Vivani Medical has announced plans to start the first clinical study of its investigational six-month glucagon-like peptide 1 (GLP-1) implant (exenatide implant) for chronic weight management in Q4 this year.
The company plans to trial the implant in obese or overweight patients with a related comorbidity. Vivani is expecting regulatory clearance to start the LIBERATE-1 study in Australia.
The company previously planned to develop the GLP-1 implant for type 2 diabetes indication but has since re-prioritised to develop the implant as an obesity treatment. Last month, Vivani received clearance from the US Food and Drug Administration (FDA) to study the implant in patients with type 2 diabetes, with plans to start trials in H2 this year. The implant under investigation for obesity is the same as for type 2 diabetes, as per the company.
GLP-1 obesity therapies have been dubbed “wonder drugs” and already generated billions in sales. GlobalData estimates that GLP-1 receptor agonist sales for the type 2 diabetes and obesity markets will reach more than $125bn in 2033.
GlobalData is the parent company of Clinical Trials Arena.
Weight loss therapies including Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide) have been increasing in popularity in recent years. Novo Nordisk’s obesity drugs, Wegovy and Saxenda (liraglutide), generated Dkr41.6bn ($6bn) in combined global sales in 2023, as per the company’s Q4 financials.
Vivani’s LIBERATE-1 trial is expected to enrol 24 participants who will be randomised to receive either the GLP-1 implant, Wegovy, or a weekly exenatide injection Bydureon BCise, over nine weeks. The company expects its implant to produce comparable exenatide exposure levels as Bydureon BCise. The results from the trial are expected in 2025.
“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, PhD, Vivani’s President and Chief Executive Officer.
“Once the target dose is identified, we intend to study an implant at that dose over the full six-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.”
