Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction

Abstract

Background CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction. Objectives To assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness. Methods This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4- and 8-weeks following the last treatment. Participants were randomly allocated to 1.2 mg/cm 2 (180 mg), 1.6 mg/cm 2 (240 mg), or 2.0 mg/cm 2 (300 mg) of CBL-514 with up to 4 treatments, each with 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded. Results Higher doses of CBL-514 (unit dose: 2.0 and 1.6 mg/cm 2) significantly improved the absolute and percentage reduction in abdominal fat volume (p<0.00001) and thickness (p<0.0001) compared to baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations. Conclusions CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm 2 is safe, well-tolerated and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. While other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm 2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, non-surgical abdominal fat reduction in dermatological clinics.

Bilobalide Induces Apoptosis in 3T3-L1 Mature Adipocytes through ROS-Mediated Mitochondria Pathway

“…Preadipocytes make up 15-50% of the adipose tissue [30]. Targeting adipocyte apoptosis to reduce the volume of adipose tissues by bioactive components [2,13,[31][32][33][34], surgical injection [35], and instrument intervention [36] are considered as promising strategies for combating obesity and its associated metabolic disorders.…”

Modern and Non-Invasive Methods of Fat Removal

“…CBL-514, reducing the volume of adipose tissue in the abdominal area by 24.96%, has become a promising solution in non-surgical fat reduction, as well as a safe, well-tolerated therapy. However, further studies, with a larger group of participants, and the introduction of a control group, are required to obtain more reliable treatment results [ 70 ].…”