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

107 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug CBL-514 for reducing abdominal fat?

Research suggests that CBL-514, a new injectable drug, may be safe and effective for reducing localized abdominal fat. This is based on a study that specifically looked at its use for this purpose. ^{1 2 3 4 5}

Is CBL-514 safe for reducing abdominal fat?

CBL-514 is described as potentially safe for reducing localized abdominal fat, according to a study on its use for this purpose. ^{1 2 6 7 8}

How is the drug CBL-514 unique for reducing abdominal fat?

CBL-514 is a novel injectable drug that targets and induces the death of fat cells specifically in the abdominal area, offering a localized approach to fat reduction, which is different from other non-invasive treatments like cryolipolysis or laser therapy that use cold or light to reduce fat. ^{1 2 3 9 10}

What is the purpose of this trial?

This trial is testing a new injection called CBL-514 to reduce belly fat in adults who have noticeable abdominal fat. The treatment works by breaking down fat cells in the targeted area, helping to slim down the belly.

Research Team

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria

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

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

My doctor has rated my abdominal fat as moderate or severe.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of abdominal adipose panniculus in patients treated with a single session of cryolipolysis in a clinical setting. [2022]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Non-invasive cryolipolysis for body contouring in Chinese--a first commercial experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing the Appearance of the "Six-Pack" Muscles Using Cryolipolysis: A Safe and Effective Method. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Rimonabant: new drug. Obesity: loss of a few kilos, many questions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Practice Advisory on Gluteal Fat Grafting. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The endocannabinoid system: a new target for the regulation of energy balance and metabolism. [2018]

9. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Combination of Red, Infrared and Blue Wavelengths of Low-Level Laser on Reduction of Abdominal Girth: A Before-After Case Series. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Loss of subcutaneous fat in 20 patients, both sexes, using a second-generation TECAR device of 1.240 Watts and results analyzed with magnetic resonance. [2023]