Ask VialBase
Research

A Research Study to See How Well Semaglutide Works in People With Non-alcoholic Steatohepatitis (ESSENCE) — VialBase Research

Trial Summary

ESSENCE is a pivotal Phase 3 trial evaluating semaglutide 2.4 mg (the obesity dose) for treatment of NASH with liver fibrosis. This is one of the most closely watched liver trials in the GLP-1 space, as Phase 2 data showed significant histological improvement in NASH resolution.

Design

  • Type: Randomized, double-blind, placebo-controlled, multicenter
  • Population: Adults with biopsy-confirmed NASH and fibrosis stage F2-F3
  • Arms: Semaglutide 2.4 mg SC weekly vs. placebo
  • Duration: 72 weeks of treatment with liver biopsy endpoints
  • Co-primary endpoints: (1) NASH resolution with no worsening fibrosis, (2) Fibrosis improvement by at least one stage with no worsening NASH

Key Outcomes

Interim results (reported 2024) showed semaglutide met both co-primary endpoints with statistically significant improvements in NASH resolution and fibrosis improvement vs. placebo. Full dataset and long-term outcomes pending.

Significance for Peptide Research

NASH/MASH is a massive unmet need with no well-established pharmacotherapy. Semaglutide’s dual metabolic and anti-inflammatory effects make it uniquely suited. Positive results here could make semaglutide the first GLP-1 RA approved for liver disease, further establishing the peptide class as multi-organ therapeutics. The ESSENCE data directly informs the metabolic liver disease treatment landscape.

See Also