IBI362 vs. Semaglutide for Fatty Liver Disease in Overweight Chinese Adults

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), formerly known as NAFLD, is a growing global health concern, particularly prevalent in individuals who are overweight or obese. It can progress to more severe liver conditions like cirrhosis and liver cancer. While GLP-1 receptor agonists like semaglutide have shown promise in managing weight and improving metabolic parameters, their direct efficacy and comparative safety against novel agents like IBI362 specifically for MAFLD in a Chinese population remain to be fully established. This Phase III study aims to directly compare the efficacy and safety of IBI362 against semaglutide in Chinese adults with MAFLD.

As this is a recruiting Phase III study (NCT06884293), specific efficacy and safety results are not yet available. However, the study aims to demonstrate that IBI362 is at least as effective as, if not superior to, semaglutide in reducing liver fat content and improving other metabolic markers in patients with MAFLD. Key primary endpoints will likely include the proportion of participants achieving a significant reduction in liver fat (e.g., >30% relative reduction or >5% absolute reduction) as measured by imaging techniques. Secondary endpoints will assess changes in body weight, liver enzymes, glycemic control, and overall safety profiles, with a focus on adverse events. The primary objective is to compare the efficacy and safety of IBI362 versus semaglutide in improving MAFLD in overweight or obese Chinese adults over 48 weeks.