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A Phase 3, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat.

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Trial Profile

A Phase 3, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat.

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2025

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At a glance

  • Drugs CBL-514 (Primary)
  • Indications Adiposis dolorosa; Cellulite; Obesity; Subcutaneous fat disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms SUPREME-01
  • Sponsors Caliway Biopharmaceuticals

Most Recent Events

  • 28 Jul 2025 According to Caliway Biopharmaceuticals media release, The topline results from SUPREME-01 are expected between Q4 2026 and Q1 2027.
  • 28 Jul 2025 According to Caliway Biopharmaceuticals media release, CBL-514 is the first 505(b)(1) investigational drug which has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in Q3 2025 at 29 clinical sites across the United States and Canada.
  • 12 Mar 2025 According to Caliway Biopharmaceuticals media release, subject recruitment expected in Q3 2025.

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