Vivani Medical announces the approval of its clinical trial for a miniature GLP-1 implant, designed to offer comparable effectiveness to semaglutide, found in Ozempic® and Wegovy®. This implant aims to provide treatment with twice-yearly administration, a significant advantage over existing products.
The clinical trial, LIBERATE-1™, will evaluate the safety, tolerance, and pharmacological effects of the GLP-1 implant in overweight and obese individuals. Participants will receive either Vivani’s implant, weekly exenatide injections or weekly semaglutide injections for nine weeks.
Preclinical studies have shown promising weight loss and liver fat reduction results, indicating the potential of the implant to match the effectiveness of semaglutide. The unique design of the implant targets medication non-adherence, a major challenge for patients, by ensuring consistent drug delivery. This is expected to enhance treatment tolerability.
The trial is planned to commence in Australia later this year, with data anticipated in 2025. Vivani intends to explore incentives and rebates from the Australian government to cover trial expenses partially. Data from this study may contribute to regulatory submissions in other regions, including the United States.
Vivani believes its ultra-long-acting GLP-1 implant platform, NanoPortal™, has the potential to differentiate itself from current treatments, offering the benefits of twice-yearly administration and improved adherence, ultimately enhancing patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
