CBL-514 Injection for Subcutaneous 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 visit 2 (baseline) up to 8 weeks after last treatment

Summary

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from visit 2 (baseline) up to 8 weeks after last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from visit 2 (baseline) up to 8 weeks after last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 2 (baseline) up to 8 weeks after last treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of subjects who lose at least 150 mL of subcutaneous fat compared with placebo

Secondary study objectives

Change of subcutaneous fat volume over the treated area compared with placebo

Change of subcutaneous fat volume over the treated area of the CBL-514 group compared with individual baseline

Evaluation of safety following up to 4 courses of CBL-514 compared with placebo

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CBL-514 InjectionExperimental Treatment1 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 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 4 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

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