Novo Nordisk’s ESSENCE trial shows promising results for semaglutide 2.4 mg in treating MASH

DENMARK – Novo Nordisk has revealed encouraging preliminary results from part one of its ongoing ESSENCE trial, a critical phase 3, double-blinded study spanning 240 weeks.

The trial, which involves 1,200 adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stages 2 or 3), is evaluating the effects of the medication semaglutide at a dose of 2.4 mg.

In part one of the study, 800 participants were given weekly doses of semaglutide or a placebo along with standard care for a 72-week period.

Novo Nordisk reported that the trial met its primary goals, showing a marked improvement in liver fibrosis and a resolution of steatohepatitis without worsening either condition in participants who received semaglutide compared to those on the placebo.

This positive outcome closely follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), issuing a favourable opinion on updating the label of Wegovy® (semaglutide 2.4 mg) for use in the European Union.

 The new label modification recommendation recognizes the potential of semaglutide in treating obesity-related health issues, which aligns with the observed benefits in liver health among those with MASH.

The data from the ESSENCE trial revealed that at the 72-week mark, 37% of participants on semaglutide 2.4 mg showed improvement in liver fibrosis without a worsening of steatohepatitis, while only 22.5% of those on placebo experienced similar benefits.

Furthermore, 62.9% of those on semaglutide resolved steatohepatitis without worsening liver fibrosis, compared to 34.1% in the placebo group.

These results suggest that semaglutide 2.4 mg may be a promising option for those living with MASH, a condition that is particularly prevalent among individuals with obesity. 

Throughout the trial, semaglutide 2.4 mg maintained a safety profile consistent with prior studies, being both safe and well-tolerated by participants.

Martin Holst Lange, Novo Nordisk’s executive vice president and head of Development, expressed optimism about semaglutide’s potential to address the significant unmet needs in managing MASH, noting that one in three individuals with overweight or obesity also suffers from this condition, which can severely impact health.

With these promising results, Novo Nordisk plans to seek regulatory approval in the United States and European Union in the first half of 2025.

Detailed findings from part one of the ESSENCE trial will be presented at an upcoming scientific conference in 2024, while part two of the study is ongoing, with final results anticipated in 2029.

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