Ozempic Shows Promise in Treating a Severe Form of Liver Disease, Study Finds

Ozempic is efficient in treating a extreme type of liver illness that impacts almost 2 million Individuals, based on a research printed in The New England Journal of Drugs in April.

The analysis included 800 individuals with metabolic dysfunction-associated steatohepatitis (MASH), a sophisticated stage of metabolic dysfunction–related steatotic liver illness (MASLD), which begins with fats buildup within the liver.

Not like some liver circumstances, MASH isn’t brought on by alcohol consumption. As an alternative, it’s related to weight problems, sort 2 diabetes, and heart problems.

For the research, the MASH sufferers acquired weekly injections of both a placebo or semaglutide, a glucagon-like peptide-1 receptor agonist and the lively ingredient within the standard medicine Wegovy and Ozempic. The medicines, accredited by the Meals and Drug Administration to deal with weight problems and kind 2 diabetes, are manufactured by the pharmaceutical firm Novo Nordisk, which funded the analysis.

After 72 weeks, two out of three sufferers on semaglutide had important enhancements in fats accumulation and scarring within the liver. Not all individuals with MASH expertise scarring, however as soon as it happens resulting from fats buildup and irritation, the chance of life-threatening circumstances like cirrhosis, liver most cancers, and liver failure rises. MASH is a number one explanation for liver transplants in the US.

The brand new analysis is the primary regulatory research—one designed to assist inform FDA decision-making—to search out that the drug may enhance scarring, stated Philip Newsome, PhD, director of Roger Williams Institute of Liver Research at King’s Faculty London and research co-author.

“If you happen to can cease the scarring, you’ll be able to cease development of the illness,” Newsome instructed Well being.

The research outcomes are half one of many third part of a randomized, double-blind medical trial lasting 240 weeks. 

For the primary 72 weeks, 534 members acquired 2.4 mg of semaglutide weekly, whereas 266 had a placebo. 

Primarily based on liver biopsy reviews, 62.9% of these receiving semaglutide had a discount in steatohepatitis—liver fats and irritation—with out worsening scarring, in comparison with 34% within the placebo group.

Moreover, 33% of these within the semaglutide group noticed their scarring enhance with out worsening steatohepatitis, whereas 22.4% within the placebo group did. These receiving semaglutide additionally had extra enchancment in liver enzyme ranges compared to these taking a placebo.

Notably, in comparison with the placebo group, these taking semaglutide had improved cardiometabolic components thought of drivers of MASH, comparable to blood sugar ranges and insulin resistance. They misplaced a mean of 10.5% of physique weight. 

The research means that semaglutide may lower scarring development that results in advanced-stage liver illness, Manal Abdelmalek, MD, a gastroenterologist and hepatologist at Mayo Clinic, instructed Well being.

However “equally essential,” she added, “the development in insulin resistance, weight reduction, and glycemic management in sufferers with MASH offers a holistic therapeutic method to therapy of each liver illness and related cardiometabolic sicknesses, which additionally impression morbidity and mortality in sufferers with MASH.” 

Researchers don’t absolutely perceive why semaglutide might assist deal with MASH. However the lack of GLP-1 receptors within the liver means that the drug doesn’t work straight on the organ however as a substitute has an oblique impact by decreasing weight and blood sugar ranges, stated Abdelmalek.

That reduces the chance of fats accumulation within the liver, lessening the exercise of “downstream” pathways that drive scarring, she added.

Consistent with earlier analysis, gastrointestinal upset, together with nausea, vomiting, and diarrhea, had been the commonest unintended effects reported by research members. Nonetheless, solely 2.6% of the semaglutide group—and three.3% of the placebo group—discontinued the trial because of the antagonistic impacts.

The research’s limitations included an absence of Black members, in addition to a paucity of knowledge on participant alcohol use and modifications in physique composition. 

Nonetheless, Newsome stated the outcomes construct on “encouraging information” from part two of the trial.

Presently, there are few therapy choices for MASH, a “Twenty first-century epidemic that was largely unrecognized till very not too long ago,” Christos S. Mantzoros, MD, DSc, PhD, chief of endocrinology, diabetes and metabolism on the Boston VA Healthcare System, instructed Well being.

In 2024, the FDA accredited the primary drug—resmetirom—to deal with MASH with reasonable to superior scarring. Docs might prescribe that remedy alongside modifications to way of life components, comparable to eating regimen and train.

Nonetheless, Abdelmalek stated extra therapies are wanted as a result of the long-term advantages of resmetirom stay unknown. Moreover, way of life modifications might be difficult for sufferers—and should not even reverse superior scarring.

Consultants are hopeful that semaglutide will show to be an efficient choice within the MASH therapy toolkit.

“This research would be the first of many research to return which is able to tackle [current] research limitations and lend additional insights concerning semaglutide as a therapy for MASH,” Abdelmalek stated.

With the doable addition of semaglutide and a “sturdy pipeline of rising therapies in part 3 medical trials,” she continued, “the longer term for our sufferers with MASH and MASH-related cirrhosis is vivid.”