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Caliway Secures FDA IND Clearance for CBL-514–Tirzepatide Phase 2 Trial, Advances ...
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Fusion42 · 27 August 2026 · Fusion42 review
Caliway has secured FDA IND clearance for its Phase 2 trial combining CBL-514 with tirzepatide and initiated enrollment for its pivotal Phase 3 trial SUPREME-01 targeting large-area abdominal fat reduction. Additionally, CBL-514 visceral fat reduction data was selected for presentation at a major diabetes conference in 2026.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 26 Aug 2026 and 27 Aug 2026.
◆ ◆ The Wire takeaway
Your biotech startup focused on obesity treatments gains a clearer path in the US as new FDA approval opens the post-weight loss maintenance market to local fat reduction drugs combined with tirzepatide. Clinical validation now demands accelerating trial recruitment and preparing for competitive positioning.
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2 sources · first reported 26 Aug 2026 · latest 27 Aug 2026
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