Novo Nordisk posts Phase 3 win for obesity drug in MASH

Novo Nordisk (NVO) announced Friday a pivotal Phase 3 trial designed to test its weight loss therapy semaglutide on patients with a liver disease called metabolic dysfunction-associated steatohepatitis (MASH) achieved its primary endpoints.

While the Danish drugmaker advanced ~1% in reaction to the result, its rival Eli Lilly (LLY), which markets a similar gut-hormone-based weight loss drug called tirzepatide for obesity, traded flat. Madrigal Pharmaceuticals (MDGL), the maker of recently approved MASH therapy Rezdiffra, fell ~4%.

Citing data from the 72-week Part 1 of its ESSENCE trial, Novo (NVO) said the semaglutide 2.4 mg dose it evaluated indicated a safe and well-tolerated profile. The two-part trial included MASH patients and those with liver fibrosis.

ESSENCE achieved the main goals as patients on semaglutide demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of liver fibrosis or steatohepatitis, an advanced form of non-alcoholic fatty liver disease.

The company said it would file for U.S. and EU regulatory approvals for the drug in H1 2025. 240-week Part 2 of the ESSENCE trial is ongoing; its data are expected in 2029.