The blockbuster Novo Nordisk weight problems drug Wegovy has met the principle objectives of a pivotal check in metabolic dysfunction steatohepatitis, or MASH, outcomes the drugmaker says help increasing the product’s label to incorporate this prevalent fatty liver illness.
MASH is a metabolic dysfunction wherein the buildup of liver fats results in worsening operate of the organ. In superior circumstances, sufferers require a liver transplant. Greater than 250 million individuals worldwide are estimated to have MASH. Wegovy’s foremost ingredient is semaglutide, an engineered peptide that binds to the GLP-1 receptor to spark metabolic results. Semaglutide was initially authorised for treating sort 2 diabetes, the place the drug is marketed as Ozempic.
The preliminary outcomes reported Friday are from a placebo-controlled Part 3 medical trial enrolling 1,200 members who’ve MASH with moderate-to-advanced liver scarring, often known as fibrosis. After 72 weeks, Novo Nordisk stated 37% of people that obtained once-weekly injections of Wegovy on prime of ordinary of care confirmed enchancment in liver fibrosis with no worsening of the fatty liver illness. For many who obtained a placebo and commonplace care, 22.5% achieved this objective.
Novo Nordisk additionally stated 62.9% of sufferers within the Wegovy group achieved decision of the fatty liver illness with no worsening of liver fibrosis. By comparability, 34.1% of these within the placebo group achieved this objective. The corporate stated the outcomes have been sufficient to be statistically vital. On measures of security and tolerability, Novo Nordisk stated Wegovy was similar to earlier assessments of the drug. The corporate stated extra element will probably be introduced at a medical convention later this yr.
The newest outcomes are from Half 1 of a two-part examine Part 3 examine. The second half is evaluating how nicely Wegovy lowers the danger of liver-related medical occasions in comparison with a placebo at 240 weeks. Novo Nordisk expects Half 2 of the examine will publish knowledge in 2029. However based mostly on the medical knowledge thus far, the corporate expects to file purposes looking for U.S. and European Union approval in MASH within the first half of subsequent yr.
In a notice despatched to traders Friday, Leerink Companions analyst Thomas Smith wrote that the information readout is essentially according to the agency’s best-case situation — statistically vital enchancment in fibrosis, however not a game-changing consequence. Leerink believes this class of peptide medicine have utility addressing some points of MASH together with the illness’s comorbidities, resembling weight problems, sort 2 diabetes, and heart problems. Nevertheless, Smith stated the information affirm Leerink’s thesis that these medicine “don’t signify a ‘silver bullet or useful treatment for [MASH] sufferers with superior fibrosis, and over the long run, we anticipate polypharmacy and mixture use will grow to be commonplace of care.”
Within the view of William Blair analyst Andy Hsieh, the magnitude of fibrosis enchancment is just like that achieved by Rezdiffra, the Madrigal Prescribed drugs drug that turned the primary FDA-approved MASH therapy earlier this yr. The placebo-adjusted enchancment in fibrosis with no worsening of illness for Rezdiffra, a once-daily tablet, was 12% in comparison with 14% for once-weekly injectable Wegovy.
Earlier this yr, Eli Lilly and Boehringer Ingelheim every posted encouraging medical trial outcomes for his or her potential MASH therapies. Hsieh stated the consensus view inside the funding neighborhood is that the GLP-1 receptor agonist class will seemingly be integrated into the therapy paradigm for MASH.
“It’s our view that immediately’s improvement provides to the rising physique of proof in help of that development,” Hsieh stated.
Photograph: Michael Siluk/UCG/Common Photos Group, through Getty Photos
