Phase II trial investigates CS060380 + semaglutide for MASH and obesity, targeting liver fat reduction

Metabolic dysfunction-associated steatohepatitis (MASH) is a severe form of fatty liver disease characterized by inflammation and liver damage, often progressing to cirrhosis. It is highly prevalent in individuals with obesity, a major risk factor. Current standard-of-care often involves lifestyle modifications, but pharmacological options are limited. GLP-1 receptor agonists like semaglutide have shown promise, demonstrating significant reductions in liver fat and resolution of MASH without worsening fibrosis in clinical trials. This study explores whether combining semaglutide with the investigational medicine CS060380 can offer enhanced therapeutic benefits for this complex metabolic disorder.

This Phase II, randomized, double-blind, placebo-controlled clinical trial is enrolling approximately 120 adults across 15 sites in China who have both MASH and obesity. The study spans up to 54 weeks, beginning with a 2-week screening period. Participants are then randomized into a 36-week double-blind treatment phase, receiving either CS060380 or placebo, with both groups concurrently receiving semaglutide. This is followed by a 16-week open-label period where all participants receive CS060380. Primary endpoints include changes in liver fat content, measured by a specialized MRI scan, and body weight. Safety and tolerability are assessed via vital signs, blood/urine tests, and adverse event monitoring.

As an ongoing Phase II clinical trial, specific results regarding the efficacy and safety of CS060380 are not yet available. However, the study aims to determine the impact of CS060380 when combined with semaglutide on key metabolic and hepatic parameters. The primary objectives are to quantify the reduction in liver fat content, as measured by MRI-proton density fat fraction (PDFF), and to assess changes in body weight. Secondary objectives include evaluating improvements in liver enzymes (ALT, AST), markers of liver fibrosis, and overall metabolic health. The trial is also designed to thoroughly monitor the safety profile and tolerability of CS060380 in this patient population over the 54-week study duration. The enrollment of approximately 120 participants is expected to provide robust preliminary data on the potential of this combination therapy.

The central aim is to establish whether CS060380 significantly reduces liver fat and body weight in MASH patients with obesity when added to semaglutide.