What is the mechanism of action of this treatment?

Common treatments for reducing subcutaneous fat, such as the CBL-514 injection, typically work by breaking down fat cells through various mechanisms. Injectable agents like CBL-514 may use lipolysis, where the injected substance disrupts the fat cell membrane, leading to the release and subsequent metabolism of stored fat. This process reduces the volume of fat in the treated area. Other non-invasive treatments, such as laser therapy or ultrasound, use thermal or mechanical energy to target and destroy fat cells. These treatments are significant for patients as they offer targeted fat reduction with minimal invasiveness, providing an alternative to surgical procedures like liposuction.

What side effects are associated with this type of intervention?

Injectable treatments for reducing subcutaneous fat, such as the CBL-514 injection, are generally well-tolerated but can have some side effects. Common side effects include localized reactions at the injection site such as pain, erythema (redness), bruising, and swelling. In some cases, patients may experience temporary numbness or firmness in the treated area. Serious side effects are rare but can include infection or allergic reactions. It is important to discuss these potential risks with a healthcare provider before undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for the reduction of subcutaneous fat, primarily focusing on injectable therapies. One notable example is deoxycholic acid (Kybella), which is used to reduce fat under the chin by breaking down fat cells. Another treatment is cryolipolysis (CoolSculpting), a non-invasive procedure that uses cooling to reduce fat deposits. These treatments share similarities with the CBL-514 injection being studied, as they all aim to reduce localized fat deposits through minimally invasive methods.

What other types of research exist?

Promising, novel alternatives to CBL-514 injection for reducing subcutaneous fat include cryolipolysis, radiofrequency ablation, and low-level external laser therapy. These noninvasive body sculpting technologies have shown efficacy, safety, and tolerability in clinical studies.

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CBL-514 for Reducing Abdominal Fat

Phase 2

Waitlist Available

Research Sponsored by Caliway Biopharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 4 weeks and 8 weeks after the final treatment

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here for CBL-514 Injection, common ones for similar treatments include reactions at the injection site such as pain or swelling, nausea, potential allergic reactions and possibly systemic effects depending on how the drug works.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 4 weeks and 8 weeks after the final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 4 weeks and 8 weeks after the final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4 weeks and 8 weeks after the final treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in subcutaneous fat compared to baseline

Participants with at least 1-grade improvement reported by Investigator using the Clinician-Reported Abdominal Fat Rating Scale

Participants with at least 1-grade improvement reported by participant using the Patient-Reported Abdominal Fat Rating Scale

+1 more

Other study objectives

Incidence of clinically significant abnormal findings

Incidence of treatment-emergent adverse events (TEAEs)

Percentage of participants with at least 1-grade improvement reported by Investigator via live evaluation using CR-AFRS

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CBL-514 InjectionExperimental Treatment1 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 ChloridePlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBL-514 Injection

2022

Completed Phase 2

~190

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for reducing subcutaneous fat, such as the CBL-514 injection, typically work by breaking down fat cells through various mechanisms. Injectable agents like CBL-514 may use lipolysis, where the injected substance disrupts the fat cell membrane, leading to the release and subsequent metabolism of stored fat. This process reduces the volume of fat in the treated area. Other non-invasive treatments, such as laser therapy or ultrasound, use thermal or mechanical energy to target and destroy fat cells. These treatments are significant for patients as they offer targeted fat reduction with minimal invasiveness, providing an alternative to surgical procedures like liposuction.