Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment

Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in combination with tirzepatide. The protocol amendment for the pivotal Phase 3 clinical trial SUPREME-01 has been approved by the North American central Institutional Review Board (IRB) in the US, officially initiating subject enrollment.

Breakthrough research demonstrating CBL-514's efficacy in reducing visceral fat has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 30, 2026 (local time).

Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment.

The CBL-0201WR study is a randomized, single-blind, placebo-controlled trial designed to "reduce abdominal subcutaneous fat in overweight or obese adults," with an anticipated enrollment of 120 subjects in the U.S. The trial will use magnetic resonance imaging (MRI) to precisely measure volumetric changes in abdominal subcutaneous fat volume to evaluate the efficacy, safety, and tolerability of CBL-514 combined with Tirzepatide. The exploratory endpoints will also assess key indicators such as body weight, visceral fat, and lean body mass.

With the growing popularity of GLP-1 receptor agonists, the global weight management markets are rapidly shifting towards a post-weight management era focused on "post-treatment maintenance," "body composition improvement," and "metabolic health." While current mainstream GLP-1 drugs effectively suppress appetite, they only temporarily shrink fat cells, leading to a high risk of weight regain and an inability to eliminate stubborn localized fat after discontinuation. CBL-514's unique mechanism of "action selectively induces adipocyte apoptosis" fundamentally reduces the number of fat cells. The powerful combination of these two drugs is expected not only to help patients eliminate stubborn localized fat in areas like the abdomen on top of general weight loss but also to address the dual crisis of post-treatment weight rebound, potentially achieving a synergistic effect where 1 + 1 > 2.

The clearance of CBL-0201WR IND marks CBL-514's formal expansion from local fat reduction into the post-weight management market centered on "post-treatment maintenance," "body composition improvement," and "metabolic health."

Concurrently, significant progress has been made on the pivotal Phase 3 clinical trial SUPREME-01 which has received IRB approval in the U.S. and enrollment has now commenced. This trial is designed to evaluate the efficacy of CBL-514 for large-area abdominal fat reduction. If the trial successfully meets its endpoints, CBL-514 could become the world's first and only revolutionary drug administered via non-surgical injection to achieve a 2-grade improvement on the Abdominal Fat Rating Scale (AFRS). Academic Breakthrough Research Gains Further International Recognition, with Data on CBL-514's Combined Weight Loss and Visceral Fat Reduction Data Selected for EASD.