Caliway Gets FDA IND Nod for Phase 2 CBL-514 Trial of Abdominal Fat Reduction Drug; Shares Down 4%
MT Newswires Live
Yesterday
Caliway Biopharmaceuticals Co Ltd (TPE:6919) has received approval from the U.S. Food and Drug Administration for an investigational new drug application for a second-phase trial of the combination use of CBL-514 and Zepbound to reduce abdominal subcutaneous fat in overweight or obese adults.
The company plans to enroll 120 subjects in the US for Phase 2 of the trial to evaluate the efficacy, safety, and tolerability of the combination use of CBL-514 and tirzepatide, according to a Monday filing to the Taiwan stock exchange.
The company's shares were down nearly 4% in Tuesday's trade.
This study will evaluate abdominal fat volume change measured by MRI as an efficacy endpoint.
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