CBL-514 / Caliway Biopharmaceuticals - LARVOL DELTA

Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat (PRNewswire) - "Caliway Biopharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multicenter, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localized fat reduction...Subject recruitment is expected to begin in Q3 2025 at 29 clinical sites across the United States and Canada, with a total of 300 participants randomized 1:1 to receive either CBL-514 or placebo...Caliway has also completed the Clinical Trial Application (CTA) submission for SUPREME-01 to Health Canada and is preparing to submit the second global pivotal Phase 3 study SUPREME-02 (CBL-0302) in the U.S., Canada, and Australia later this year. The topline results from SUPREME-01 are expected between Q4 2026 and Q1 2027....Caliway also plans to submit a Phase 2 IND application to the U.S. FDA in Q4 2025 for the combination of CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity..."

IND • New P3 trial • P3 data: top line • Metabolic Disorders • Obesity