A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.
Study Type
INTERVENTIONAL
Allocation
NON_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
Percentage of participants with at least 1 TEAE
Time frame: 6,9, and 12 months after last treatment of parent studies
Percentage of participants with at least 1 AESI
Time frame: 6,9, and 12 months after last treatment of parent studies
Percentage of participants who maintain 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)
Measured by 5-point ordinal scales from Grade 1 to Grade 5 for assessing the severity of abdominal fat. The higher the grade, the more the abdominal fat.
Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies
Percentage change from baseline in abdominal fat
Measured by MRI
Time frame: From baseline to 6,9, and 12 months after last treatment in parent studies
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