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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2026

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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

  • 25 Aug 2026 According to Caliway Biopharmaceuticals media release, significant progress has been made on the pivotal Phase 3 clinical trial SUPREME-01 which has received IRB approval in the U.S. and enrollment has now commenced.
  • 25 Aug 2026 According to Caliway Biopharmaceuticals media release, The protocol amendment for the pivotal Phase 3 clinical trial SUPREME-01 has been approved by the North American central Institutional Review Board (IRB) in the US, officially initiating subject enrollment.
  • 25 Aug 2026 Status changed from not yet recruiting to recruiting.

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