Device implant to challenge weekly obesity injections in first Australian trial

Days following the announcement of the spin-off of its neurostimulation business to sharpen its focus on weight loss, obesity and diabetes implants, Vivani Medical has marked a significant milestone by implanting the first patient in Australia with its NPM-115 device.

The procedure is part of LIBERATE-1, a first-in-human clinical trial evaluating the implant’s potential in obese or overweight individuals. Vivani’s other implant, NPM-119, is being developed to address type 2 diabetes.

NPM-115 is a miniature sub-dermal implant designed to deliver exenatide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), over a six-month period. Unlike traditional GLP-1RA therapies, which require frequent injections, the implant aims to improve medication adherence by offering a sustained-release alternative.

Vivani confirmed that LIBERATE-1 is now fully enrolled. The study will assess the implant’s safety, tolerability, and full pharmacokinetic profile. Participants will first receive two months of Novo Nordisk’s GLP-1RA injection, Wegovy (semaglutide), before being assigned one of three treatments: Vivani’s implant, weekly injections of AstraZeneca’s Bydureon BCise, or continued weekly Wegovy doses. The study will track weight changes over nine weeks, with top-line data expected by mid-2025.

GLP-1RAs have become a dominant force in the pharmaceutical market. Wegovy is projected to generate $19.4 billion in global sales by 2030, while Eli Lilly’s rival therapy, Mounjaro (tirzepatide), which demonstrated superior efficacy in the SURMOUNT-5 trial, is forecasted to reach $25.2 billion in the same timeframe.

Despite their success, GLP-1RA treatments face a hurdle – patient adherence. One‐year treatment discontinuation rates in clinical trials are 17 – 50% for medications currently approved for long term weight management, but persistence with treatment is much lower (< 10%) in real‐world studies, according to a recent Australian review.

Vivani believes its long-acting implant could provide a much-needed alternative, addressing adherence challenges while reducing the burden of frequent injections.

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