Participants experienced an average reduction of 28.1% of subcutaneous fat volume compared with placebo.
Caliway Biopharmaceuticals announced that clinical results from the CBL-0202 phase 2 study of its novel localized fat reduction drug, CBL-514, have been accepted for publication in the Aesthetic Surgery Journal. This publication further validates the efficacy and safety of CBL-514 in localized fat reduction, highlighting its clinical value as an innovative non-surgical therapy.
This follows the publication of the CBL-16001 phase 2a clinical results in the Aesthetic Surgery Journal in 2022.
Clinical results from the phase 2 CBL-0202 study revealed that eight weeks after the final treatment, over 60% of participants in the CBL-514 group achieved a reduction of at least 200mL of subcutaneous fat in the treated area, compared to 0% in the placebo group, achieving statistical significance (p< 0.0001).
Notably, 42.9% of these participants achieved at least a 150mL reduction in subcutaneous fat after only one treatment. Moreover, per-protocol analysis showed that participants experienced an average reduction of 28.1% of subcutaneous fat volume compared with placebo.
Fat Reduction Comparable to Liposuction
In comparison, according to a study published in the Aesthetic Surgery Journal in 2012, abdominal liposuction removed an average of 183mL of subcutaneous fat, indicating that CBL-514’s fat reduction efficacy could potentially surpass traditional liposuction. Additionally, the study demonstrated a favorable safety profile, with no severe adverse events reported.
Principal investigators emphasized that CBL-514 achieved a fat reduction effect comparable to liposuction, with significantly improved safety, shorter treatment duration, and no required downtime, “positioning CBL-514 as a promising alternative for non-invasive body contouring.”
“The acceptance of CBL-514’s phase 2 clinical data in ASJ once again affirms our research outcomes and capabilities, reinforcing CBL-514’s significant potential in the localized fat reduction market,” says Caliway’s CEO, Vivian Ling, in a release. “We will actively pursue further publications of CBL-0204 phase 2b results, to strengthen Caliway’s academic and commercial presence globally in the aesthetic medicine industry.”
Caliway will accelerate subject recruitment for two pivotal global phase 3 studies for localized fat reduction in Q3 2025, expanding international collaborations and steadily progressing toward the goal of developing an FDA-approved injectable drug for large-area localized fat reduction.
The study is expected to be officially published in Aesthetic Surgery Journal in Q2 2025.
ID 213521106 | Hospital © Kuprevich | Dreamstime.com
