Evidence map›Paper›PMID 34127852›Full record

Trial reportNature medicine2021

Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial.

Aditi R Saxena, Donal N Gorman, Ryan M Esquejo, Arthur Bergman, Kristin Chidsey, Clare Buckeridge, David A Griffith, Albert M Kim

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03538743 (A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS), which is not on this map. Cited by 59 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 4 pooled it
14.2field-weighted citation impact, top 1% 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.

NCT03538743 phase1completednot on this map

A phase 1, randomized, double-blind, sponsor-open, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple escalating oral doses of pf-06882961 in adult subjects with type 2 diabetes mellitus

TypeinterventionalSponsorPfizerRan2018 to 2019Enrolled98ConditionsType 2 Diabetes MellitusArmsPlacebo, PF-06882961
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 4 syntheses or guidelines pooled it, 135 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Aditi R SaxenaPfizer Worldwide Research and Development, Cambridge, MA, USA. aditi.saxena@pfizer.com.ORCID http://orcid.org/0000-0001-6017-1838
Donal N GormanPfizer Worldwide Research and Development, Cambridge, UK.ORCID http://orcid.org/0000-0003-4853-9817
Ryan M EsquejoPfizer Worldwide Research and Development, Cambridge, MA, USA.
Arthur BergmanPfizer Worldwide Research and Development, Cambridge, MA, USA.
Kristin ChidseyPfizer Worldwide Research and Development, Cambridge, MA, USA.
Clare BuckeridgePfizer Worldwide Research and Development, Cambridge, MA, USA.
David A GriffithPfizer Worldwide Research and Development, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-7592-2478
Albert M KimPfizer Worldwide Research and Development, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-5269-2155
Pfizer (United States) · USPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Agonism of the glucagon-like peptide-1 receptor (GLP-1R) results in glycemic lowering and body weight loss and is a therapeutic strategy to treat type 2 diabetes (T2D) and obesity. We developed danuglipron (PF-06882961), an oral small-molecule GLP-1R agonist and found it had comparable efficacy to injectable peptidic GLP-1R agonists in a humanized mouse model. We then completed a placebo-controlled, randomized, double-blind, multiple ascending-dose phase 1 study ( NCT03538743 ), in which we enrolled 98 patients with T2D on background metformin and randomized them to receive multiple ascending doses of danuglipron or placebo for 28 d, across eight cohorts. The primary outcomes were assessment of adverse events (AEs), safety laboratory tests, vital signs and 12-lead electrocardiograms. Most AEs were mild, with nausea, dyspepsia and vomiting most commonly reported. There were no clinically meaningful AEs in laboratory values across groups. Heart rate generally increased with danuglipron treatment at day 28, but no heart-rate AEs were reported. Systolic blood pressure was slightly decreased and changes in diastolic blood pressure were similar with danuglipron treatment at day 28, compared with placebo. There were no clinically meaningful electrocardiogram findings. In this study in T2D, danuglipron was generally well tolerated, with a safety profile consistent with the mechanism of action of GLP-1R agonism.

Indexed as

AnimalsBlood GlucoseBody WeightDiabetes Mellitus, Type 2FemaleGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHumansHypoglycemic AgentsMaleMetforminMiceMiddle AgedObesityBlood GlucoseGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsMetformin

Identifiers

PMID34127852
OpenAlexW3166038843

What OpenQuestion holds

Texttitle and abstract
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.