The US Food and Drug Administration (FDA) has cleared Caliway Biopharmaceuticals’ pivotal Phase III trial, SUPREME-01 (CBL-0301), of its investigational drug CBL-514, aimed at large-area localised fat minimisation.
Recruitment for this double-blind, global, randomised, placebo-controlled trial is set to commence in the third quarter of this year at 29 Canadian and US clinical sites, with plans to randomise 300 subjects and administer either the drug or a placebo.
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The trial’s primary estimand is stated to be a multicomponent responder endpoint, which includes abdominal fat volume change measured by magnetic resonance imaging (MRI) and fat level change evaluated by the patient-reported abdominal fat rating scale (PR-AFRS).
SUPREME-01’s top-line outcomes are anticipated between the fourth quarter of 2026 and the first quarter of 2027.
The company has also finalised the clinical trial application (CTA) submission for this study to Health Canada and is gearing up for the submission of the second worldwide pivotal Phase III trial, SUPREME-02 (CBL-0302), in Canada, the US, and Australia later in 2025.
In a move to expand the therapeutic applications of CBL-514, Caliway intends to submit a Phase II investigational new drug (IND) application to the FDA in the fourth quarter of 2025.
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By GlobalDataThis application will propose combining CBL-514 with Tirzepatide, a glucagon-like peptide-1 (GLP-1) receptor agonist used for obesity treatment, for weight loss maintenance.
CBL-514 claims to be the world’s first injectable lipolysis drug designed to induce adipocyte apoptosis for decreasing subcutaneous fat in targeted locations with no cause of systemic side effects on the central nervous, respiratory, or cardiovascular systems.
Caliway is exploring several indications for the drug, which include moderate-to-severe cellulite, non-surgical fat reduction, and weight management to minimise post-weight-loss fat rebound.
Last year, the company announced that a Phase II trial of CBL-514 injection lipolysis therapy met all primary and secondary efficacy goals.
