Wegovy has treated a serious form of liver disease in a major clinical trial

Wegovy weight loss drug has treated a serious form of liver disease in about two thirds of patients in a major clinical trial, according to the results published Wednesday in the New England Journal of Medicine.

Hepatic steatotic disease associated with metabolic dysfunction – previously known as non -alcoholic liver disease – Affects approximately 33% of adults in the United States About 5% to 7% have a more advanced form of the disease, called steatohepatitis or puree associated with metabolic dysfunction. (Another type of liver disease, a liver disease associated with alcohol, is caused by alcohol consumption.)

Both conditions are the result of body storage too much fat in the liver, Dr. Sobia Laique, liver doctor and multidisciplinary Masld Clinic at the Cleveland Clinic said. In people with puree, excess fat has started to cause inflammation, which, over time, can cause scars or fibrosis.

Left untreated, it can progress towards liver insufficiency and liver cancer, said Laique.

According to the steatotic diabetes associated with metabolic dysfunction is more frequent in people with obesity or type 2 diabetes, according to the National Health Institutes. It is estimated that 75% of overweight and more than 90% of people with obesity have the disease.

There is only one drug approved by the FDA for Mash, called Resmetirom, said Laic. However, the medication only contributes about a quarter of patients and does not deal with the underlying conditions that stimulate the disease. Bariatric surgery is often the recommended treatment for those who cannot resolve the condition by lifestyle changes, she added.

“It is quite monumental and will really change paradigm,” said Laique about the results of Wegovy’s test, “because at least in the pharmacotherapy space, you do not yet have a comparable medication.” It was not involved in the clinical trial.

The trial, funded by the NOVO Nordisk drug manufacturer, included 800 patients with puree from 37 countries. The patients obtained a weekly dose of 2.4 milligrams of semaglutide, the active ingredient in the Ozempic and the Wegovy, a placebo, for 72 weeks.

The trial revealed that around 63% of patients in the semaglutide group experienced a reduction in liver inflammation, compared to 34.3% of people who obtained a placebo.

Before starting the test, participants also had moderate levels of scar tissue in the liver, called stadium fibrosis 2 or 3.

About 37% of the semaglutide group experienced improvements in their fibrosis, compared to 22.4% in the placebo group. The semaglutide group has also experienced other advantages, including an average weight loss of 10.5%.

DRE Susan Spratt, endocrinologist and senior medical director of the Duke Health Management Office population in North Carolina who was not involved in the study, said that it was impressed, noting that once fibrosis has developed in patients, it is often difficult to overthrow or treat inflammation.

“This is incredibly news that semaglutide has not only reduced inflammation, but also that fibrosis has regressed,” said Spratt.

Dr. Christopher McGowan, a gastroenterologist who directs a weight loss clinic in Cary, in North Carolina, said in an e-mail that the results can offer hope for a condition with few processing options, but has added that long-term data consist of determining whether the improvements in the drug will reduce complications related to liver and death.

“These results represent a very promising step in the fight against a common, progressive and often silent disease,” said McGowan.

The test results add to the growing list of conditions that GLP -1 – the class of drugs which include the Ozempic of Novo Nordisk and Wegovy and Mounjaro and Zepbound of Eli Lilly – can treat Beyond diabetes and weight loss.

Last year, Food and Drug Administration approved Wegovy To reduce the risk of heart disease in people with obesity. The agency also approved Zepbound for Obstructive sleep apnea in December, and Ozempic at Treat a chronic kidney disease In patients with type 2 diabetes in January. Researchers also examine if the drugs are effective against Alzheimer’s And alcohol dependence.

Insurance companies often hesitate to cover drugs for weight; However, they have shown the desire to cover them when approved for other conditions, such as the risk of heart disease and sleep apnea.

In a statement on Wednesday, Novo Nordisk said that the FDA could make a decision on the advisability of approving Wegovy for Mash at the end of the year.

The FDA has granted the medication a priority revision designation, said the drug manufacturer, which means that it will examine the request in six months, rather than the standard window of nine months.

Spratt noted that side effects can be a barrier for some who want to take Wegovy and similar weight loss drugs.

The drug was well tolerated, according to the test results. The most common adverse events were gastrointestinal, including nausea, diarrhea, constipation and vomiting. The side effects leading to the abandonment of trial people were 2.6% for the semaglutide group and 3.3% for the placebo group.

LAICE wondered if patients would continue to see the improvement after 72 weeks. She also noted that patients should probably continue to take medication or risk returning.

“It is a significant weight loss, but is it also a lasting weight loss?” She said. “And I think this is the part that people often forget the management of obesity, these are two battles.”