This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.
A total of approximately 160 adult participants with moderate or severe abdominal fat at Screening 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
DOUBLE
Enrollment
173
Provided as a ready for use injectable CBL-514 solution
Provided as a ready for use injectable CBL-A1 solution
Provided as a ready for use injectable CBL-A2 solution
Investigational Site 1
Omaha, Nebraska, United States
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with placebo
Measured by MRI
Time frame: From Baseline to 4 weeks after the final treatment
Percentage of participants with at least 20% subcutaneous fat change compared to Baseline, of CBL-514 compared with CBL-A1 and CBL-A2
Measured by MRI
Time frame: From Baseline to 4 weeks after the final treatment
Participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
The scale is a 5-point ordinal scale to assess the abdominal fat level
Time frame: From Baseline to 4 weeks after the final treatment
Participants with at least 2-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS)
The scale is a 5-point ordinal scale to assess the abdominal fat level
Time frame: From Baseline to 4 weeks after the final treatment
Participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
The scale is a 5-point ordinal scale to assess the abdominal fat level
Time frame: From Baseline to 4 weeks after the final treatment
Participants with at least 2-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS)
The scale is a 5-point ordinal scale to assess the abdominal fat level
Time frame: From Baseline to 4 weeks after the final treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sodium Chloride (0.9% NaCl) placebo for injection