EXCLUSIVE: Vivani Medical Outlines Plans To Kickstart First Clinical Study For Miniature GLP-1 Obesity Implant Program This Year
EXCLUSIVE: Vivani Medical Outlines Plans To Kickstart First Clinical Study For Miniature GLP-1 Obesity Implant Program This Year
Vivani Medical Inc. (NASDAQ:VANI) expects to initiate the first clinical study for the NPM-115 program in Australia in the fourth quarter of 2024.
Vivani Medical公司（納斯達克：VANI）預計將在2024年第四季度在澳洲啓動NPm-115方案的首項臨床研究。
The NPM-115 clinical program will evaluate the investigational 6-month GLP-1 implant for chronic weight management in patients who are either obese or overweight with a related comorbidity.
NPm-115臨床方案將評估調查性爲期6個月的GLP-1植入物，以治療伴有相關合並症的超重或肥胖患者。
LIBERATE-1 will be a randomized investigation of the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight patients.
LIBERATE-1將是一個隨機研究，旨在評估緩釋劑型exenatide納米門戶植入物在超重或肥胖患者中的安全性、可耐受性和藥代動力學特徵。
Related: Vivani Medical Highlights Weight Loss Data For GLP-1 Implant Supporting Potential Veterinary Use.
相關文章：Vivani Medical強調GLP-1植入物的減重數據，支持其潛在獸醫用途。
The study will enroll patients who will be titrated on weekly semaglutide injections for eight weeks (0.25 mg/week for four weeks followed by 0.5 mg/week for four weeks) before being randomized to receive a single administration of Vivani's exenatide implant (n=8), weekly exenatide injections Bydureon BCise (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.
該研究招募患者，這些患者將在8周內進行每週一次的semaglutide注射，其中前4周注射0.25 mg/周，之後的4周注射0.5 mg/周，然後隨機分組接受單次Vivani的exenatide植入物( n=8 )，每週一次的exenatide注射Bydureon BCise(n=8)，或每週一次的1 mg semaglutide注射(n=8)，爲期9周的治療。
Semaglutide is an active ingredient used in Novo Nordisk A/S's (NYSE:NVO) Wegovy and Ozempic.
Semaglutide是被用於諾和諾德（紐交所：NVO）Wegovy和Ozempic的一種活性成分。
The exenatide implant used in LIBERATE-1 is expected to produce exenatide exposure levels comparable to those of Bydureon BCise.
在LIBERATE-1中使用的exenatide植入物預計將產生與Bydureon BCise相當的exenatide暴露水平。
Weight changes will be measured. The trial is expected to initiate later this year, and data are projected to be available in 2025.
將測量體重變化。該試驗預計將於今年晚些時候啓動，數據預計將在2025年公佈。
In February, Vivani announced preclinical weight loss data from its exenatide implant, comparable to semaglutide injections, supporting its NPM-115 development program and a strategic shift to prioritize its obesity portfolio.
今年2月，Vivani宣佈了其exenatide植入物的臨床前減重數據，相當於semaglutide注射，支持其NPm-115開發計劃和重點轉向肥胖領域的戰略轉變。
In June, the FDA cleared Vivani's Investigational New Drug for its exenatide implant to be studied in patients with type 2 diabetes.
今年6月，FDA已批准Vivani的新型藥物調查（IND）用於研究患有2型糖尿病的患者的exenatide植入物。
The company previously announced an intention to initiate the first study in the NPM-119 program in the second half of this year.
該公司此前宣佈，計劃在今年下半年啓動NPm-119計劃的第一項研究。
As a result of reprioritizing the focus of its GLP-1 implants on the treatment of obesity and chronic weight management, the company plans to pursue the NPM-115 study first.
由於將GLP-1植入物的重點轉向肥胖和慢性體重管理的治療，公司計劃首先開展NPm-115研究。
Price Action: VANI shares closed at $1.25 on Wednesday.
價格走勢：VANI股票於週三收於1.25美元。
- EXCLUSIVE: GLP-1 Weight-Loss Drugs Could Become A Trillion-Dollar Market, Predicts Tema ETFs CEO.
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