In a phase 2 trial, survodutide met it’s primary goals for liver fat content, transaminases, and fibrosis markers.
Survodutide met its primary endpoints in a phase 2 trial for participants with metabolic dysfunction-associated steatohepatitis (MASH). The agent reduced liver fat content (LFC), transaminases, and fibrosis markers while being generally well tolerated.
The multinational, double-blind, phase 2 trial (NCT04771273) involved 295 adults with biopsy-proven MASH, liver fibrosis (stage F1-F3), and a BMI of under or equal to 35 kg/m². Participants were randomly assigned to receive a placebo or survodutide at doses of 2.4, 4.8, or 6.0 mg (escalated from 0.3 mg) over 48 weeks. Dr Naim Alkhouri, MD, from Arizona Liver Health, presented the interim analysis results at week 28.
By week 28, 90.9% of participants receiving 2.4 mg, 88.9% receiving 4.8 mg, and 87% receiving 6.0 mg of survodutide achieved a 30% under or equal to reduction in LFC, compared to 25% with placebo (P<0.001 for all comparisons). The mean relative changes in LFC with survodutide were -55.4%, -65.3%, and -62% for the respective doses, compared to -13.1% with placebo. Mean absolute reductions in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were -37.8 U/L and -30.8 U/L with survodutide, versus -10.4 U/L and -5.1 U/L with placebo. Pro-peptide of type III collagen (Pro-C3) levels decreased by up to -25.6% with survodutide, compared to an increase of 1.6% with placebo. Enhanced liver fibrosis (ELF) scores showed a mean absolute decrease of up to -0.8 with survodutide, compared to -0.0 with placebo. Additionally, body weight decreased by up to 12.5% with survodutide, compared to 2.6% with placebo, and hemoglobin A1C decreased by up to 0.8%, compared to 0% with placebo.
AEs were reported in 92.3% of participants receiving survodutide and 88.2% of those receiving placebo, with gastrointestinal issues being the most common. Gastrointestinal AEs led to discontinuation in 18.3% of participants receiving survodutide, compared with 2.9% receiving placebo. No unexpected safety issues were reported.
“Survodutide significantly reduces LFC, ALT and AST levels, body weight, and A1C. It also decreases fibrosis biomarkers Pro-C3 and ELF. Discontinuation due to gastrointestinal AEs was dose-dependent, with no unexpected safety trends observed,” concluded Dr Alkhouri.
Medical writing support was provided by Federica Angius.
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