Vivani Medical has received approval from the Bellberry Human Research Ethics Committee (HREC) for the initiation of a first-in-human clinical trial in Australia for its glucagon-like peptide 1 (GLP-1) implant, designed for obese and overweight individuals.
The Therapeutic Goods Administration (TGA) has also formally acknowledged the trial.
Named LIBERATE-1, the trial will assess the tolerability, safety and pharmacokinetic profile of the company's exenatide implant. This marks the first clinical use of Vivani's NanoPortal drug implant technology.
The study will randomise participants to receive either Vivani's exenatide implant, weekly exenatide injections or semaglutide injections after an initial eight-week titration period with semaglutide.
Participants in the trial will undergo an eight-week titration with semaglutide injections before being randomised into one of three treatment arms.
Each group will comprise eight subjects, and the trial aims to measure changes in weight over a nine-week treatment period. The study's commencement is slated for later this year, with results expected in 2025.
Vivani president and CEO Dr Adam Mendelsohn said: “Preclinical weight loss and liver fat data announced earlier this year supports the potential for our GLP-1 implant to provide comparable efficacy to semaglutide, the active ingredient in blockbuster products Ozempic and Wegovy, but with the significant benefit of twice-yearly administration.
“We remain confident that our emerging portfolio of miniature, ultra long-acting, GLP-1 implants has the potential to be highly differentiated from the injectable and oral products in the market and development.”
Vivani plans to leverage research and development incentives from the Australian government to offset some of the trial costs.
The company noted that clinical data from Australia is generally acceptable to regulatory authorities globally, including the US Food and Drug Administration, which will aid in regulatory submissions across various regions.
In July this year, the company announced plans to commence the first clinical study of the six-month GLP-1 implant for chronic weight management.
