Evidence map›Paper›PMID 34621052›Full record

Trial reportNature medicine2021

Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial.

V Ratziu, L de Guevara, R Safadi, F Poordad, F Fuster, J Flores-Figueroa, M Arrese, Anna L Fracanzani, D Ben Bashat, K Lackner and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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 NCT02279524 (A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis), which is not on this map. Cited by 124 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 2 pooled it
23.1field-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.

NCT02279524 phase2completednot on this map

A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) - Aramchol 005 Study

TypeinterventionalSponsorGalmed Research and Development, Ltd.Ran2015 to 2018Enrolled247ConditionsFatty Liver, Non-Alcoholic Steatohepatitis, Liver Diseases, Liver FibrosesArmsAramchol
3 · Its place in the literature

Who cites it

124 citing papers in PubMed, 2 syntheses or guidelines pooled it, 209 citations in OpenAlex.

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64 more citing papers are in PubMed but not listed here.

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

19 authors at 20 institutions in 12 countries.

V RatziuSorbonne Université, Institute for Cardiometabolism and Nutrition and Hôpital Pitié- Salpêtrière, INSERM UMRS 1138 CRC, Paris, France. vlad.ratziu@inserm.fr.ORCID http://orcid.org/0000-0002-6865-3791
L de GuevaraHospital Ángeles Clínica Londres, Mexico City, Mexico.
R SafadiHadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem. The Holy Family Hospital, Nazareth, Israel.
F PoordadTexas Liver Institute/UT Health San Antonio San Antonio, San Antonio, TX, USA.
F FusterCentro de Investigaciones Clinicas Viña del Mar, Viña del Mar, Chile.
J Flores-FigueroaJM Research, Cuernavaca, Mexico.
M ArreseDepartamento de Gastroenterología Facultad de Medicina Pontificia Universidad Católica de Chile Santiago Chile and Centro de Envejecimiento y Regeneración, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
Anna L FracanzaniDepartment of Internal Medicine, Ca' Granda IRCCS Foundation, Policlinico Maggiore Hospital, University of Milan, Milan, Italy.
D Ben BashatSagol Brain Institute, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine & Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.
K LacknerInstitute of Pathology, Medical University of Graz, Graz, Austria.
T GorfineGalmed Pharmaceuticals Ltd, Tel-Aviv, Israel.ORCID http://orcid.org/0000-0003-1790-5124
S KadoshStatexcellence Ltd, Tel-Aviv, Israel.
R OrenGalmed Pharmaceuticals Ltd, Tel-Aviv, Israel.
M HalperinGalmed Pharmaceuticals Ltd, Tel-Aviv, Israel.
L HayardenyGalmed Pharmaceuticals Ltd, Tel-Aviv, Israel.
R LoombaNAFLD Research Center, University of California at San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0002-4845-9991
S FriedmanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID http://orcid.org/0000-0003-1178-6195
ARREST investigator study group
Arun J SanyalDepartment of Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.ORCID http://orcid.org/0000-0001-8682-5748
Galmed Pharmaceuticals (Israel) · ILRambam Health Care Campus · ILVirginia Commonwealth University · USPontificia Universidad Católica de Chile · CLSorbonne Université · FRWestern Galilee Hospital · ILBrooke Army Medical Center · USCalifornia Liver Research Institute · USCedars-Sinai Medical Center · USCentre Hospitalier Universitaire d'Angers · FRCHU Dijon Bourgogne · FRClinical Emergency Hospital Bucharest · ROColumbia University Irving Medical Center · USHospital Clínico de la Universidad de Chile · CLHospital of Lithuanian University of Health Sciences Kaunas Clinics · LTInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXMedizinische Hochschule Hannover · DEOrange County Research Center · USPoliclinico Umberto I · ITProfil Institute for Clinical Research · US

Funding

Hepatic stellate cells in NASH fibrosis and HCCR01DK128289 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI SCOTT L. FRIEDMAN · 2021 to 2026
$2.6M
NIDDK NIH HHS R01 DK128289
6 · The paper itself

Abstract

Nonalcoholic steatohepatitis (NASH), a chronic liver disease without an approved therapy, is associated with lipotoxicity and insulin resistance and is a major cause of cirrhosis and hepatocellular carcinoma. Aramchol, a partial inhibitor of hepatic stearoyl-CoA desaturase (SCD1) improved steatohepatitis and fibrosis in rodents and reduced steatosis in an early clinical trial. ARREST, a 52-week, double-blind, placebo-controlled, phase 2b trial randomized 247 patients with NASH (n = 101, n = 98 and n = 48 in the Aramchol 400 mg, 600 mg and placebo arms, respectively; NCT02279524 ). The primary end point was a decrease in hepatic triglycerides by magnetic resonance spectroscopy at 52 weeks with a dose of 600 mg of Aramchol. Key secondary end points included liver histology and alanine aminotransferase (ALT). Aramchol 600 mg produced a placebo-corrected decrease in liver triglycerides without meeting the prespecified significance (-3.1, 95% confidence interval (CI) -6.4 to 0.2, P = 0.066), precluding further formal statistical analysis. NASH resolution without worsening fibrosis was achieved in 16.7% (13 out of 78) of Aramchol 600 mg versus 5% (2 out of 40) of the placebo arm (odds ratio (OR) = 4.74, 95% CI = 0.99 to 22.7) and fibrosis improvement by ≥1 stage without worsening NASH in 29.5% versus 17.5% (OR = 1.88, 95% CI = 0.7 to 5.0), respectively. The placebo-corrected decrease in ALT for 600 mg was -29.1 IU l

Indexed as

Alanine TransaminaseBiopsyCholic AcidsDouble-Blind MethodFemaleHumansLiverMagnetic Resonance SpectroscopyMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseStearoyl-CoA DesaturaseTriglyceridesAlanine TransaminasearamcholCholic AcidsSCD1 protein, humanStearoyl-CoA DesaturaseTriglycerides

Identifiers

PMID34621052
PMCPMC12165723
OpenAlexW3203570622

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.