Vivani Medical, Inc. (VANI) is taking a significant step forward in its quest to revolutionize obesity treatment. The company has announced that the Bellberry Human Research Ethics Committee has given the go-ahead, and the Therapeutic Goods Administration in Australia has formally acknowledged the commencement of a first-in-human clinical trial for its innovative miniature, subdermal GLP-1 (exenatide) implant. This groundbreaking trial marks a pivotal moment for Vivani and the broader field of obesity management.
The trial, aptly named LIBERATE-1, will be a randomized investigation delving into the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in individuals grappling with obesity or being overweight. The trial will enroll participants who will undergo a period of titration on weekly semaglutide injections for eight weeks. This will involve starting at 0.25 mg/week for four weeks followed by an increase to 0.5 mg/week for another four weeks. Following this period, participants will be randomly assigned to one of three groups: those receiving a single administration of Vivani’s exenatide implant (n=8), those continuing with weekly exenatide injections (n=8), and those receiving weekly 1 mg semaglutide injections (n=8). All participants will be monitored for a duration of nine weeks to assess weight changes. The trial is scheduled to initiate later this year with data projection for availability in 2025.
The significance of this trial lies in its potential to address a critical need for innovative solutions to manage obesity. Vivani’s GLP-1 implant promises to offer comparable efficacy to semaglutide, the active ingredient in blockbuster medications like Ozempic and Wegovy, with the added benefit of twice-yearly administration. This could significantly improve patient adherence and convenience compared to existing weekly or monthly injections.
Vivani’s commitment to leveraging research and development incentives and rebates from the Australian government is a testament to the company’s dedication to making its groundbreaking technology accessible. Furthermore, the fact that clinical studies conducted in Australia adhere to International Conference on Harmonization guidelines and generate data readily accepted by the FDA and other regulatory authorities strengthens Vivani’s prospects for expanding its reach beyond Australian borders. The data gathered from this trial is expected to play a crucial role in supporting regulatory submissions in other key markets, including the United States.
This news comes on the heels of Vivani’s earlier announcement regarding preclinical weight loss and liver fat data, further bolstering the potential of its GLP-1 implant. This clinical trial represents a major step toward bringing this innovative treatment option to patients in need. If successful, Vivani’s GLP-1 implant could potentially reshape the landscape of obesity management, offering a convenient and effective alternative to current treatment options.
