The results released from the Phase III ESSENCE clinical trial, and recently published by Medical Xpress and in the NEJM, found that the drug semaglutide is effective in the treatment of fatty liver disease. Semaglutide is classified as a receptor agonist, a drug that binds to a specific receptor and activates a biological response. It is used in the treatment of type-2 diabetes. At higher doses, it is effective for adult weight management.
NAFLD vs. MASLD
NAFLD or Non-alcoholic fatty liver disease was officially renamed to Metabolic dysfunction-associated steatotic liver disease (MASLD) in 2023. The change was made in accordance with a shift in the understanding that NAFLD reflects metabolic dysfunction and does not strictly reflect a non-alcoholic condition.
MASLD is a chronic, long-lasting liver condition resulting from too much fat in a person’s liver.
Please note: Semaglutide is given by prescription and should only be used under the guidance of a healthcare professional.
About MASH
Participants in the Phase III placebo-controlled trial, conducted across 253 sites worldwide, had a form of liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH, renamed from NASH (non-alcoholic steatohepatitis), is a severe form of liver disease. It is linked to obesity and other conditions including type-2 diabetes and heart/circulatory diseases.
Co-leaders for this first regulatory trial are Chief Investigator Philip Newsome of King’s College in the UK, and Professor Arum Sanyal at VCU’s School of Medicine in the United States.
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
The disease is a condition where there is a buildup of fat in the liver in people with diabetes, obesity, high blood pressure, or high cholesterol, and drink little to no alcohol. Up to 30 out of 100 people, or over 100 million of American adults, have MASLD. It should be noted that in time, fat builds up in the liver and may lead to inflammation, cirrhosis, and liver fibrosis as well as liver cancer. Although MASLD impacts one person in every five individuals in the UK, currently there are no medications under license to treat the disorder.
The ESSENCE Trial: 800 Participants Randomly Assigned
Eight hundred people participated in the ESSENCE trial between May of 2021 and April 2023. Those participating were randomly chosen to receive a one-time weekly injection of semaglutide or 2.4 milligrams of placebo as well as counselling. Over half of those participating had type-2 diabetes and about three-quarters were obese.
Results of the ESSENCE Trial
ESSENCE trial results were announced at the 72-week mark. A reduction in inflammation and fat accumulation in the liver was attained for 62.9% of participants as opposed to 34.3% of participants assigned to a placebo. A secondary result showed that 36.8% of the group who received semaglutide had an improvement in their liver fibrosis, as well as 10.5% weight loss. The placebo group experienced 22.4% improvement in the liver fibrosis. Adverse events such as diarrhea, nausea and constipation were more commonly found in the semaglutide group as opposed to the placebo cohort.
Data to determine long-term results has been scheduled, including approximately 1,200 participants from 37 countries over five years. The end goal is to determine semaglutide’s effect on long-term liver complications.
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