Evidence map›Paper›PMID 35014156›Full record

Trial reportDiabetes, obesity & metabolism2022

Inhibition of 11β-Hydroxysteroid dehydrogenase-1 with AZD4017 in patients with nonalcoholic steatohepatitis or nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled, phase II study.

Yogesh Yadav, Kelly Dunagan, Rachita Khot, Sudhakar K Venkatesh, John Port, Alfonso Galderisi, Claudio Cobelli, Craig Wegner, Ananda Basu, Rickey Carter and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.6field-weighted citation impact, top 7% 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.

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

12 citing papers in PubMed, 24 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

11 authors at 6 institutions in 3 countries.

Yogesh YadavDivision of Endocrinology, University of Virginia, Charlottesville, Virginia, USA.
Kelly DunaganDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Rachita KhotDivision of Body Imaging, Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, Virginia, USA.
Sudhakar K VenkateshDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
John PortDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Alfonso GalderisiDepartment of Woman and Child's health, University of Padova, Padova, Veneto, Italy.
Claudio CobelliDepartment of Woman and Child's health, University of Padova, Padova, Veneto, Italy.
Craig WegnerRetired from Emerging & Open Innovations Unit, IMED Biotech Unit, AstraZeneca, USA.
Ananda BasuDivision of Endocrinology, University of Virginia, Charlottesville, Virginia, USA.ORCID 0000-0002-1646-9749
Rickey CarterDepartment of Quantitative Health Sciences, Mayo Clinic, Jacksonville, Florida, USA.
Rita BasuDivision of Endocrinology, University of Virginia, Charlottesville, Virginia, USA.ORCID 0000-0002-7827-9422
Mayo Clinic · USUniversity of Virginia · USUniversity of Padua · ITAstraZeneca (Poland) · PLMayo Clinic in Florida · USUniversity of Virginia Medical Center · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Vanderbilt Diabetes Research CenterP30DK020593 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ALVIN C POWERS · 2012 to 2026
$29.3M
Vanderbilt Mouse Metabolic Physiology CenterU24DK059637 · NIDDK · VANDERBILT UNIVERSITY · PI WASSERMAN, DAVID H · 2001 to 2015
$14.9M
MECHANISMS OF INSULIN RESISTANCE IN MANR01DK029953 · NIDDK · UNIVERSITY OF VIRGINIA · PI BASU, RITA · 1986 to 2024
$11.5M
Integrated Approaches to Close the Loop in Type 1 DiabetesR01DK085516 · NIDDK · UNIVERSITY OF VIRGINIA · PI BASU, ANANDA · 2009 to 2021
$6.5M
MECHANISMS OF INSULIN RESISTANCE in ManR37DK029953 · NIDDK · MAYO CLINIC COLL OF MEDICINE, ROCHESTER · PI RIZZA, ROBERT A. · 1996 to 2003
$1.8M
NCATS NIH HHS UL1 TR000135NIDDK NIH HHS P30 DK020593NIDDK NIH HHS R01 DK029953NIDDK NIH HHS R01 DK085516NIDDK NIH HHS R37 DK029953NIDDK NIH HHS U24 DK059637
6 · The paper itself

Abstract

aimTo evaluate whether short-term treatment with a selective 11β-Hydroxysteroid dehydrogenase-1 (11β-HSD1) inhibitor, AZD4017, would block hepatic cortisol production and thereby decrease hepatic fat in patients with nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH), with or without type 2 diabetes (T2D). MATERIALS AND

methodsThis was a randomized, double-blind, placebo-controlled, phase 2 study conducted at two sites. Key inclusion criteria were the presence of NAFLD or NASH on magnetic resonance imaging (MRI) or recent biopsy positive for NASH. Enrolled patients were randomly assigned (1:1) to AZD4017 or placebo for 12 weeks. Primary outcomes were between-group differences in mean change from baseline to week 12 in liver fat fraction (LFF) and conversion of

resultsA total of 93 patients were randomized; 85 patients completed treatment. The mean (standard deviation [SD]) change in LFF was -0.667 (5.246) and 0.139 (4.323) in the AZD4017 and placebo groups (P = 0.441). For patients with NASH and T2D, the mean (SD) change in LFF was significantly improved in the AZD4017 versus the placebo group (-1.087 [5.374] vs. 1.675 [3.318]; P = 0.033). Conversion of

conclusionAlthough the study did not meet one of the primary outcomes, AZD4017 blocked the conversion of

Indexed as

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease11-beta-Hydroxysteroid Dehydrogenase Type 1Double-Blind MethodHumansLiverNiacinamidePiperidines11-beta-Hydroxysteroid Dehydrogenase Type 12-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acidNiacinamidePiperidines

Identifiers

PMID35014156
PMCPMC9135169
OpenAlexW4206502078

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.