At the 76th annual AASLD Liver Meeting®, Novo Nordisk presented new findings from a post hoc analysis of the ESSENCE phase 3 trial, highlighting the impact of semaglutide 2.4 mg (Wegovy®) on liver health in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced fibrosis, as reported by Drugs.com.
Key Findings:
- Independent of Weight Loss: Improvements in liver injury markers and histology were observed even in patients with minimal weight reduction (≤2%).
- Histological Outcomes: 48.4% of patients on semaglutide achieved resolution of steatohepatitis versus 25.8% on placebo in the lowest weight-loss subgroup.
- Fibrosis Trends: Semaglutide showed favorable trends for reducing liver scarring across weight-loss categories.
- Biomarker Response: Non-invasive tests, particularly ALT levels, improved significantly in semaglutide-treated patients compared to placebo.
Broader Implications:
MASH affects over 250 million people globally and is often linked to obesity, type 2 diabetes, and cardiovascular disease. The disease is largely asymptomatic in early stages, yet can progress to cirrhosis, liver failure, and increased mortality. Current data suggest semaglutide may offer therapeutic benefits beyond weight management, addressing liver health directly.
ESSENCE Trial Overview:
- Design: Two-part, phase 3 study with 1,197 participants randomized to semaglutide or placebo for up to 240 weeks.
- Part 1: Focused on histological improvement at 72 weeks.
- Part 2: Ongoing, assessing long-term outcomes including liver-related clinical events (readout expected in 2029).
Safety Note:
Semaglutide carries a boxed warning for potential thyroid tumors and is contraindicated in individuals with a history of medullary thyroid carcinoma or MEN 2. Common side effects include gastrointestinal symptoms and fatigue.
