First-of-its-kind study highlights the critical role of essential phospholipids in improving Fatty Liver Disease.

< 21 April 2026 – Opella > - A new study has established that treatment with essential phospholipids (Essentiale) resulted in a 2.5 times greater reduction in liver fat, significant improvement in fatigue and improvement of glycaemic control in individuals with Metabolic dysfunction–Associated Steatotic Liver Disease (MASLD) – also known as ‘Fatty Liver Disease’ – than diet and exercise alone.

The results were found by the EXCEL clinical trial – a multi-centre, randomized, double-blind, placebo-controlled study and the first of its kind to test essential phospholipids (EPLs). The study population comprised a cohort of patients with MASLD in Germany and Poland, focusing on individuals who, along with Fatty Liver Disease, also presented with at least one common metabolic comorbidity, such as type 2 diabetes, hyperlipidaemia, or obesity.

MASLD is the most prevalent chronic liver disease worldwide, affecting an estimated 30% of the adult population, with projections indicating over 55% of adults worldwide will be affected by MASLD by 2040^[1]. 

While often considered a “silent” condition, fatty liver disease is frequently associated with a debilitating constellation of symptoms such as abdominal pain, fatigue, sleep issues, bloating, depressive symptoms, anxiety and metabolic risks.

Professor Norbert Stefan, Holder of the Chair of Clinical and Experimental Diabetology at the University of Tübingen.

“This groundbreaking research marks an important moment for the millions of people currently living with MASLD. The EXCEL study underscores the clinical importance of early intervention and bridges the gap between scientific evidence and patient experience. By demonstrating measurable improvements in liver fat reduction and improvement of fatigue, this study reinforces the vital message that effective, evidence-based options exist to transform outcomes and restore hope for a more energized life in people with MASLD.”

Holistic Disease Impact: Beyond Biochemical Markers

The EXCEL study used modern, non-invasive imaging to measure liver fat alongside a validated, disease-specific questionnaire to assess the treatment’s impact on patient wellbeing. The main trial results showed that, when used in addition to diet and exercise, essential phospholipids were associated with:

A 2.5 times greater reduction in liver fat compared with lifestyle intervention alone, as measured by FibroScan CAP (Controlled Attenuation Parameter).

A statistically significant improvement in patient-reported fatigue, a primary and often overlooked symptom of MASLD. This outcome was formally assessed using the validated CLDQ-MASLD score, a standardized measure of well-being in individuals with chronic liver disease.

The study also noted that treatment with EPLs significantly reduced HbA1c levels, a key marker for glycemic control in patients with type 2 diabetes, making the findings particularly relevant for the large percentage of MASLD patients with co-existing metabolic conditions.

Nikunj Thakker Global Brand General Manager Essentiale, Opella.

“The new Phase 4 randomized, placebo-controlled EXCEL study proves that timing is everything. When caught early, a significant portion of MASLD cases can be reversible. This evidence-based treatment, using essential phospholipids combined with diet and exercise, actively reduces liver fat and tackles debilitating fatigue head-on, changing outcomes for the billions globally living with Fatty Liver Disease.”

A New Benchmark

The EXCEL study’s robust methodology provides a new level of clinical evidence for the management of MASLD. Its findings offer clinicians a well-tolerated and effective intervention grounded in rigorous scientific data.

Key Findings:

• Liver fat reduction: A statistically significant reduction in CAP scores (p=0.0269) versus placebo at 6 months.
• In addition, in patients with more severe steatosis, Essentiale provided better reduction of liver fat at month 6.

1. Improved fatigue scores: A significant improvement in fatigue sub-scores from the CLDQ-MASLD questionnaire (p=0.0229) at month 6.

1. Metabolic benefits: A significant reduction in HbA1c compared to placebo at month 6 (p=0.0069).

1. Safety profile: Comparable safety and tolerability to placebo.

Informing the Future of MASLD Management

By providing high-quality data on both objective and patient-reported outcomes, the EXCEL study may help to reframe the early stage of MASLD as a measurable and manageable condition. This evidence supports healthcare professionals in applying a more proactive and holistic approach to care that aligns with clinical guidelines and addresses the real-world patient experience.

The full study methodology and findings were recently published in Liver International and can be accessed here: https://onlinelibrary.wiley.com/doi/10.1111/liv.70601.

About Opella.

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.  Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified globally, we are active players in the journey towards healthier people and planet.

Find out more about our mission at www.opella.com.

About Essentiale. 

Essentiale is a globally recognised liver health product formulated with essential phospholipids derived from highly purified soybean. Rich in phosphatidylcholine, these phospholipids support the structural integrity of liver cell membranes and the organ’s natural metabolic processes. Essentiale is used in many markets around the world to support liver health and address functional symptoms associated with liver stress. The brand is part of Opella’s portfolio of consumer health solutions that aim to make self-care simple and effective. 

[1]  Bellentani S., Scaglioni F., Marino M., and Bedogni G., “Epidemiology of Non‐Alcoholic Fatty Liver Disease,” Digestive Diseases 28, no. 1 (2010): 155–161.