This clinical trial is the second in a series of Phase II studies of ATX-101 in aesthetic applications and is aimed at assessing the safety and effectiveness of ATX-101 as a ‘liposculpting’ agent. The clinical program aims to lead to registration of ATX-101 as an approved prescription drug in the US, Europe and Asia.
The multi-center, randomized, double-blind, placebo-controlled, Phase II trial will enroll approximately 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 UK, Canada and Australia.
Keith Leonard, president and CEO of Kythera, said: “The initiation of this second Phase II trial in the ATX-101 submental fat program is an important milestone for Kythera. It moves us one step closer to meeting consumer and physician demand for a safe, effective, well-studied and approved product for localized fat reduction.”