- 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.
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