2025. 07
Date： 2025.07.11 -
Caliway Files Canadian CTA for Global Pivotal Phase 3 SUPREME-01 Study of CBL-514, with U.S.-Canada Recruitment to Begin in Q3
- Caliway has submitted the Clinical Trial Application (CTA) to Health Canada for SUPREME-01 (CBL-0301), a global, multicenter, pivotal Phase 3 study of CBL-514 for subcutaneous fat reduction, following the IND submission to the U.S. FDA.
- The primary estimand is a multicomponent responder endpoint with abdominal fat volume change measured by MRI and abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). The study design was agreed upon with the FDA at the EOP2 meeting.
- Subject recruitment for SUPREME-01 is expected to begin in the U.S. and Canada in Q3 2025, enrolling approximately 300 participants.
New Taipei City, July 11 2025 – Caliway Biopharmaceuticals (TWSE: 6919) today announced that following the completion of its IND submission to the U.S. Food and Drug Administration (FDA), it has officially submitted the Clinical Trial Application (CTA) to Health Canada for its first global, multicenter, pivotal Phase 3 study SUPREME-01 (CBL-0301) of CBL-514, the first investigational drug for large-area localized fat reduction. The study adopts the same design previously agreed with the U.S. FDA during the End-of-Phase 2 (EOP2) meeting and aims to evaluate the efficacy, safety, and tolerability of CBL-514 for the proposed indication of “Reduction of Abdominal Subcutaneous Fat,” serving as a key basis for a future New Drug Application (NDA).
SUPREME-01 Phase 3 is a randomized, double-blind, placebo-controlled study. The primary estimand is a multicomponent responder endpoint, comprising: (1) abdominal fat volume change measured by MRI, and (2) abdominal fat level change assessed by Patient Reported-Abdominal Fat Rating Scale (PR-AFRS). These endpoints were previously evaluated and met in Caliway’s completed Phase 2b studies, CBL-0204 and CBL-0205. The study is expected to enroll approximately 300 participants across nearly 30 clinical sites in the U.S. and Canada.
CBL-514 may become the world’s first 505(b)(1) lipolysis drug to be submitted for NDA filing with the specific indication of “Reduction of Abdominal Subcutaneous Fat.” With its innovative positioning and quantifiable efficacy endpoints, the parallel advancement of U.S. and Canadian applications not only reflects Caliway’s R&D strength and execution capabilities but also marks an important milestone in its ongoing global market and regulatory strategy.
About CBL-514
CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, 10 clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met.Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and Weight management (to reduce post-weight-loss fat rebound). CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum’s disease and more.