CBL-514 for Subcutaneous Fat
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called CBL-514 to understand how the body absorbs and processes it. Researchers administer CBL-514 as a single injection to healthy volunteers to assess its safety and any side effects. The trial seeks participants with a bit of extra belly fat, easily measurable with a skinfold caliper. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as those that affect blood clotting, certain steroids, and specific drugs that interact with liver enzymes. If you need to use these medications, you should stop at least 2 days before and until 1 day after the study dose.
Is there any evidence suggesting that CBL-514 is likely to be safe for humans?
Research has shown that CBL-514 is generally safe and well-tolerated by patients. Studies have demonstrated its effectiveness in reducing fat without causing serious side effects. Most reported side effects, such as bruising or reactions at the injection site, are mild. Another study confirmed that CBL-514 was safe and well-tolerated, even at different doses. Overall, several studies have indicated a positive safety record for CBL-514, suggesting it is a safe option for those considering joining a trial.12345
Why do researchers think this study treatment might be promising?
CBL-514 is unique because it is administered directly into the subcutaneous tissue of the abdomen, targeting localized fat deposits. While most treatments for fat reduction involve invasive procedures like liposuction or energy-based devices, CBL-514 offers a non-invasive alternative through multiple small injections. Researchers are excited about this treatment because it has the potential to offer precise fat reduction with minimal downtime, providing a convenient option for those seeking to refine their body contour without surgery.
What evidence suggests that CBL-514 might be an effective treatment for the condition being studied?
Research has shown that CBL-514 can help reduce subcutaneous belly fat. In one study, CBL-514 injections safely and effectively reduced both the amount and thickness of this fat. Another study found that 69.9% of participants lost at least 150mL of belly fat, and 60.9% lost 200mL after using CBL-514. These results suggest that CBL-514 could be a promising option for reducing belly fat. Participants in this trial will receive a single course of treatment with CBL-514 to further evaluate its effectiveness.46789
Who Is on the Research Team?
Anne Sheu
Principal Investigator
Caliway Biopharmaceuticals Co., Ltd.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single course of CBL-514 800 mg administered as multiple subcutaneous injections on the abdomen on Day 1
Pharmacokinetic Assessment
Evaluate pharmacokinetic parameters including Cmax, AUC, t1/2, CL/F, and Vz/F with 12 time points on Day 1 and Day 2
Follow-up
Participants are monitored for treatment-related adverse events and clinically significant abnormalities in various health parameters
What Are the Treatments Tested in This Trial?
Interventions
- CBL-514
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All 10 participants enrolled in the study will receive a single course of treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm\^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.
CBL-514 is already approved in European Union, United States for the following indications:
- Dercum's disease
- Dercum's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Caliway Biopharmaceuticals Co., Ltd.
Lead Sponsor
Citations
A Randomized, Phase IIa Study of CBL-514 Injection on ...
Our results show that CBL-514 is safe, well-tolerated, and effectively reduces abdominal subcutaneous fat volume and thickness at multiple doses up to 2.0 mg/cm ...
NCT04698642 | A Study to Evaluate the Safety, Tolerability ...
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat.
Efficacy and Safety of CBL-514 Injection in Reducing ...
A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.
NCT06005441 | A Phase 2b Study to Evaluate the Efficacy ...
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 ...
Caliway's CBL-514 Achieved Better Efficacy than ...
- 69.9% and 60.9% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after CBL-514 treatment. - Compared with ...
Efficacy and Safety of CBL-514 Injection in Reducing ...
A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.
CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd
Side effects such as bruising or local reactions are generally mild. CBL-514's Phase 2 study for moderate to severe cellulite (CBL-0201EFP Phase 2) met all ...
Caliway Announces CBL-514 Second Phase 2b Study ...
Overall, the safety and tolerability profiles of CBL-514 demonstrated in the study were favorable and consistent with previous clinical studies ...
A Study to Evaluate the Efficacy and Safety of CBL-514 in ...
This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.