Evidence map›Paper›PMID 29500310›Full record

Trial reportEuropean journal of endocrinology2018

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

Gudmundur Johannsson, Ulla Feldt-Rasmussen, Ida Holme Håkonsson, Henrik Biering, Patrice Rodien, Shigeyuki Tahara, Andrew Toogood, Michael Højby Rasmussen, REAL 2 Study Group

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of endocrinology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Systematic Literature Review of Outcomes Associated With Adherence to Haemophilia Drug Therapy.Haemophilia : the official journal of the World Federation of Hemophilia · 2025
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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.

Gudmundur JohannssonUniversity of Göteborg and Sahlgrenska University HospitalGöteborg, Sweden.
Ulla Feldt-RasmussenRigshospitaletCopenhagen, Denmark.
Ida Holme HåkonssonGlobal DevelopmentNovo Nordisk A/S, Søborg, Denmark.
Henrik BieringMediCover Berlin-Mitte MVZBerlin, Germany.
Patrice RodienReference Centre for Rare Diseases of Thyroid and Hormone ReceptorsMember of EndoERN Network, CHU Angers Centre Hospitalier Universitaire, Angers, France.
Shigeyuki TaharaNippon Medical SchoolTokyo, Japan.
Andrew ToogoodQueen Elizabeth Hospital BirminghamBirmingham, UK.
Michael Højby RasmussenGlobal DevelopmentNovo Nordisk A/S, Søborg, Denmark.
REAL 2 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSomapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin

design26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).

methodsMale or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (

resultsMean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (

conclusionsIn this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.

Indexed as

AdultAgedCholelithiasisDrug Administration ScheduleDwarfism, PituitaryFemaleHuman Growth HormoneHumansMaleMiddle AgedSerum AlbuminHuman Growth HormoneSerum Albumin

Identifiers

PMID29500310
PMCPMC5920019

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Registered trials

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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.