Caliway Advances Obesity Pipeline with FDA Clearance and Phase 3 Trial

The new Phase 2 study, designated CBL-0201WR, targets the growing clinical need for post-treatment maintenance. As GLP-1 drugs often lead to weight regain after discontinuation, researchers hope the combination with CBL-514—which triggers adipocyte apoptosis to permanently reduce fat cells—will offer a more durable solution. The randomized, single-blind trial will monitor 120 subjects, using MRI imaging to track changes in subcutaneous and visceral fat volumes.

Meanwhile, the SUPREME-01 study represents a major milestone in the company’s effort to secure the world's first non-surgical drug approval for large-area abdominal fat reduction. If successful, the treatment aims to achieve a two-grade improvement on the Abdominal Fat Rating Scale. Beyond these clinical developments, Caliway has been invited to present research at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Italy. On September 30, 2026, Dr. W. Timothy Garvey will share data highlighting how CBL-514 reduces visceral adipose tissue, further validating the small-molecule therapy's potential in metabolic health.