FDA Clears Caliway’s Phase 3 CBL-514 Trial for Abdominal Fat Reduction
Caliway Biopharmaceuticals announced that the US Food and Drug Administration (FDA) cleared the Investigational New Drug application for CBL-0302, also known as SUPREME-02, its second global pivotal phase 3 study of CBL-514 for abdominal subcutaneous fat reduction.1
The IND passed the FDA’s 30-day review period on May 18, according to the company. Caliway said it plans to begin CBL-0302 and its other global pivotal phase 3 study, CBL-0301, in the near term, with clinical results expected in 2027.
Study to Use MRI-Based Fat Volume Endpoint
CBL-0302 is designed as a randomized, double-blind, placebo-controlled trial enrolling approximately 320 participants in the United States, Canada, and Australia. The study will evaluate the efficacy, safety, and tolerability of CBL-514 injection. Clinical study applications have also been submitted in Canada and Australia.
The study’s primary efficacy endpoints include change in abdominal subcutaneous fat volume measured by MRI and abdominal fat level improvement assessed by the Patient-Reported Abdominal Fat Rating Scale. Caliway said the trial design is supported by prior phase 2b studies, CBL-0204 and CBL-0205, which met their primary endpoints.
The company also announced that Taiwan’s Food and Drug Administration approved CBL-0206, an Asia-Pacific phase 2 study of CBL-514, on May 19. The study is expected to enroll approximately 250 participants in Taiwan and Australia and will evaluate MRI-based fat volume change and abdominal fat rating outcomes.
CBL-514 is a small-molecule injectable lipolysis candidate in development for nonsurgical localized fat reduction and moderate-to-severe cellulite.
“To date, 10 clinical trials involving 544 subjects have been completed, meeting all efficacy and safety endpoints,” the company stated.
Source
Caliway Biopharmaceuticals. Caliway announces U.S. FDA IND clearance for CBL-0302, its second global pivotal phase 3 study of CBL-514. News release. May 2026.