DENMARK—Danish pharmaceutical giant, Novo Nordisk, has shared promising results from the first part of its ongoing Phase 3 ESSENCE trial.
This study evaluated the effects of once-weekly subcutaneous semaglutide 2.4 mg on liver health, specifically in people with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).
The findings were presented at the 75th American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting.
The primary objective of the trial was to assess how semaglutide 2.4 mg affected liver tissue compared to a placebo.
At Week 72, the results were striking: 62.9% of individuals treated with semaglutide achieved resolution of steatohepatitis without worsening liver fibrosis, compared to just 34.1% in the placebo group.
Additionally, 37.0% of those treated with semaglutide saw improvements in liver fibrosis without worsening steatohepatitis, while only 22.5% of those on placebo experienced similar benefits.
In terms of secondary endpoints, the trial showed that 32.8% of participants receiving semaglutide experienced both resolution of steatohepatitis and improvements in liver fibrosis.
This was a significant improvement compared to 16.2% of placebo-treated participants who showed similar results.
These findings suggest that semaglutide 2.4 mg may play an important role in managing MASH, a condition affecting approximately one in 20 adults in the United States.
Arun Sanyal, MD, the principal investigator of the study, commented on these encouraging results, noting that the data presented at The Liver Meeting® demonstrate semaglutide’s ability to slow the progression of MASH and even reverse existing liver damage.
He emphasized that the ESSENCE trial results could be a game-changer for patients with MASH, offering a potential new treatment option.
Further supporting the positive outcomes, secondary analyses also showed improvements in non-invasive liver function tests (NITs) among those treated with semaglutide.
This included better liver enzyme levels, such as ALT, AST, and GGT, as well as improvements in the Enhanced Liver Fibrosis (ELF)™ test.
In terms of safety, semaglutide 2.4 mg demonstrated a profile similar to that observed in other therapeutic areas, with no unexpected adverse effects.
Anna Windle, PhD, senior vice president of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk, expressed her satisfaction with the trial’s findings.
She highlighted that the data presented at AASLD strengthen the growing body of evidence supporting semaglutide 2.4 mg for individuals living with chronic conditions like MASH.
Windle also noted that the data will help further the understanding of how MASH is connected to other cardiometabolic conditions such as type 2 diabetes, obesity, dyslipidemia, and high blood pressure.
Currently, semaglutide 2.4 mg is not approved for the treatment of MASH in the US, but Novo Nordisk plans to submit regulatory filings for approval in the first half of 2025.
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