CBL-514 for Reducing Abdominal Fat

Overseen By Candra Chou

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, GLP-1 agonists

Disqualifiers: Coagulation disorders, Diabetes, Malignancies, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injection called CBL-514 to determine if it can safely reduce belly fat. Researchers aim to assess its effectiveness compared to a placebo, which is a harmless saltwater solution (0.9% Sodium Chloride). Individuals with moderate to severe belly fat, who haven't experienced recent weight changes or undergone fat-reduction treatments, might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking any weight reduction medications, GLP-1 agonists, and medications that strongly affect certain liver enzymes at least 2 days before and until 1 day after dosing. If you are on anticoagulant therapy or medications that affect blood clotting, you may not be eligible to participate.

Is there any evidence suggesting that CBL-514 Injection is likely to be safe for humans?

Research has shown that CBL-514 is generally safe for reducing belly fat. Studies have found it significantly decreases fat with only mild side effects. As a noninvasive treatment, it does not involve surgery, which typically enhances its safety profile. No reports of long-term or widespread negative effects exist. This makes CBL-514 a promising option for those seeking to reduce belly fat without major risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for reducing abdominal fat, which often involve invasive procedures like liposuction or non-invasive techniques such as cryolipolysis, CBL-514 is an injectable treatment that targets and breaks down fat cells directly. Researchers are excited about CBL-514 because it offers a non-surgical option with the potential for fewer side effects and quicker recovery times. Additionally, its mechanism involves administering a precise dose of 2 mg/cm², allowing for targeted and customizable fat reduction, which could lead to more tailored body contouring results.

What evidence suggests that CBL-514 Injection might be an effective treatment for reducing abdominal fat?

In this trial, participants will receive either CBL-514 injections or a placebo of 0.9% Sodium Chloride. Research has shown that CBL-514 injections can help reduce belly fat. Specifically, 69.6% of people who received CBL-514 in studies lost at least 150 mL of fat under the skin, while no one in the placebo group did. Another study found a 24.96% decrease in fat volume for those who received CBL-514. Additionally, between 58.3% and 60.9% of participants lost at least 200 mL of fat within 4 to 8 weeks after treatment. These results suggest that CBL-514 could be a promising non-invasive method to reduce unwanted belly fat. ^{1 4 6 7 8}

Who Is on the Research Team?

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

Adults aged 18-64 with a BMI between 18.5 and 32, weighing at least 50 kg, having mild to severe abdominal fat without significant weight change or lifestyle changes in the past three months. Participants must not be pregnant, lactating, or planning pregnancy; males must use condoms. Excludes those with coagulation disorders, uncontrolled diabetes, recent malignancies (except certain skin cancers), HIV infection, extreme fear of needles, abnormal abdominal conditions like hernias or scars.

Inclusion Criteria

Participant who has maintained a stable lifestyle (e.g., exercise, eating patterns, and smoking habit) per participant report for at least 3 months before Screening and during the study

My weight has been stable, with less than a 3 kg change, for the last 3 months.

Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg at Screening and Day 1

Exclusion Criteria

I am not pregnant or breastfeeding and agree to use birth control during the study and for 90 days after.

Participant has abnormal skin or local skin conditions at the treatment area, which, in the opinion of Investigator, would increase risk to the participant or inhibit safety or efficacy evaluation, including but not limited to any of the following

I have or had a hernia near my belly button.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 treatments of CBL-514 or placebo administered subcutaneously to the abdomen every 3 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 0.9% Sodium Chloride
• CBL-514 Injection

Trial Overview

The study is testing CBL-514 injections against a placebo (0.9% Sodium Chloride) to see if it can reduce belly fat effectively and safely. This Phase 2b trial randomly assigns participants to receive either the real injection or a fake one without knowing which they're getting.

How Is the Trial Designed?

Group I: CBL-514 Injection Experimental Treatment 1 Intervention

Participant will receive CBL-514 2 mg/cm² administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments.

Group II: 0.9% Sodium Chloride Placebo Group 1 Intervention

Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to a maximum of 4 treatments.

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+

Published Research Related to This Trial

The latest practice advisory on gluteal fat grafting emphasizes the importance of surgical technique to prevent fatal complications, particularly in Brazilian Butt Lifts (BBL), which have been linked to several patient deaths.

Key recommendations include using ultrasound guidance for fat injection to ensure correct placement and limiting surgeons to a maximum of 3 BBL procedures per day to reduce fatigue and distraction, which are associated with increased surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Advisory on Gluteal Fat Grafting. Del Vecchio, D., Kenkel, JM.[2022]

CBL-514, an injectable drug, was found to be safe and effective in reducing abdominal subcutaneous fat volume and thickness, with a significant reduction of 24.96% at the highest dose of 2.0 mg/cm2.

The treatment induced adipocyte apoptosis, which is the mechanism by which it reduces fat, and was well-tolerated across multiple doses, making it a promising option for nonsurgical fat reduction in dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Goodman, GJ., Ho, WWS., Chang, KJ., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12080885/

Efficacy and Safety of CBL-514 Injection in Reducing ...

CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, ...

2.

academic.oup.com

academic.oup.com/asj/advance-article/doi/10.1093/asj/sjaf032/8051634

Efficacy and Safety of CBL-514 Injection in Reducing ...

At 8 weeks post-final treatment, 69.6% of CBL-514-treated participants lost ≥150mL subcutaneous fat, compared with none in the placebo group (p< ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9384315/

A Randomized, Phase IIa Study of CBL-514 Injection on ...

At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical ...

4.

caliwaybiopharma.com

caliwaybiopharma.com/en/news-detail/cbl-0202-met-efficacy-endpoints/

Caliway's CBL-514 Achieved Better Efficacy than ...

58.3% and 60.9% of participants in the CBL-514 group lost at least 200 mL of subcutaneous fat over the treated area at 4 weeks and 8 weeks after treatment; ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06005441

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04897412

NCT04897412 | A Study to Evaluate the Efficacy, Safety ...

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2). ClinicalTrials.gov ID NCT04897412.

7.

caliwaybiopharma.com

caliwaybiopharma.com/en/research/15/

CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd

CBL-514 Injection​​ Demonstrates favorable safety and tolerability profiles, with mild side effects, no sequelae or systemic side effects. Delivers significant ...

8.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378399

ANZCTR - Registration

CBL-514 will be administered via injection into the abdominal subcutaneous adipose layer. Eligible subjects will be randomized to 1 of 3 treatment groups: ...