Popular Weight Loss Drug Wegovy Shows Encouraging Results in Liver Fibrosis Trial

On Friday, Novo Nordisk A/S NVO released headline results from part 1 of the ongoing ESSENCE Phase 3 trial, a 240-week trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).

Once-weekly, subcutaneous semaglutide 2.4 mg is marketed under the brand name Wegovy.

Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomized people at 72 weeks.

The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis and resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.

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At week 72, 37.0% of people treated with semaglutide 2.4 mg improved liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo. 

62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo.

In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.

Novo Nordisk expects to file for regulatory approvals in the U.S. and EU in the first half of 2025.

The detailed results from ESSENCE will be presented at a scientific conference in 2024.

Part 2 of the ESSENCE trial will continue with the expected readout in 2029.

The update comes as the FDA revised its shortage list to note that the .25 mg starter dose of semaglutide-based obesity med Wegovy is now available in the U.S.

Less than a month ago, the FDA removed Eli Lilly And Co’s LLY tirzepatide from its shortage list.

In October, Novo Nordisk shared data from the SOUL Phase 3 cardiovascular outcomes trial that evaluated subcutaneous once-weekly (injectable) semaglutide 2.4 mg.

The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo.

Major adverse cardiovascular events (MACE) are defined as cardiac arrest, stroke, heart failure, or cardiovascular death.

Price Action: NVO stock is up 0.88% at $112.93 during the premarket session at the last check on Friday.

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