The Zhitong Finance App learned that Novo Nordisk (NVO.US) said on Sunday that its weight loss drug Wegovy was associated with improvements in several liver health indicators. The subjects were patients with a severe liver disease and a body mass index (BMI) below 27. For investors, this result means that Wegovy may cover liver disease treatment for non-obese patients, thereby expanding its commercial footprint beyond weight management. The drug has previously received accelerated FDA approval for specific MASH patients, but continued approval may depend on whether its clinical benefits are confirmed.
This result comes from an additional analysis of the company's Phase 3 ESSENCE trial involving 106 patients with metabolic dysfunction-related steatohepatitis (MASH) — a condition characterized by fat accumulation, inflammation, and scarring in the liver.
After 72 weeks of treatment, patients receiving weekly injections of simeglutide (the active ingredient in Wegovy) showed a greater improvement in the liver enzymes ALT and AST than in the placebo group — elevated levels of these two enzymes may indicate liver damage. The researchers also reported improvements in ELF and PRO-C3, two blood indicators associated with liver scarring (i.e. liver fibrosis). Another liver hardness measurement showed favorable numerical trends, but the results were not statistically definitive.
These results were presented at the American Association for the Study of Liver Disease (AASLD) annual meeting in Denver. Novo Nordisk cautions that this retrospective analysis is an exploratory study and requires further verification.
The ongoing ESSENCE trial, involving 1,197 patients, is expected to evaluate whether simeglutide can reduce serious liver-related complications within 240 weeks. Wegovy's instructions include a black-framed warning about the potential to cause thyroid tumors (including cancer).