A phase 2b, randomized, placebo-controlled study with long-term re-treatment to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.
A total of approximately 250 adult participants who have completed CBL-0206 stage 1 study with greater than Grade 1 abdominal fat, as assessed by Clincian Reported-Abdominal Fat Rating Scale (CR-AFRS) and Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) at stage 1 last follow-up visit and stage 2 baseline 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Provided as a ready for use injectable CBL-514 solution
Investigational Site 1
South Yarra, Victoria, Australia
Percentage change of abdominal fat
Measured by MRI
Time frame: From baseline to 4 weeks after final treatment
Percentage change of abdominal fat
Measured by MRI
Time frame: From baseline to 12 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS)
Measured by a 5-point ordinal scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.
Time frame: From baseline to 4 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on Patient Reported-Abdominal Fat Rating Scale (PR-AFRS)
Measured by a 5-point ordinal scale from Grade 1 to Grade 5 for assessing the severity of abdominal fat. Lower score indicates less abdominal fat. Higher score indicates more abdominal fat.
Time frame: From baseline to 4 weeks after final treatment
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