India, Aug. 26 -- Caliway Biopharmaceuticals (6919.TW) announced that the U.S. FDA has cleared the Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating its CBL-514 in combination with tirzepatide for abdominal subcutaneous fat reduction in overweight or obese adults.
The randomized, single-blind, placebo-controlled study is expected to enroll 120 subjects in the U.S. and will use MRI to evaluate changes in abdominal subcutaneous fat volume.
The trial will also assess the combination's safety, tolerability and exploratory measures, including body weight, visceral fat and lean body mass.
CBL-514 is a first-in-class small-molecule injection designed to selectively induce adipocyte apoptosis, reducing the number of...