Resumen

Objectives: • Primary Objectives Assess the proportion of subjects who lose at least 150 mL of subcutaneous fat volume as measured by ultrasound compared with placebo • Secondary Objectives 1. Assess the proportion of subjects who lose at least 200 mL of subcutaneous fat volume as measured by ultrasound compared with placebo 2. Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over the treated area as measured by ultrasound compared with placebo Introduction: The current fat reduction procedures include invasive surgery and non-invasive products. A study has shown that liposuction can remove 183.3mL of abdomen fat on average, yet it may carry the risk of unfavorable outcomes. The efficacy of non-invasive procedures is generally less optimal efficacy with potential side effects. CBL-514 is a lipolysis injection that can induce adipocyte apoptosis to reduce subcutaneous fat in non-clinical studies. A Phase 2a study showed that CBL-514 significantly reduced 24.96%(p< 0.00001) of fat volume and 7.39mm(p<0.0001) of fat thickness compared with baseline. Materials / method: CBL-514 was administered via injection into the subcutaneous adipose layer on the abdomen. A total of 76 subjects were randomized in a ratio of 2:1 to receive CBL-514 or placebo. Each subject received up to 4 treatments and up to 600 mg per treatment allocated CBL-514 or placebo administered subcutaneously to the abdomen with a treatment interval of once every 4 weeks, followed by two follow-up visits scheduled at 4 weeks and 8 weeks post the last treatment. Results: 85.7% and 76.2% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after receiving CBL-514 treatment(s). Compared with placebo, a mean of 312.1mL of subcutaneous fat reduction was observed in CBL-514 group at the 4-week follow-up visit. 42.9% of participants lost at least 150 mL of subcutaneous fat in the treated area after one CBL-514 treatment. Overall, the study demonstrated clinically and statistically significant efficacy of CBL-514 in reducing subcutaneous fat in the treated areas, with favorable safety and tolerability profiles. Conclusion: The efficacy that CBL-514 performs is similar to or better than liposuction and is superior to existing non-invasive procedures for fat reduction. CBL-514 could be a new, promising, non-invasive treatment for fat reduction.