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 320 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 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
320
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
Aventura, Florida, United States
Investigational Site 3
Alpharetta, Georgia, United States
Percentage of participants achieving at least a 2-grade improvement from baseline on Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) and a clinically meaningful reduction in abdominal fat.
Measured by a 5-point ordinal scale and MRI
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
Hunt Valley, Maryland, United States
Investigational site 5
Omaha, Nebraska, United States
Investigational site 6
New York, New York, United States
Investigational Site 7
Canal Winchester, Ohio, United States
Investigational site 8
Nashville, Tennessee, United States
Investigational site 9
Austin, Texas, United States
Investigational Site 10
Arlington, Virginia, United States
...and 4 more locations