Evidence map›Paper›PMID 29992370›Full record

Trial reportDiabetologia2018

Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial.

Joseph Proietto, Jaret Malloy, Dongliang Zhuang, Mark Arya, Neale D Cohen, Ferdinandus J de Looze, Christopher Gilfillan, Paul Griffin, Stephen Hall, Thomas Nathow and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02324491 (Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.0field-weighted citation impact, top 20% 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.

NCT02324491 phase2terminatednot on this map

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Weight Reduction, Glycemic Control, Safety, and Tolerability

TypeinterventionalSponsorZafgen, Inc.Ran2014 to 2015Enrolled152ConditionsObesity, Type 2 DiabetesArmsZGN-440 for Injectable Suspension, ZGN-440 Placebo for Injectable Suspension
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Obesity medications in development.Expert opinion on investigational drugs · 2020
    Review
  8. Article
  9. 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

17 authors at 12 institutions in 2 countries.

Joseph ProiettoDepartment of Medicine (Austin Health), University of Melbourne, Heidelberg, VIC, Australia.
Jaret MalloyZafgen, Inc., 175 Portland St, 4th Floor, Boston, MA, 02114, USA.
Dongliang ZhuangZafgen, Inc., 175 Portland St, 4th Floor, Boston, MA, 02114, USA.
Mark AryaAustralian Clinical Research Network, Maroubra, NSW, Australia.
Neale D CohenBaker Heart and Diabetes Institute, Melbourne, VIC, Australia.
Ferdinandus J de LoozeAusTrials Pty Ltd, Sherwood, QLD, Australia.
Christopher GilfillanEastern Health Clinical School, Monash University, Box Hill, VIC, Australia.
Paul GriffinQ-Pharm Pty Ltd, Herston, QLD, Australia.
Stephen HallEmeritus Research, Malvern East, VIC, Australia.
Thomas NathowIpswich Research Institute, Ipswich, QLD, Australia.
Geoffrey S OldfieldPendlebury Research, Cardiff, NSW, Australia.
David N O'NealDepartment of Medicine, University of Melbourne, St Vincent's Hospital, Fitzroy, VIC, Australia.
Adam RobertsUniversity Hospital Geelong, Geelong, VIC, Australia.
Bronwyn G A StuckeyKeogh Institute for Medical Research, University of Western Australia, Nedlands, WA, Australia.
Dennis YueRoyal Prince Alfred Hospital, Camperdown, NSW, Australia.
Kristin TaylorZafgen, Inc., 175 Portland St, 4th Floor, Boston, MA, 02114, USA.
Dennis KimZafgen, Inc., 175 Portland St, 4th Floor, Boston, MA, 02114, USA. dkim@zafgen.com.
Zafgen (United States) · USMonash University · AUAustin Health · AUBaker Heart and Diabetes Institute · AUBreast Cancer Network Australia · AUGeelong Hospital · AUIpswich Hospital · AUQIMR Berghofer Medical Research Institute · AURoyal Prince Alfred Hospital · AUUniversity of Melbourne · AUUniversity of Queensland · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThis multicentre randomised double-blind placebo-controlled clinical trial assessed the efficacy and safety of a methionine aminopeptidase 2 (MetAP2) inhibitor, beloranib, in individuals with obesity (BMI ≥30 kg/m

methodsParticipants were randomised (via a centralised interactive web response system) to placebo, 1.2 or 1.8 mg beloranib s.c. twice weekly for 26 weeks. Participants, investigators and the sponsor were blinded to group assignment. The primary endpoint was the change in weight from baseline to week 26. The trial was terminated early when beloranib development was stopped because of an imbalance of venous thromboembolism events in beloranib-treated individuals vs placebo that became evident during late-stage development of the drug.

resultsIn total, 153 participants were randomised, 51 to placebo, 52 to 1.2 mg beloranib and 50 to 1.8 mg beloranib. In participants who completed week 26, the least squares mean ± SE weight change (baseline 111 kg) was -3.1 ± 1.2% with placebo (n = 22) vs -13.5 ± 1.1% and -12.7 ± 1.3% with 1.2 and 1.8 mg beloranib, respectively (n = 25; n = 19; p < 0.0001). The change in HbA CONCLUSIONS/

interpretationMetAP2 inhibitors represent a novel mechanism for producing meaningful weight loss and improvement in HbA

trial registrationClinicalTrials.gov NCT02324491

fundingThe study was funded by Zafgen, Inc.

Indexed as

AdolescentAdultAgedAminopeptidasesAnti-Obesity AgentsBlood GlucoseBody WeightCinnamatesCyclohexanesDiabetes Mellitus, Type 2Double-Blind MethodEpoxy CompoundsFemaleGlucoseGlycated HemoglobinGlycoproteinsAminopeptidasesAnti-Obesity AgentsBlood GlucoseCinnamatesCKD732CyclohexanesEpoxy CompoundsGlucoseGlycated HemoglobinGlycoproteinsHypoglycemic AgentsMetalloendopeptidasesMETAP2 protein, humanmethionine aminopeptidase 2Methionyl AminopeptidasesSesquiterpenesAnti-obesity medicationGlucose-lowering medicationGlycaemic controlMetAP2

Identifiers

PMID29992370
OpenAlexW2876920643

What OpenQuestion holds

Textmetadata
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.