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The Australian LIBERATE-1 study will evaluate Vivani’s exenatide NanoPortal implant in obese or overweight patients.
July 11, 2024
By: Sam Brusco
Vivani Medical announced that it plans to begin the first clinical study of its investigational six-month GLP-1 implant for chronic weight management for patients who are obese or overweight with a related comorbidity.
The company aims to begin the first clinical study in the NPM-115 program in Q4 of 2024 in Australia, with data available in 2025.
The study, dubbed LIBERATE-1, will investigate the safety, tolerability, and pharmacokinetic profile of Vivani’s exenatide NanoPortal implant in obese or overweight patients. It will enroll subjects who will be given weekly Wegovy injections for eight weeks before being randomized to get a single administration of the exenatide implant, weekly exenatide injections or weekly 1 mg semaglutide injections for a nine-week treatment duration.
Vivani expects the exenatide implant used in LIBERATE-1 to produce comparable exeatide exposure as Bydureon BCise. Weight changes will be measured, as well.
In February, the company revealed positive preclinical weight loss data from the exenatide implant in support of the NPM-115 development program that was comparable to semaglutide injections—specifically, the active ingredient in Ozempic/Wegovy. In June, the FDA cleared its Investigational New Drug for the exenatide implant to be studied in type 2 diabetes patients to support the NPM-119 development program.
“The results of LIBERATE-1 may support initiation of a subsequent clinical study, pending regulatory clearance, to explore higher and potentially more effective doses of our exenatide implant on weight and tolerability in obese or overweight patients,” said Adam Mendelsohn, Ph.D., Vivani’s president and CEO. “Once the target dose is identified, we intend to study an implant at that dose over the full 6-month duration, over which our implant has already demonstrated encouraging results in preclinical animal models. Additionally, we believe the results of LIBERATE-1 may provide clinical validation of our NanoPortal drug delivery technology to support a broader application of the technology in the treatment of chronic diseases.”
Check this out: Can Medtech and GLP-1s Peacefully Co-Exist?
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