Caliway Biopharmaceuticals has received clearance from the US FDA to initiate SUPREME-01 (CBL-0301)—a pivotal global Phase 3 trial of CBL-514, the first investigational drug aimed at large-area localized fat reduction. This FDA nod marks a key regulatory milestone for Caliway’s global development strategy.

Set to begin in Q3 2025, the study will recruit 300 participants across 29 sites in the US and Canada, randomized to receive either CBL-514 or placebo. SUPREME-01 is a randomized, double-blind, placebo-controlled trial evaluating reduction in abdominal fat via MRI and Patient-Reported Abdominal Fat Rating Scale (PR-AFRS), both validated in earlier Phase 2b studies.

CBL-514 is the first 505(b)(1) injectable drug to enter Phase 3 for the "Reduction of Abdominal Subcutaneous Fat"—a potential shift beyond conventional aesthetic treatments toward therapeutic fat reduction.

Topline results are expected between Q4 2026 and Q1 2027. Meanwhile, Caliway plans to submit a second global Phase 3 trial, SUPREME-02, and initiate a Phase 2 study of CBL-514 combined with Tirzepatide for long-term weight management.

CBL-514, a small-molecule drug that induces adipocyte apoptosis, has shown no systemic side effects in 10 completed trials involving 520 subjects. Additional studies are underway for cellulite, fat rebound, and rare fat-related disorders.