EXCLUSIVE: Vivani Medical Announces First Implant In Early-Stage Human Study Of GLP-1 Implant For Obesity

On Thursday, Vivani Medical, Inc. VANI announced the administration of its first GLP-1 (exenatide, NPM-115) implant in the LIBERATE-1 trial in Australia.

Vivani's lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals.

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The company also announced full enrollment in the LIBERATE-1 study, which was achieved four weeks after the first subject enrolled, and reaffirmed that top-line results should be available in mid-2025.

In December, Vivani Medical initiated screening and enrollment at two centers in Australia for the first-in-human LIBERATE-1 trial.

The LIBERATE-1 study is exploring the full pharmacokinetic profile of NPM-115, which has demonstrated consistently smooth and minimally fluctuating drug release in vitro and in animal models.

LIBERATE-1 is a Phase 1, first-in-human study of a miniature, ultra-long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability, and full pharmacokinetic profile in obese or overweight subjects.

The trial will enroll participants who are intended to be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani's exenatide implant (NPM-115, n=8), weekly exenatide injections (Bydureon BCise, n=8), or weekly 1 mg semaglutide injections (Wegovy, n=8) for 9-week treatment duration.

Vivani also expects these results to support the potential application of a GLP-1 (exenatide) implant for type 2 diabetes and other diseases for which GLP-1 treatment has demonstrated or will demonstrate clinical benefit.

AstraZeneca Plc's AZN Bydureon BCise (exenatide 2 mg prolonged-release suspension for injection) is indicated for type-2 diabetes.

Novo Nordisk A/S' NVO semaglutide is approved as Ozempic and Wegovy for diabetes and weight loss, respectively.

Price Action: VANI stock is down 2.74% at $1.01 during the premarket session at the last check Thursday.

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