In a randomised controlled trial, liraglutide met the primary endpoint of histological clearance of non-alcoholic steatohepatitis, and a reduction in progression of fibrosis

April 23, 2015, Vienna, Austria: A drug approved to treat type 2 diabetes could prove to be a powerful new treatment option for non-alcoholic steatohepatitis (NASH), according to research presented today at The International Liver CongressTM 2015. Results from a randomised controlled trial showed liraglutide met the primary endpoint of histological clearance of NASH, and a reduction in the progression of fibrosis. The research was supported by the Wellcome Trust and the NIHR.

In the Liraglutide Efficacy and Action in NASH (LEAN) trial, overweight patients with biopsy-confirmed NASH were randomised (1:1) to receive a 48-week treatment with once-daily, subcutaneous injections of either 1.8 mg liraglutide or liraglutide-placebo (control). The primary outcome was improvement in liver histology, defined as ‘resolution of definite NASH’ and no worsening in fibrosis from baseline to end-of-treatment.

Of the 52 randomised patients, 45 underwent end-of-treatment liver biopsies. The primary endpoint was met, and 9 (39%) of 23 patients on liraglutide had resolution of definite NASH with no worsening of fibrosis compared to 2 (9%) of the 22 patients on placebo. Only 2 (9%) patients on liraglutide had worsening of fibrosis compared to 8 (36%) on placebo. Moreover, liraglutide was shown to reduce weight, BMI and fasting glucose compared to placebo. There were no drug-related serious adverse events in patients on liraglutide.

Dr Matthew Armstrong, LEAN co-investigator, NIHR Birmingham Liver Biomedical Research Unit, University of Birmingham, commented: “Although NASH is the most common cause of chronic liver disease, there are still no licensed drugs to treat it. Results from the LEAN trial are a major breakthrough and point towards a potential treatment option for this disease. A Phase 3 trial is now needed to confirm the potential of this class of medication, known as human glucagon-like peptide-1 analogues, as a valid therapeutic option for patients with NASH.”

Professor Philip Newsome, LEAN Chief Investigator, NIHR Birmingham Liver Biomedical Research Unit, University of Birmingham, added: “Clearance of NASH in this study was very encouraging and means we are a step closer to new treatments for patients suffering with non-alcoholic fatty liver disease.”

“NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time, persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels, which can eventually cause cirrhosis. In Europe, the prevalence of NASH is approximately 5% so we welcome the ongoing research and development in this area to help the millions of people affected by this disease,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.

Notes to editors

The study research was supported by the Wellcome Trust and the National Institute for Health Research (NIHR) Birmingham Liver Biomedical Research Unit.

About the National Institute for Health Research
The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

About EASL (www.easl.eu)
Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact
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