2025. 09
Date： 2025.09.19 -
Caliway Participates in EASD 2025 – CBL-514 Demonstrates Unique Fat-Reduction Mechanism and Differentiated Advantage in Combination with GLP-1R Therapy
- Caliway participated in the European Association for the Study of Diabetes (EASD) Annual Meeting held on September 15–18, 2025, engaging with multiple global pharmaceutical companies and industry experts to discuss CBL-514’s new indication: combination with GLP-1R agonists for weight management.
- Latest preclinical results showed that CBL-514, when combined with GLP-1R agonists, achieved significantly greater weight reduction compared to GLP-1R monotherapy: 50.5% additional weight loss after 4 weeks, and 166.1% additional reduction 3 weeks after GLP-1R discontinuation.
- Beyond enhanced weight loss, the combination therapy also showed significant advantages in reducing both subcutaneous fat (-182.5%) and visceral fat (-367.4%), mitigating post-discontinuation weight regain, supporting sustained weight control, and improving cardiometabolic risk factors.
- CBL-514 is a first-in-class drug candidate that reduces fat by inducing adipocyte apoptosis, enabling large-area, precise fat reduction. In July 2025, the U.S. FDA cleared initiation of the world’s first pivotal Phase 3 clinical study (SUPREME-01) with the indication of “abdominal subcutaneous fat reduction.”
- At this year’s EASD, major pharmaceutical companies focused their reports on “achieving greater fat reduction and pursuing combination therapies,” reflecting the latest trend in obesity drug development. With its robust data and unique mechanism, CBL-514 is well positioned to deliver the differentiated advantage that global pharmaceutical companies are urgently seeking in an increasingly competitive obesity treatment market.
New Taipei City, Sep 18, 2025 – Caliway Biopharmaceuticals (TWSE: 6919) participated in the European Association for the Study of Diabetes (EASD) Annual Meeting held in Vienna, Austria, from September 15 to 18, 2025. The company engaged in direct interactions with international pharmaceutical companies, industry experts, and KOLs, sharing new preclinical findings on the combination of CBL-514 with GLP-1 receptor agonists (widely known as GLP-1 “weight-loss injections”).
The 2025 EASD Annual Meeting focused on weight management and obesity treatment, serving as a major global platform for data exchange. The conference gathered leading multinational pharmaceutical companies and academic experts to discuss progress in GLP-1/GIP multi-target therapies and combination strategies, reflecting the increasingly competitive landscape and the urgent demand for differentiated solutions.
Although Caliway did not formally submit data for presentation at this year’s meeting, the company shared findings from two recently completed preclinical studies (OI22, OI23) with participating experts, highlighting four differentiated advantages of CBL-514 when combined with GLP-1R drugs such as Tirzepatide:
- Enhanced weight reduction: Combination therapy (OI23) achieved an additional 50.5% reduction in body weight compared to GLP-1R alone after 4 weeks.
- Direct reduction in adipocyte number: Unlike existing drugs that only shrink adipocyte size, CBL-514 induces adipocyte apoptosis, thereby fundamentally improving body composition.
- Mitigation of weight rebound: Data showed that after 4 weeks of combination therapy, body weight remained further reduced by 166.1% compared to monotherapy even after 3 weeks of GLP-1R discontinuation.
- Healthier weight management: Combination therapy achieved significantly greater reductions in subcutaneous fat (-182.5%) and visceral fat (-367.4%), contributing to improved body composition and cardiometabolic health.
Experts who reviewed the data commented, “CBL-514’s innovative mechanism creates a synergistic effect with GLP-1R agonists. These results not only accelerate weight loss and address the critical challenge of post-discontinuation rebound but also improve body composition through greater reduction of subcutaneous and visceral fat, providing added value for healthier and more sustainable weight management outcomes.”
Caliway also emphasized that clinical development of CBL-514 in localized fat reduction is progressing steadily.
In July, the FDA cleared the initiation of the pivotal Phase 3 SUPREME-01 study in abdominal subcutaneous fat reduction. In parallel, the company is advancing its weight management program and plans to submit a Phase 2 IND application to the FDA in Q1 2026 for the combination of CBL-514 with GLP-1R therapies.
Vivian Ling, Chief Executive Officer of Caliway, stated: “In today’s increasingly crowded obesity drug landscape, CBL-514 uniquely addresses the root cause by reducing adipocyte number. By combining with GLP-1R therapies, we believe this innovative approach can deliver a true 1+1>2 effect, offering global pharmaceutical partners and patients worldwide a differentiated and transformative weight-loss solution.”
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 help 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.