Resumo

Objectives: To evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat compared to placebo by using Abdominal Fat Rating Scale (AFRS) and MRI to assess the efficacy. Introduction: CBL-514 is a lipolysis injection that can induce adipocyte apoptosis to reduce subcutaneous fat. The latest Phase 2b study showed that compared with the placebo group, the LS mean difference of the subcutaneous fat volume change eight weeks after CBL-514 treatments were -28.1 % (p< 0.001) and -276.8mL (p< 0.0001). The efficacy of CBL-514 for fat reduction is comparable to or exceeds that of liposuction, with a favorable safety profile. Materials / method: A total of 107 participants with moderate to severe abdominal subcutaneous fat accumulation as assessed by the investigator via live evaluation using the CR-AFRS were enrolled and randomized in a 1:1 ratio to receive up to 4 treatments of allocated CBL-514 or placebo administered subcutaneously to the abdomen, once every 3 weeks, along with 3 follow-up visits at 4, 8, and 12 weeks post the last treatment Results: All efficacy endpoints achieved. The results demonstrated that 81.8% of CBL-514-treated participants compared with placebo (16.7% and 18.5%)achieved at least 1-grade improvement. 58.8% of the participants only required one CBL-514 treatment to achieve at least 1-grade CR-AFRS improvement. Compared to the placebo group, CBL-514 reduced an average of over 31 % of abdominal subcutaneous fat thickness in PP population. Overall, the safety and tolerability profiles of CBL-514 were favorable and consistent with previous CBL-514 clinical studies. Conclusion: CBL-514, the first-in-class new injectable drug for large-area fat reduction, appears to provide significant benefits for subcutaneous fat accumulation, suggesting it may be a promising, novel, better non-surgical fat reduction option warranting further Phase 3 investigation in a larger population.