63% of patients with steatohepatitis have regressed! Semaglutide demonstrates therapeutic potential for MASH

63% of patients with steatohepatitis have regressed! Semaglutide demonstrates therapeutic potential for MASH

On November 1st, Novo Nordisk announced the main results of the ongoing ESSENSE trial Part 1, a critical phase 3 double-blind 240 week trial involving 1200 adults with metabolic dysfunction associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (phase 2 or 3).

Compared with placebo, this trial achieved its primary endpoint by demonstrating a statistically significant and superior improvement in liver fibrosis, without worsening of steatohepatitis, and with regression of steatohepatitis and no worsening of liver fibrosis. In week 72, 37.0% of patients treated with 2.4 mg semaglutide showed improvement in liver fibrosis and no worsening of steatohepatitis, compared to 22.5% of patients treated with placebo. Among patients receiving 2.4 mg semaglutide treatment, 62.9% of them experienced relief of steatohepatitis without worsening of liver fibrosis, while among patients receiving placebo treatment, this proportion was 34.1%

In the experiment, 2.4 mg semaglutide had the same safety and tolerability as the previous 2.4 mg semaglutide trial.

We are very pleased with the results of the ESSENSE clinical trial and the potential of semaglutide to assist MASH patients, "said Martin, Executive Vice President and Head of Development at Novo Nordisk

Holst Lange stated. One third of overweight or obese individuals suffer from MASH. This has a serious impact on their health and represents a significant unmet need

Novo Nordisk is expected to apply for regulatory approval in the United States and the European Union in the first half of 2025. The detailed results of ESSENSE will be announced at the 2024 scientific conference. The second part of the ESSENSE test will continue and the results are expected to be announced in 2029.

Regarding MASH

Metabolic dysfunction associated steatohepatitis (MASH) is a serious, progressive metabolic disease that affects the liver and can be fatal if not managed properly. More than 250 million people suffer from MASH, and it is expected that the number of people in advanced stages of the disease will double by 2030. More than one-third of overweight or obese individuals currently suffer from MASH. People with MASH often have few or no specific symptoms in the early stages of the disease, which often leads to delayed diagnosis. People with MASH have a higher risk of developing advanced liver disease (including liver cancer) than the general population.

Regarding the ESSENSE test

ESSENSE is a phase 3 trial aimed at evaluating the effect of weekly subcutaneous injection of 2.4 mg semaglutide on adult patients with metabolic dysfunction associated steatohepatitis accompanied by moderate to advanced liver fibrosis (phase 2 or 3). ESSENSE is a two-part trial in which 1200 planned participants are randomly assigned in a 2:1 ratio to receive 2.4 mg of semaglutide or placebo treatment, while also receiving 240 weeks of standard treatment. In Part 1, the goal is to demonstrate that 2.4 mg semaglutide treatment can improve liver histology at 72 weeks based on biopsy samples from the first 800 randomized patients. In Part 2, the objective is to demonstrate that treatment with 2.4 mg semaglutide can reduce the risk of liver related clinical events in adults with MASH and moderate to advanced liver fibrosis at 240 weeks compared to placebo.