EXCLUSIVE: Vivani Medical Initiates First Human Clinical Trial With GLP-1 Implant For Weight Loss In Australia

On Thursday, Vivani Medical Inc. VANI initiated screening and enrollment at two centers in Australia for the first-in-human clinical trial, LIBERATE-1.

The trial investigates the safety, tolerability, and full pharmacokinetic profile of an exenatide implant.

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.

Also Read: EXCLUSIVE: Vivani Medical Reveals Positive Preclinical Liver Fat Results From Miniature GLP-1 Implant For Obesity

The study is the first clinical application of the company’s proprietary NanoPortal drug implant technology.

In September, the Bellberry Human Research Ethics Committee approved, and the Therapeutic Goods Administration in Australia formally acknowledged a first-in-human clinical trial of the company’s miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects.

The trial will enroll participants who will be titrated on weekly semaglutide injections for 8 weeks before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.

Weight changes will be measured. The company anticipates that top-line data will be available in mid-2025.

If available, Vivani intends to utilize research and development incentives and rebates from the Australian government to defray some of the costs from this clinical trial.

Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated in Australia are generally acceptable to the FDA and other regulatory authorities.

Vivani anticipates using relevant clinical data generated in Australia to support regulatory submissions in other geographies, including the U.S.

Vivani’s pipeline also includes NPM-139 (semaglutide implant), which is also under development for chronic weight management in obese and overweight individuals.

Price Action: VANI stock is up 0.83% at $1.22 during the premarket session at last check on Thursday.

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