Novo Nordisk Presents New Subgroup Analyses from ESSENCE Trial Demonstrating Semaglutide 2.4 mg Efficacy in MASH Treatment

Recently, Novo NordiskNovo Nordisk in2025 European Association for the Study of the Liver（EASL）At the conference, ongoingA Follow-up Analysis of the First Phase Results of the ESSENCE Trial.

Source: Novo Nordisk Official WeChat

ESSENCE Trial in Metabolic Dysfunction-Associated LipidFatty Hepatitis（MASH）Evaluation of Semaglutide in PatientsEfficacy of 2.4 mg Semaglutide Once Weekly。The ESSENCE trial is divided into two phases, planning to enroll 1,200 participants in total. On top of standard treatment, participants will be randomly assigned in a 2:1 ratio to receive either semaglutide 2.4 mg or a placebo for 240 weeks.

Analysis shows that: at Week 72, based on histological and non-invasive testing (NIT) criteria, compared with placebo,A higher proportion of subjects treated with semaglutide 2.4 mg achieved a therapeutic response.。

At Week 72, histology obtained via liver biopsy and four non-invasive tests(Two of which are used to assess disease activity), and the other two are used to assess the degree of liver fibrosis.）, evaluated the treatment response related to disease activity and degree of liver fibrosis in patients.。

In terms of disease activity, 90.3% of patients in the semaglutide 2.4 mg treatment group met at least one response criterion, compared to 59.2% in the placebo group. Additionally, 45.7% of patients in the semaglutide 2.4 mg treatment group met all response criteria.(ALT, FAST, and Histology), the proportion in the placebo group was 10.4%. Among patients receiving semaglutide 2.4 mg treatment, there was significant overlap in treatment response: 75.1% of patients met any two response criteria simultaneously, compared to 30.4% in the placebo group.。

Similar results were observed in fibrosis-related criteria: 84.3% of patients in the semaglutide 2.4 mg group met at least one treatment response criterion, compared to 55% in the placebo group. Overall, 16.0% of patients in the semaglutide 2.4 mg treatment group met all response criteria (ELF, LSM-VCTE, and histology), compared to 5.6% in the placebo group.Compared with the placebo group, the treatment response overlap was higher in the semaglutide 2.4 mg treatment group, with 53.9% of patients meeting any two criteria, compared to 19.2% in the placebo group.。

ESSENCE III Phase Trial Is Underway; Phase 2 Results Verifying Long-Term Clinical Outcomes to Be Published in 2029。

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