The company initiated its LIBERATE-1 trial at two centers in Austrlalia. It will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects.

This study follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes.

Vivani’s implant utilizes the company’s proprietary NanoPortal drug implant technology. Alameda, California-based Vivani designed NanoPortal technology to steadily deliver medication over extended periods of time. The company aims to guarantee correct doses for patients while avoiding potential safety concerns around fluctuating drug release profiles. It can also deliver large hydrophilic molecules, including peptides and proteins. The company believes this enables a broader range of therapeutic applications.