Caliway Received First Approval of CBL-514 Pivotal Phase 3 Study Application for Subcutaneous Fat Reduction
NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway's application to initiate CBL-514's Pivotal Phase 3 study (CBL-0301 Phase 3) for subcutaneous fat reduction.
- NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway's application to initiate CBL-514's Pivotal Phase 3 study (CBL-0301 Phase 3) for subcutaneous fat reduction.
- The CBL-0301 Pivotal Phase 3 study is a multicountry and multicenter study that will recruit 300 subjects to evaluate CBL-514's efficacy, safety, and tolerability for reducing abdominal subcutaneous fat.
- Caliway will submit the final Pivotal Phase 3 study protocol as soon as the preliminary result of the CBL-0204 Phase 2b study is announced.
- Caliway will also prepare to submit the IND application of another CBL-514's Pivotal CBL-0302 Phase 3 study for subcutaneous fat reduction.