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A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
475 Total Patients Enrolled
6 Trials studying Subcutaneous Fat
398 Patients Enrolled for Subcutaneous Fat
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
6 Previous Clinical Trials
337 Total Patients Enrolled
3 Trials studying Subcutaneous Fat
290 Patients Enrolled for Subcutaneous Fat