Caliway Biopharmaceuticals said the U.S. Food and Drug Administration has approved a Phase 2 clinical trial combining its experimental drug CBL-514 with Eli Lilly’s tirzepatide.
The randomized, single-blind, placebo-controlled study will enroll 120 overweight or obese adults in the United States to assess subcutaneous abdominal fat reduction using MRI. Primary endpoints include volumetric changes, efficacy, safety, and tolerability. Caliway plans to present related data at the 62nd Annual Meeting of the European Association for the Study of Diabetes on September 30, 2026.
Separately, the company received approval from the North American Central Institutional Review Board to begin recruitment for its pivotal Phase 3 SUPREME-01 trial evaluating CBL-514 for reducing large-area abdominal fat. Caliway said more than 544 participants have taken part in prior CBL-514 trials, with all primary and key secondary endpoints met across 10 completed studies.
CBL-514 is a small-molecule injection designed to induce adipocyte apoptosis to reduce localized subcutaneous fat. W. Timothy Garvey is scheduled to present findings showing concurrent reductions in visceral adipose tissue volume and subcutaneous fat in the upcoming meeting.
