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Phase II trial underway for submental fat-reduction agent

Article-Phase II trial underway for submental fat-reduction agent

Calabasas, Calif. — Kythera Biopharmaceuticals, based here, recently announced the initiation of a second Phase II clinical trial on its ATX-101 product for the reduction of submental fatty deposits, reports news source Medical News Today.

This clinical trial, the second in a series of Phase II studies of ATX-101 in aesthetic applications, is aimed at assessing the safety and effectiveness of ATX-101 as a liposculpting agent. Kythera officials say the goal of the trial is to get the product registered as an approved prescription drug in the United States, Europe and Asia.

The trial will enroll about 60 patients to assess safety, tolerability and efficacy across two dosing paradigms of ATX-101 in reducing small volumes of submental fat. The study will assess multiple physician- and patient-measured endpoints and is being conducted at centers in the United Kingdom, Canada and Australia.

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