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Essential Phospholipids Reduce Hepatic Steatosis and Improve Glycaemic Control in MASLD
In a double-blind, placebo-controlled trial, essential phospholipid (EPL) treatment significantly reduced hepatic steatosis measured by Controlled Attenuation Parameter (CAP) score compared with placebo at six months (p = 0.0269), alongside improvements in fatigue and HbA1c levels in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). These findings add randomised controlled evidence supporting EPL as a potential pharmacological adjunct to standard care in a therapeutic area where approved drug options remain scarce.
What Was Studied
The trial investigated whether essential phospholipids, added to standard of care, could meaningfully reduce liver fat accumulation — quantified by the Controlled Attenuation Parameter (CAP) score — over six months in patients with MASLD who also carried cardiometabolic risk factors. Secondary and exploratory objectives assessed quality of life, fatigue, glycaemic markers, and broader metabolic and lipid parameters, reflecting the multisystem burden of this condition.
How It Was Studied
This was a multicentre, double-blind, randomised, placebo-controlled Phase 4 clinical trial enrolling adults diagnosed with MASLD who also had at least one of the following comorbidities: type 2 diabetes, hyperlipidaemia, or obesity. A total of 193 patients were randomised, with 165 included in the modified intention-to-treat analysis — the population used for primary efficacy evaluation. Participants were assigned to receive either EPL or matching placebo on top of standard of care for six months, with a follow-up assessment conducted three months after treatment completion. The median age was 56.5 years in the EPL arm and 55.0 years in the placebo arm; more than three-quarters of the study population were obese and had a baseline CAP score at or above 280 dB/m, indicating moderate-to-severe steatosis.
What Was Observed
- Hepatic steatosis reduction: EPL treatment produced a statistically significant reduction in CAP score compared with placebo by six months (p = 0.0269). Importantly, this effect was already detectable at the three-month interim assessment (p = 0.0049) and remained statistically significant three months after treatment ended (p = 0.0234), suggesting a durable biological effect beyond the active treatment period. The abstract does not report the absolute magnitude of CAP change or confidence intervals, limiting precise quantification of clinical effect size.
- Quality of life and fatigue: Although the overall quality-of-life total score (measured by the CLDQ-MASLD questionnaire) showed a numerical improvement in the EPL group, it did not reach statistical significance. However, the fatigue subscale specifically demonstrated a statistically significant improvement with EPL versus placebo at six months (p = 0.0229), pointing to a meaningful symptomatic benefit in a domain that commonly impairs daily functioning in MASLD patients.
- Glycaemic control: EPL significantly improved HbA1c levels over the six-month treatment period compared with placebo (p = 0.0069), indicating a beneficial effect on long-term blood glucose regulation. This finding is particularly relevant given that type 2 diabetes was one of the defining comorbidities in the enrolled population.
- Safety: No safety concerns were identified during the trial, and the tolerability profile of EPL was described as favourable across the study period.
Why This Matters
MASLD affects a large and growing proportion of the global population, yet no pharmacological agents have achieved widespread regulatory approval specifically for this indication. This trial provides randomised, placebo-controlled evidence that EPL can reduce liver fat, improve a patient-relevant symptom such as fatigue, and benefit glycaemic control simultaneously — addressing several dimensions of disease burden in one intervention. These results justify further investigation into EPL, including larger trials with histological endpoints, to determine its role in the MASLD treatment landscape.
How to Read This Result
While the positive direction of findings across multiple endpoints is encouraging, the absence of reported effect sizes and confidence intervals in the abstract limits precise assessment of clinical meaningfulness, and the modest sample size warrants cautious interpretation pending replication in larger cohorts.
Limitations
The abstract does not explicitly report study limitations.