Phase 2b Study to Evaluate Safety and Effectiveness of CBL-514 Injection for Reducing Abdominal Fat Randomized, Placebo-Controlled with Up to Four Treatments Over Time

What this Trial Is About

Researchers are evaluating the effects of CBL-514 injection on reducing abdominal subcutaneous fat in adults with Grade 3 or Grade 4 abdominal fat. This phase 2b randomized, placebo-controlled study aims to assess the efficacy, safety, and tolerability of this treatment compared to a placebo. Approximately 250 participants with specific abdominal fat levels will be included to better understand this approach for fat reduction. Participants are randomly assigned to receive either CBL-514 injection or a placebo consisting of 0.9% Sodium Chloride. Each participant will undergo up to 4 subcutaneous treatments to the abdomen, spaced 3 weeks apart, with doses up to 120 mL per treatment. The study includes a long-term re-treatment phase to monitor effects over time. During the study, participants will be assessed for changes in abdominal fat using clinician and patient-reported scales at baseline and follow-up points up to 12 weeks after the final treatment. Safety and tolerability will also be monitored throughout. The primary outcome focuses on the percentage change in abdominal fat from baseline to 4 weeks after the last treatment. Participants will be involved in study visits for treatment administration and evaluations, with overall participation lasting several months.

A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat