The U.S. Food and Drug Administration (FDA) has approved the injected weight loss drug Wegovy for a new use: treating adults with an advanced form of metabolic dysfunction–associated steatotic liver disease (MASLD).
“This is a very exciting development for people who are experiencing MASH,” says Ani Kardashian, MD, an assistant professor and hepatologist with Keck Medicine at the University of Southern California in Los Angeles.
“Prior to Wegovy, there was only one other FDA-approved medication for MASH — Rezdiffra — so treatment options have been quite limited,” Dr. Kardashian says. “The mainstay of treatment for MASH has been dietary and lifestyle modification to achieve adequate weight loss to reverse fat buildup and inflammation in the liver.”
What Is Metabolic-Associated Steatohepatitis (MASH)?
MASLD develops when a buildup of fat in the liver causes inflammation and tissue damage. Over time, this can lead to scarring (fibrosis) or severe liver disease (cirrhosis) that may require a transplant. MASLD, previously called nonalcoholic fatty liver disease, is not due to excessive alcohol consumption and typically develops in people who are overweight or have obesity.
MASH is a severe form of MASLD that develops when fat buildup in the liver causes inflammation and scarring. Conditions such as obesity, type 2 diabetes, and high cholesterol can all increase the odds of developing MASH.
How Does Wegovy Treat MASH?
Wegovy, which contains the active ingredient semaglutide, treats MASH by aiding weight loss, says Scott Isaacs, MD, an adjunct associate professor at Emory University School of Medicine in Atlanta and president of the American Association of Clinical Endocrinology.
“Semaglutide acts on the brain’s appetite regulation center to decrease appetite, reduce cravings, and diminish ‘food noise,’ leading to significant, sustained weight loss,” Dr. Isaacs says. “This weight loss, in turn, improves insulin sensitivity, decreases liver fat, and can reverse the inflammation and cellular injury in MASH.”
In an ongoing clinical trial of 800 people with MASH randomly assigned to take either Wegovy or a placebo, liver biopsies done at 72 weeks found the medication effective for improving liver health, according to the FDA.
Overall, 63 percent of participants on Wegovy had MASH resolve or no worsening of liver scarring, compared with 34 percent of people on placebo, per the FDA. In addition, 37 percent of participants on Wegovy saw improvement in liver scarring and no worsening of MASH, compared with 22 percent with the placebo.
This trial will continue up to 240 weeks to determine whether inflammation and scarring improvements seen after 72 weeks translate into fewer deaths, liver transplants, or other liver-related health issues, the FDA said.
What Are the Side Effects of Wegovy for MASH?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Headache
- Fatigue
- Dizziness
- Stomach flu
- Common colds
New MASH Indication Could Expand Wegovy Access
FDA approval of Wegovy for MASH should make it easier for some patients who need this medication to get it, says Amreen Dinani, MD, a gastroenterologist and associate professor at Duke University School of Medicine in Durham, North Carolina.
“Having another indication for Wegovy will hopefully help more patients that are eligible for Wegovy to get access to prescription and insurance coverage,” Dr. Dinani says.
Exactly how many more people access Wegovy is hard to say, however, because many people with MASH may also have obesity or type 2 diabetes and already take semaglutide for these conditions, Isaacs says.
“The incremental change may be in patients who have MASH with advanced liver fibrosis but who do not have diabetes and previously could not qualify for obesity medication coverage,” Isaacs says. “For these individuals, the MASH indication might improve access.”
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