A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
A total of approximately 300 adult participants with moderate or severe abdominal fat at Baseline 1 will be enrolled. Each participant will receive up to 4 treatments of allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Provided as a ready for use injectable CBL-514 solution
Injectable 0.9% Sodium Chloride solution as placebo
Investigational site 1
Encinitas, California, United States
Investigational site 2
West Palm Beach, Florida, United States
Investigational site 3
Chicago, Illinois, United States
Percentage of participants with at least 13% abdominal fat change and at least a 2-grade improvement on Patient Reported Abdominal Fat Rating Scale (PR-AFRS) in the CBL-514 group versus the placebo group.
Measured by MRI and a 5-point ordinal scale
Time frame: From baseline to 4 weeks after final treatment
Percentage change from baseline in abdominal fat in the CBL-514 group versus the placebo group.
Measured by MRI
Time frame: From baseline to 4 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on both Participant Reported Abdominal Fat Rating Scale (PR-AFRS) and Clinician Reported Abdominal Fat Rating Scale (CR-AFRS) in the CBL-514 group versus the placebo group.
Measured by 5-point ordinal scales
Time frame: From baseline to 4 weeks after final treatment
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Investigational site 4
Baton Rouge, Louisiana, United States
Investigational site 5
Hunt Valley, Maryland, United States
Investigational site 6
Omaha, Nebraska, United States
Investigational site 7
Hackensack, New Jersey, United States
Investigational site 8
New York, New York, United States
Investigational site 9
Charlotte, North Carolina, United States
Investigational site 10
Nashville, Tennessee, United States
...and 3 more locations