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

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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called CBL-514, which is injected into the fat layer under the skin of the abdomen. The goal is to reduce abdominal fat in people who have accumulated fat in this area. The treatment works by breaking down fat cells, and participants will receive up to four treatments over a period of time. CBL-514 is a new injectable drug that has shown promise in reducing abdominal fat.

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.

Research Team

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria

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

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)

Treatment Details

Interventions

• CBL-514
• CBL-514 Injection
• Placebo

Participant Groups

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+