The Phase 3 clinical trial (NCT06184568) investigating mazdutide (also known as ibi362) for Chinese adults with early Type 2 Diabetes and Obesity reached its primary completion on 2025-09-17. This study compared mazdutide to semaglutide, a known treatment for these conditions.

Background

Mazdutide (ibi362) is being investigated as a potential treatment for Type 2 Diabetes and Obesity. This particular trial aims to evaluate its efficacy and safety profile in comparison to semaglutide, an established therapeutic option for individuals with these conditions.

Trial design

The study (NCT06184568) is a multicenter, randomized, open-label Phase 3 clinical trial. It enrolled 349 Chinese adults diagnosed with obesity (defined as BMI ≥ 28kg/m2) and early Type 2 Diabetes. The trial's design involved an active-controlled treatment period of 32 weeks, during which subjects were randomly assigned to receive either ibi362 6 mg once weekly or semaglutide 1 mg once weekly. Both study treatments are administered subcutaneously. Following this initial period, participants originally on mazdutide entered an extension phase for an additional 24 weeks, where they continued with mazdutide 9 mg or 6 mg based on whether they achieved a predefined weight-loss target.

What this means

The primary completion of this Phase 3 trial signifies that the main data collection phase for the study has concluded. This milestone is crucial as it allows researchers to proceed with the comprehensive analysis of the collected efficacy and safety data for mazdutide. The comparison against semaglutide, a known treatment for Type 2 Diabetes and Obesity, is particularly important for understanding mazdutide's potential competitive profile. The anticipated results will provide valuable insights for clinicians and patients regarding mazdutide's role as a potential new therapeutic option for managing Type 2 Diabetes and Obesity in the Chinese adult population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT06184568, titled "A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity," was recorded as primary completion on 2025-09-17 on clinicaltrials.gov.