Evidence mapPaperPMID 41889076Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2026

Effect of Essential Phospholipids in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Phase 4 Clinical Trial.

Norbert Stefan, Marek Hartleb, Jiangao Fan, Münevver Demir, Jörn M Schattenberg, Jan Gietka, Łukasz Bułdak, Branko Popovic, Rafael Varona, Beatrice Bois De Fer

Abstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
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

1 citing paper in PubMed.

  1. Effect of Essential Phospholipids in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Phase 4 Clinical Trial.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Trial
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

10 authors.

Norbert StefanDepartment of Internal Medicine IV, University Hospital Tübingen, Tübingen, Germany.ORCID 0000-0002-2186-9595
Marek HartlebDepartment of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland.
Jiangao FanDepartment of Gastroenterology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Münevver DemirDepartment of Hepatology and Gastroenterology, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Berlin, Germany.
Jörn M SchattenbergDepartment of Internal Medicine II, Saarland University Medical Center, Homburg, Germany.ORCID 0000-0002-4224-4703
Jan GietkaHepatolodzy Outpatient Clinic, Warsaw, Poland.
Łukasz BułdakDepartment of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.
Branko PopovicOpella Healthcare, A. Nattermann & Cie. GmbH, Frankfurt am Main, Germany.
Rafael VaronaOpella Healthcare Group SAS, Neuilly-sur-Seine, France.
Beatrice Bois De FerOpella Healthcare Group SAS, Neuilly-sur-Seine, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMetabolic dysfunction-associated steatotic liver disease (MASLD) poses a significant health burden and impacts quality of life (QoL). This study evaluates the effects of essential phospholipids (EPL) on liver steatosis, QoL, and other liver and metabolic parameters in patients with MASLD and associated comorbidities.

methodsIn this multicenter, double-blind, randomised, placebo-controlled phase 4 clinical trial, patients with MASLD and type 2 diabetes, hyperlipidemia, or obesity received either EPL or placebo, alongside standard of care. PRIMARY ENDPOINT: change in hepatic steatosis from baseline to 6 months (measured by Controlled Attenuation Parameter [CAP] score); secondary endpoints: changes in QoL (measured by the Chronic Liver Disease Questionnaire [CLDQ-MASLD]), symptom changes; other endpoints: other liver, metabolic, and lipid parameters, and safety.

resultsOf 193 randomised patients, 165 constituted the modified intention-to-treat population (median age: 56.5 years [EPL arm], 55.0 years [placebo arm]). More than ¾ of patients were obese and had CAP score ≥ 280 dB/m. At 6 months, EPL treatment significantly reduced CAP (p = 0.0269) versus placebo. This effect was evident at 3 months (p = 0.0049) and sustained until 3 months post treatment (p = 0.0234). QoL total score showed numerical improvement, with statistically significant improvement in fatigue subscore (p = 0.0229) with EPL versus placebo at 6 months. EPL significantly improved HbA1c levels (p = 0.0069) over 6 months. No safety concerns arose.

conclusionsThe beneficial effects of EPL on hepatic steatosis, QoL and glycemic control, and its favourable safety profile make it a promising candidate for managing steatosis and enhancing overall liver health in MASLD patients with cardiometabolic risk.

trial registrationThe trial was registered in the EudraCT (2021-006069-39).

Indexed as

Fatty LiverNon-alcoholic Fatty Liver DiseasePhospholipidsAdultAgedDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansHyperlipidemiasMaleMiddle AgedObesityQuality of LifeTreatment OutcomePhospholipidsadjunctive therapyfatiguehaemoglobin A1c (HbA1c)hepatic steatosisquality of life

Identifiers

PMID41889076
PMCPMC13022469

What Socratic holds

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Registered trials

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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.