FDA clears Caliway’s CBL-514 for SUPREME-01 study for reducing abdominal subcutaneous fat

Caliway Biopharmaceuticals has announced that the FDA has granted clearance to proceed with SUPREME-01 (CBL-0301), a global, multi-centre, pivotal Phase 3 study of CBL-514, the first investigational drug for large-area localised fat reduction. This milestone marks a critical step forward in Caliway's global regulatory strategy for CBL-514.

SUPREME-01 is a randomised, double-blind, placebo-controlled Phase 3 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.

Subject recruitment is expected to begin in third quarter 2025 at 29 clinical sites across the US and Canada, with a total of 300 participants randomized 1:1 to receive either CBL-514 or placebo.

CBL-514, a 505(b)(1) and first-in-class small-molecule drug and 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, ten clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met.

CBL-514 is the first 505(b)(1) investigational drug with FDA clearance to enter Phase 3 for the proposed indication of "Reduction of Abdominal Subcutaneous Fat." If approved, it may offer a novel therapeutic option beyond traditional aesthetic treatments, which have long been approved solely for "improvement in appearance," potentially offering greater medical value and expanded market opportunities.

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 US, Canada and Australia later this year. The topline results from SUPREME-01 are expected between the fourth quarter 2026 and the first quarter in 2027.

In addition, Caliway also plans to submit a Phase 2 IND application to the US FDA in the fourth quarter of 2025 for the combination of CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity, for the maintenance of weight loss, thereby expanding the therapeutic landscape of CBL-514 and entering the high-demand global weight management market.