Novo's trial of weight-loss drug shows improvement in fatty liver disease
The study used 2.4 milligram dose of semaglutide to treat a liver condition called metabolic dysfunction-associated steatohepatitis, or MASH, in one part of the trial involving 800 patients
Novo Nordisk said on Friday its weight-loss drug met the main goal of a late-stage trial in patients with a type of fatty liver disease by reducing scarring of the organ without worsening the condition.
The study used 2.4 milligram dose of semaglutide to treat a liver condition called metabolic dysfunction-associated steatohepatitis, or MASH, in one part of the trial involving 800 patients.
Semaglutide is sold as Wegovy for weight-loss and Ozempic for diabetes.
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At 72 weeks, 37% of patients on the drug showed improvement in liver scarring, with no worsening of steatohepatitis, an inflammation of the organ due to excess fat deposits, compared with 22.5% of those on placebo.
In the trial, 62.9% of those on the drug also achieved resolution of steatohepatitis compared with 34.1% on placebo.
MASH, which was earlier known as NASH or non-alcoholic steatohepatitis, affects around 5% of adults in the US, according to the American Liver Foundation, making it a large patient population.
But Madrigal Pharmaceuticals' Rezdiffra is the only approved treatment.
"The long-term perspective paints a positive picture as large pharma has resources to substantially grow this market to create an even larger opportunity for Rezdiffra," said Piper Sandler analyst Yasmeen Rahimi.
Shares of Novo Nordisk rose 1% in Copenhagen, while Madrigal added 22% in New York. Drug developer Akero Therapeutics rose 5%.
Novo's drug showed a 14.5% difference between improvement in fibrosis after adjusting for the placebo, compared to 12% shown by 100 mg dose of Rezdiffra in a separate late-stage trial.
Lilly's tirzepatide - the active ingredient popular diabetes drug Mounjaro and weight-loss drug Zepbound - helped up to 74% of patients achieve absence of the disease with no worsening of scarring in a mid-stage trial.
Jefferies analyst Peter Welford expects Wegovy to generate $2 billion at the peak of its sales outside of obesity from MASH patients.
Novo Nordisk expects to file for regulatory approvals in the US and the European Union in the first half of 2025.
Novo and Lilly are also testing their weight-loss drug for several other conditions, including Alzheimer's disease.
