Nordisk A/SRan2014 to 2018Enrolled301ConditionsGrowth Hormone Disorder, Adult Growth Hormone DeficiencyArmssomapacitan, somatropin, placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 72 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

9 authors at 7 institutions in 5 countries.

Gudmundur JohannssonSahlgrenska University Hospital, Göteborg, Sweden.
Murray B GordonAllegheny General Hospital, Pittsburgh, PA.
Michael Højby RasmussenNovo Nordisk A/S, Søborg, Denmark.
Ida Holme HåkonssonNovo Nordisk A/S, Søborg, Denmark.
Wolfram KargesDivision of Endocrinology and Diabetes, RWTH Aachen University, Aachen, Germany.
Claus SværkeNovo Nordisk A/S, Søborg, Denmark.
Shigeyuki TaharaNippon Medical School, Tokyo, Japan.
Koji TakanoDepartment of Endocrinology, Diabetes and Metabolism, Kitasato University, Tokyo, Japan.
Beverly M K BillerNeuroendocrine Unit, Massachusetts General Hospital, Boston, MA.
Novo Nordisk (Denmark) · DKAllegheny General Hospital · USKitasato University · JPMassachusetts General Hospital · USNippon Medical School · JPRWTH Aachen University · DESahlgrenska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextGrowth hormone (GH) replacement requires daily GH injections, which is burdensome for some adult patients with GH deficiency (AGHD).

objectiveTo demonstrate efficacy and safety of somapacitan, a once-weekly reversible albumin-binding GH derivative, versus placebo in AGHD.

designRandomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).

settingClinics in 17 countries. PATIENTS: Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.

interventionsPatients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period). During the 52-week extension period, patients continued treatment with somapacitan or daily GH.

main outcome measuresBody composition measured using dual-energy x-ray absorptiometry (DXA). The primary endpoint was change in truncal fat percentage to week 34. Insulin-like growth factor 1 (IGF-I) standard deviation score (SDS) values were used to dose titrate.

resultsAt 34 weeks, somapacitan significantly reduced truncal fat percentage (estimated difference: -1.53% [-2.68; -0.38]; P = 0.0090), demonstrating superiority compared with placebo, and it improved other body composition parameters (including visceral fat and lean body mass) and IGF-I SDS. At 86 weeks, improvements were maintained with both somapacitan and daily GH. Somapacitan was well tolerated, with similar adverse events (including injection-site reactions) compared with daily GH.

conclusionsIn AGHD patients, somapacitan administered once weekly demonstrated superiority over placebo, and the overall treatment effects and safety of somapacitan were in accordance with known effects and safety of GH replacement for up to 86 weeks of treatment. Somapacitan may provide an effective alternative to daily GH in AGHD. A short visual summary of our work is available (1).

Indexed as

Hormone Replacement TherapyBiomarkersBody CompositionDose-Response Relationship, DrugDouble-Blind MethodDwarfism, PituitaryFemaleFollow-Up StudiesHuman Growth HormoneHumansInsulin-Like Growth Factor IMaleMiddle AgedPrognosisRecombinant ProteinsBiomarkersHuman Growth HormoneIGF1 protein, humanInsulin-Like Growth Factor IRecombinant Proteinsadult growth hormone deficiencybody compositionhypopituitarismlong-acting growth hormoneREAL 1somapacitan

Identifiers

PMID32022863
PMCPMC7076631
OpenAlexW3006518668

What OpenQuestion holds

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LicenceCC BY
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.