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 with Grade 3 or Grade 4 abdominal fat, as assessed by Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) and Patient Reported-Abdominal Fat Rating Scale (PR-AFRS) at 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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Provided as a ready for use injectable CBL-514 solution
Injectable 0.9% Sodium Chloride solution as placebo
Investigational Site 1
South Yarra, Victoria, Australia
RECRUITINGPercentage 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 change from Baseline in abdominal fat in the CBL-514 group versus the placebo group
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 in the CBL-514 group versus the placebo group
Measured by a 5-point rating 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 and 12 weeks after final treatment
Percentage of participants with at least a 1-grade improvement on Patient Reported-Abdominal Fat Rating Scale in the CBL-514 group versus the placebo group
Measured by a 5-point rating 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 and 12 weeks after final treatment
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