Caliway’s Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies

• Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2).
• The study will evaluate CBL-514 in combination with Zepbound^® (Eli Lilly) in subjects with obesity or overweight.
• Efficacy endpoints include changes in abdominal subcutaneous fat volume (measured by MRI) and changes in body weight.
• The study design incorporates a long-term follow-up period after discontinuation of tirzepatide, focusing on key parameters relevant to long-term weight management.

NEW TAIPEI CITY, Dec. 24, 2025 /PRNewswire/ — Caliway Biopharmaceuticals (TWSE: 6919) today announced that it has completed the submission of an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2 clinical study of its world’s first large-area localized fat reduction drug candidate, CBL-514, for the weight management indication. This submission accelerates the clinical development of CBL-514 in combination with GLP-1R agonist (GLP-1RA) therapies and expands the Company’s R&D footprint in the global weight management field.

CBL-0201WR is a randomized, placebo-controlled Phase 2 study to be conducted at multiple centers in the United States. The study is expected to enroll approximately 120 subjects with obesity (BMI > 30) or overweight (BMI > 27) with comorbidities.

The study will evaluate the efficacy, safety, and tolerability of CBL-514 in combination with Zepbound^® (tirzepatide, a dual GLP-1/GIP receptor agonist, Eli Lilly). Following discontinuation of both tirzepatide and CBL-514, subjects will undergo longitudinal follow-up to assess abdominal subcutaneous fat changes, body weight changes, fat mass and body composition–related parameters.

Efficacy endpoints include changes in abdominal subcutaneous fat volume measured by MRI and changes in body weight. The study will also collect body composition data using DEXA (dual-energy X-ray absorptiometry), including body fat percentage, visceral fat, and muscle mass. To reduce bias, MRI and DEXA data will be read and analyzed in a blinded and independent manner by a third-party CRO before subsequent statistical analyses are performed.

In recent years, GLP-1RA weight-loss drugs have seen rapid adoption, driving significant growth in the global weight management market. International focus is shifting from achieving large-magnitude weight reduction toward greater fat reduction, post-discontinuation weight maintenance, body composition improvement, and long-term, healthy weight management outcomes.

Current GLP-1RA therapies primarily achieve weight loss through appetite suppression. Clinical evidence indicates that, while these therapies can substantially reduce body weight, they mainly shrink adipocyte size and do not reduce adipocyte number. Their effects on abdominal subcutaneous fat reduction also remain limited. Moreover, during treatment, profound appetite suppression induces a prolonged negative energy balance, triggering compensatory mechanisms and the intrinsic “memory” of adipocytes to restore their size. Once appetite returns after treatment discontinuation, these shrunken adipocytes may preferentially re-accumulate energy, undergo rapid enlargement and expansion, and be accompanied by increased visceral fat accumulation and deterioration of metabolic indicators, including insulin resistance.

Consequently, after discontinuing treatment, patients may experience weight regain alongside worsening metabolic parameters and adverse changes in body composition. This creates a dual challenge of weight rebound and body composition deterioration, which may offset the health benefits achieved during the weight loss period and has emerged as a key unresolved challenge in weight management.

CBL-0201WR is designed to address these unmet needs. In the study, CBL-514 will be added after 8 weeks of tirzepatide monotherapy, with six combination administrations. After the treatment period ends, subjects will be assessed at multiple time points during follow-up. The study will evaluate abdominal subcutaneous fat, body weight changes, fat mass (including total subcutaneous fat and visceral fat), and body composition–related parameters, providing important reference data for subsequent clinical and product development.

For the weight management application, CBL-514 acts not only through selective induction of adipocyte apoptosis, directly targeting adipocytes, but also, based on completed studies, has been shown to inhibit adipogenesis and promote fat metabolism. Distinct from GLP-1RA therapies that primarily regulate appetite and energy intake, CBL-514 may offer a novel mechanism of action and potential complementarity when studied in combination. 

Data from multiple animal studies have demonstrated that CBL-514, whether used alone or in combination with GLP-1RA therapies, has the potential to improve fat composition and support weight maintenance. The latest animal study results were presented on December 14 at the 25th Annual Congress of the Taiwan Medical Association for the Study of Obesity (TMASO 2025), held jointly with the 9th Japan–Korea–Taiwan Symposium on Obesity. The study, titled “Combination CBL-514 and Tirzepatide Synergistically Enhances Adiposity Reduction and Maintains Weight Loss After Tirzepatide Withdrawal,” was delivered as an oral presentation by Dr. Tzu-Jung Chou of National Taiwan University Hospital Hsinchu Branch, and was highlighted as one of the featured presentations at this year’s TMASO meeting, attracting attention from both academic and industry communities.

According to market data, cumulative sales of tirzepatide reached approximately USD 24.8 billion in the first three quarters of 2025. Morgan Stanley Research projects that the global weight-loss drug market could reach approximately USD 150 billion by 2035, representing a compound annual growth rate of around 25 percent. These projections highlight the significant market opportunity for differentiated weight management therapies with innovative mechanisms and long-term management capabilities.

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 with no systematic safety risks identified and well tolerated. 

To date, 10 clinical trials with a total of 544 subjects have been completed with all efficacy and safety endpoints met.

CBL-514 is being developed across multiple indications, including reduction of subcutaneous fat (non-surgical localized fat reduction), moderate-to-severe cellulite, and weight management. 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.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: https://www.caliwaybiopharma.com/en/

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ir@caliwaybiopharma.com

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