Evidence map›Paper›PMID 31326433›Full record

Trial reportEBioMedicine2019

Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial.

Rahim Mohammad Naimi, Mark Hvistendahl, Nikolaj Nerup, Rikard Ambrus, Michael Patrick Achiam, Lars Bo Svendsen, Henning Grønbæk, Holger Jon Møller, Hendrik Vilstrup, Adam Steensberg and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02690025 (A Phase 2 Trial Testing ZP1848 in Patients With SBS), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.7field-weighted citation impact, top 18% 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.

NCT02690025 phase2completednot on this map

A Phase 2 Trial Testing ZP1848 in Patients With SBS

TypeinterventionalSponsorZealand PharmaRan2016 to 2017Enrolled18ConditionsShort Bowel SyndromeArmsZP1848
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 28 citations in OpenAlex.

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  14. New insights into intestinal failure-associated liver disease in adults: A comprehensive review of the literature.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Review
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

11 authors at 3 institutions in 1 country.

Rahim Mohammad NaimiDepartment of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark. Electronic address: rahim.mohammad.naimi@regionh.dk.
Mark HvistendahlDepartment of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.
Nikolaj NerupDepartment of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
Rikard AmbrusDepartment of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
Michael Patrick AchiamDepartment of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
Lars Bo SvendsenDepartment of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
Henning GrønbækDepartment of Hepatology & Gastroenterology, Aarhus University Hospital, Denmark.
Holger Jon MøllerDepartment of Clinical Biochemistry, Aarhus University Hospital, Denmark.
Hendrik VilstrupDepartment of Hepatology & Gastroenterology, Aarhus University Hospital, Denmark.
Adam SteensbergResearch & Development, Zealand Pharma, Glostrup, Denmark.
Palle Bekker JeppesenDepartment of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.
Rigshospitalet · DKAarhus University Hospital · DKZealand Pharma (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith the introduction of glucagon-like peptide-2 (GLP-2) in the treatment of short bowel syndrome (SBS), there is emerging evidence that GLP-2 may play a role in the restoration of the disturbed homeostatic feedback in the gut-liver axis and may ameliorate SBS-associated liver damage. We have previously presented that daily subcutaneous injections with 1 and 10 mg of glepaglutide improved intestinal function in patients with SBS. As exploratory endpoints, we here assessed the effect of glepaglutide on liver function.

methodsLiver tests, transient elastography (TE) with controlled attenuation parameter (CAP), indocyanine green (ICG) kinetics, soluble CD163 (sCD163), soluble mannose receptor (sMR), and lipopolysaccharide binding protein (LBP) were assessed in 18 patients with SBS in a randomised, cross-over, dose-finding phase 2 trial before and after three weeks of treatment with glepaglutide. This trial is completed and registered at ClinicalTrials.gov: NCT02690025.

findingsBetween Feb 2016 and Jan 2017, 22 patients with SBS were screened. Of these, 18 patients were randomised and treated with glepaglutide; 16 patients completed the trial. Treatment with glepaglutide was associated with increase in TE and ICG-elimination. In the 10 mg dose group, glepaglutide increased sCD163 by 0·44 mg/mL (P = 0·0498), and alkaline phosphatase (ALP) decreased in the 1 mg dose group by 33 U/L (P = 0·032). CAP, sMR, LBP, liver transaminases, and INR were not affected.

interpretationGlepaglutide may improve hepatic excretory function, but at the same time activate resident liver macrophages and increase liver stiffness. The excretory and the stiffness findings may to some extent relate to increased splanchnic blood flow which would not influence the marker of macrophage activation. Thus, glepaglutide exerted diverse effects on liver status that call for attention in future studies.

fundingZealand Pharma.

Indexed as

AgedBiomarkersDenmarkElasticity Imaging TechniquesFemaleGlucagon-Like Peptide 2HumansLiverMaleMiddle AgedShort Bowel SyndromeTreatment OutcomeBiomarkersGlucagon-Like Peptide 2Indocyanine greenShort bowel syndromeSoluble CD163Soluble mannose receptorTransient elastography

Identifiers

PMID31326433
PMCPMC6710908
OpenAlexW2957503683

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.