Novo Nordisk agonist shows strong trial results as MASH cases rise among US adults
For the first time, a GLP-1 therapy has been cleared to treat metabolic dysfunction-associated steatohepatitis (MASH), after the US Food and Drug Administration (FDA) granted accelerated approval to Novo Nordisk’s weight-loss drug Wegovy.
According to the American Liver Foundation, MASH is a progressive liver condition that affects about 5 percent of US adults.
The New York Times reported that roughly 15 million people, or 6 percent of adults, live with the disease.
MASH develops when fat builds up in the liver, causing inflammation, scarring and cell damage, and it can progress to liver cancer, transplant or death.
The FDA’s decision followed results from the first phase of Novo Nordisk’s ESSENCE trial.
As per the company, 62.9 percent of patients who received Wegovy achieved resolution of steatohepatitis without worsening of fibrosis, compared with 34.3 percent on placebo.
Additionally, 36.8 percent of patients treated with Wegovy experienced improvement in fibrosis with no worsening of steatohepatitis, versus 22.4 percent in the placebo group.
Wegovy is now available in the US for adults with MASH and moderate to advanced liver fibrosis, to be used alongside diet and exercise, Novo Nordisk said.
The drug, administered as a weekly injection, is not intended for patients with cirrhosis.
Jason Brett, principal US medical head at Novo Nordisk, said, “We’re only the second FDA-approved treatment for MASH.” He emphasized the need for better medications with stronger benefit-risk profiles that can also prevent disease progression.
He added that patients need early access to prevent worsening outcomes and that the company is working with payers to enhance access and reimbursement.
Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk, stated, “Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH.”
He noted that this approval complements the proven weight loss, cardiovascular benefits, and broader evidence linked to semaglutide.
The New York Times reported that in one clinical trial, 63 percent of patients taking Wegovy showed clearance of fat and inflammation in the liver without worsening of scarring, compared to 34 percent in the placebo group.
However, patients commonly experienced gastrointestinal side effects such as nausea, vomiting, diarrhoea, constipation and abdominal pain.
Some also reported headaches, dizziness and fatigue. Doctors may need to monitor patients to ensure they do not lose excessive weight.
Currently, Madrigal Pharmaceuticals’ Rezdiffra, approved in 2024, is the only other FDA-cleared treatment for MASH, as reported by Reuters.
Rival Eli Lilly’s tirzepatide, the active ingredient in Mounjaro and Zepbound, showed in a mid-stage trial that up to 74 percent of patients achieved absence of MASH with no worsening of fibrosis.
CNBC reported that shares of Novo Nordisk rose 7.4 percent after the FDA announcement.
The company also said it would lower the cost of Ozempic for cash-paying US patients to $499 per month, less than half its list price.
Novo Nordisk has applied for approval in Europe and Japan this year, with additional results from the second phase of the ESSENCE trial expected in 2029.
The FDA grants accelerated approvals to allow faster access to treatments for serious conditions.
But Reuters noted that the process has faced criticism since some drugs cleared under this pathway have later been proven ineffective.
