Kangpei Announces HREC Approval in Australia for CBL-0302, the Second Global Pivotal Phase 3 Trial of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
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Kangpei has announced that its second global pivotal Phase 3 clinical trial, CBL-0302 (SUPREME-02), evaluating CBL-514 injection for reducing abdominal subcutaneous fat, has received approval from Australia's HREC (Human Research Ethics Committee) on June 18, 2026. The trial will enroll approximately 320 participants across the U.S., Canada, and Australia, using MRI and patient-reported outcomes (PR-AFRS) as primary efficacy endpoints.
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Frequently Asked Questions
- Q: Where is the CBL-514 clinical trial being conducted?
- A: The trial is being conducted across multiple sites in the U.S., Canada, and Australia.
- Q: What are the primary endpoints?
- A: Changes in fat volume measured by MRI and patient-reported PR-AFRS scores.
- Q: How many participants are enrolled?
- A: Approximately 320 subjects are expected to be enrolled.
- Q: What conditions does CBL-514 target?
- A: It targets abdominal fat reduction, moderate to severe cellulite, and Sogen Syndrome.
- Q: What is the next development step?
- A: Following CBL-0302, the long-term follow-up trial CBL-0303 is in progress.