CBL-514 for Reducing Abdominal Fat

No longer recruiting at 11 trial locations

Overseen By Candra Chou

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets, Steroids, others

Disqualifiers: Diabetes, Cardiovascular disease, HIV, others

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

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new injection, CBL-514, in reducing unwanted subcutaneous fat, particularly around the abdomen. Researchers aim to determine the treatment's safety, effectiveness, and participant satisfaction. Participants will receive either the CBL-514 injection or a placebo. This trial suits adults aged 18-64 with stable weight and noticeable abdominal fat. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

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, weight reduction drugs, and some other specific medications. 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 Injection is generally safe. Studies have found it effectively reduces belly fat without causing serious side effects. Most side effects were mild and temporary, affecting only the treated area. No reports indicated side effects impacting the entire body. Overall, patients in previous studies have tolerated CBL-514 well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional fat reduction treatments like liposuction or CoolSculpting, which physically remove or freeze fat cells, CBL-514 works by breaking down fat at a cellular level. This innovative injection contains a unique compound that targets and disrupts fat cell membranes, leading to their gradual breakdown and metabolism by the body. Researchers are excited about CBL-514 because it offers a less invasive option with the potential for fewer side effects and shorter recovery times compared to surgical alternatives. Additionally, its targeted mechanism may allow for more precise body contouring, appealing to individuals seeking more controlled results.

What evidence suggests that CBL-514 might be an effective treatment?

Research has shown that CBL-514 injections, which participants in this trial may receive, can help reduce subcutaneous fat. In one study, 42.9% of participants who received CBL-514 lost at least 150mL of fat after just one treatment. This noninvasive treatment, which does not involve surgery, is considered safe. CBL-514 targets fat beneath the skin and can improve the appearance of areas like the belly. Results may appear in as little as four weeks. ^{1 2 3 4 6}

Who Is on the Research Team?

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has stable body weight (identified as ≦ 5% weight change per subject report) for at least 3 months before Screening and during the study.

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

Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.

Exclusion Criteria

Subjects with any renal impairment, defined as abnormal serum creatinine, and urea > 1.5 × ULN or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.

Subject who has undergone the following procedures: Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study, except laparoscopic surgery and surgery which causes very small scar tissues would be eligible as per Investigator's discretion, Liposuction to the region to be treated before Screening or during the study, Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study. Subject is on prescription or OTC weight reduction medication or weight reduction programs within 3 months before Screening or during the study.

Requiring continual use of the following therapeutic agents during the study: terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.

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 via injection every 4 weeks

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CBL-514
• CBL-514 Injection
• Placebo

How Is the Trial Designed?

Group I: CBL-514 Injection Experimental Treatment 1 Intervention

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

Group II: Placebo: 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 4 weeks for up to a maximum of 4 treatments.

CBL-514 is already approved in European Union, United States for the following indications:

Approved in European Union as CBL-514 for:

• Dercum's disease

Approved in United States as CBL-514 for:

• Dercum's disease

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+

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 ... Of the 28 participants in CBL-514 group (N=50) who lost ≥150mL subcutaneous fat, 42.9% (12/28 participants) achieved this target after a single ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04698642

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.

4. caliwaybiopharma.com caliwaybiopharma.com/en/research/15/

CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd CBL-514 can precisely reduce localized superficial fat through subcutaneous injection, improving the appearance of cellulite without causing fibrosis, nodules, ...

5. biospace.com biospace.com/press-releases/caliway-announces-cbl-514-second-phase-2b-study-results-cbl-0205-met-endpoints

Caliway Announces CBL-514 Second Phase 2b Study ... These results highlight that CBL-514 effectively reduces subcutaneous fat and delivers noticeable improvements within four weeks, as reported ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05736107

NCT05736107 | A Study to Evaluate the Efficacy, Safety ... This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.