What Is CBL-514?
CBL-514 is an investigational drug, currently studied as a ready-for-use injectable solution. Based on the conditions it is being studied for, it is likely intended to affect subcutaneous fat or other fatty tissues. The specific mechanism of action of CBL-514 is not detailed in the available trial descriptions.
CBL-514 is not currently approved by the FDA. It is being investigated for several conditions, primarily those involving fat reduction or modification of fatty tissues. Research on CBL-514 began with the first trial in October 2020, with the latest trial expected to conclude in April 2026. A total of 13 clinical trials have been conducted or are ongoing, with 10 trials already completed. These studies have involved a total of 1,159 participants. All trials are sponsored by Caliway Biopharmaceuticals Co., Ltd.
Uses and Conditions Under Study
CBL-514 is being studied for its potential use in several conditions related to fat and tissue. The primary conditions under investigation are:
- Subcutaneous Fat: This refers to the layer of fat located just beneath the skin. CBL-514 is being studied in 9 trials for its potential to reduce or modify subcutaneous fat, suggesting it may be developed for body contouring or localized fat reduction.
- Cellulite: This common skin condition causes dimpling of the skin, often on the thighs, hips, buttocks, and abdomen. CBL-514 is being investigated in 2 trials for its effects on cellulite, where it is administered at the raised areas of cellulite.
- Dercum's Disease: This rare disorder is characterized by the growth of multiple, painful fatty tumors (lipomas) under the skin. CBL-514 is being studied in 2 trials for Dercum's disease, with dosing schemes tailored to the size of individual lipomas.
Dosing
CBL-514 is provided as a ready-for-use injectable solution. The dosage forms studied include CBL-514 injection, CBL-A1 Injection, and CBL-A2 Injection. The concentration of the solution has been noted as 5 mg/mL in some trials.
A wide range of doses and administration methods have been investigated across different studies. For conditions like Dercum's Disease, the total injection volume per lipoma is based on its size, with examples including 1 mL (5 mg CBL-514) for lipomas less than 10mm in diameter, and 3 mL (15 mg CBL-514) for lipomas between 10mm and 20mm. Other studied doses include single amounts such as 40 mg, 60 mg, 80 mg, 180 mg, 240 mg, 300 mg, 320 mg, 480 mg, 640 mg, and 800 mg. Some trials have also explored doses based on area, such as 1.2 mg/cm^2, 1.6 mg/cm^2, and 2 mg/cm^2. Cohort studies have evaluated doses ranging from 2 mg to 320 mg, often combined with specific area-based concentrations like 0.5 mg/cm^2, 1.0 mg/cm^2, or 2 mg/cm^2.
Side Effects
In a study evaluating CBL-514 for reducing subcutaneous fat (NCT04575467), specific percentages of patients experiencing side effects compared to a placebo were not provided in the available data. The following information details the number of participants who experienced certain events across different doses of CBL-514.
The most frequently reported event among participants was injection site reactions:
- 6 participants receiving 320 mg of CBL-514 reported injection site reactions.
- 7 participants receiving 480 mg of CBL-514 reported injection site reactions.
- 6 participants receiving 640 mg of CBL-514 reported injection site reactions.
- 6 participants receiving 800 mg of CBL-514 reported injection site reactions.
Regarding clinically significant abnormalities, one participant in the 800 mg dose group experienced an abnormality in clinical laboratory values. No participants across any dose (320 mg, 480 mg, 640 mg, or 800 mg) experienced clinically significant abnormalities in electrocardiogram (ECG) results, physical examinations, or vital signs.
The total number of treatment-emergent adverse events reported across the study doses were 103 events for 320 mg, 57 events for 480 mg, 69 events for 640 mg, and 61 events for 800 mg.
Clinical Trial Results
Clinical trial results for CBL-514 come from a study (NCT04575467) designed to evaluate its efficacy, safety, and tolerability for reducing subcutaneous fat. This study measured changes from baseline in subcutaneous fat thickness and volume across different dose levels of CBL-514. The provided data reflects mean reductions, and a direct comparison to a placebo group was not available in this specific dataset.
Reduction in Subcutaneous Fat Thickness
Patients treated with CBL-514 experienced a reduction in subcutaneous fat thickness:
- Those who received 480 mg of CBL-514 saw an average reduction of 4.77 mm from their baseline fat thickness.
- Participants treated with 640 mg of CBL-514 experienced the greatest average reduction in fat thickness, at 4.85 mm from baseline.
- The 800 mg dose of CBL-514 resulted in an average reduction of 2.98 mm from baseline fat thickness.
Reduction in Subcutaneous Fat Volume
Similarly, CBL-514 led to a decrease in subcutaneous fat volume:
- Patients receiving 480 mg of CBL-514 had an average reduction of 114.40 mL in fat volume from baseline.
- The 640 mg dose of CBL-514 showed the largest average reduction in fat volume, at 155.20 mL from baseline.
- For those treated with 800 mg of CBL-514, the average reduction in fat volume was 119.17 mL from baseline.
These results indicate that CBL-514, particularly at the 640 mg dose, led to measurable reductions in both the thickness and volume of subcutaneous fat in the study participants.