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Caliway Submits CBL-514 for FDA Phase 2 Weight Management Trial
The Phase 2 trial will enroll about 120 adults with obesity or overweight to evaluate fat reduction, body composition, and long-term weight management using MRI and DEXA imaging.
- On Dec. 24, 2025, Caliway Biopharmaceuticals filed an IND with the U.S. FDA for a Phase 2 CBL-514 trial combined with Zepbound at multiple centers in the United States.
- Current GLP-1RA therapies primarily achieve weight loss through appetite suppression, limiting abdominal subcutaneous fat reduction, and patients discontinuing therapy often face post-discontinuation weight regain.
- Using a randomized, placebo-controlled design, the study will add CBL-514 after 8 weeks of tirzepatide monotherapy with six combination administrations, assessing MRI-measured abdominal subcutaneous fat and DEXA body composition, all read by a blinded third-party CRO.
- Pairing with Eli Lilly's tirzepatide ties the trial to a therapy with cumulative sales of USD 24.8 billion and expands Caliway R&D footprint in global weight management.
- CBL-514's mechanism targets adipocyte number via apoptosis, and animal study results presented on Dec. 14 showed it improves fat composition; Caliway reports 10 completed clinical trials with 544 subjects.
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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…
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