Vivani Medical has reported positive topline findings from its Phase I SLIM-1 trial evaluating NPM-139, a subdermal semaglutide implant for chronic weight management in obese or overweight patients.
The open-label, active-controlled trial (NCT07430059) assessed the safety, tolerability, and pharmacokinetics of low-dose NPM-139, an implanted glucagon-like peptide-1 receptor agonist (GLP-1RA), against weekly low-dose Wegovy injections over a four-week treatment period.
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Conducted at a single study centre in Australia, the trial evaluated 20 otherwise healthy overweight or obese patients, with all subdermal implant insertions and removals completed without complications.
Patients receiving NPM-139 achieved 0.79% weight loss with zero treatment-related adverse events, whilst five Wegovy recipients experienced gastrointestinal events, and no serious adverse events occurred.
Pharmacokinetic data showed that NPM-139 did not produce rapid increases in drug exposure, reaching peak concentrations at approximately 16 days, compared with around 2.4 days in the Wegovy (semaglutide) group.
Vivani Medical CEO Adam Mendelsohn said: “The positive topline data from our SLIM-1 Phase I trial marks a critical milestone for Vivani, demonstrating encouraging clinical translation from preclinical models to humans, an encouraging delivery profile, and a strong tolerability profile. Real-world data show a staggering level of GLP-1RA therapy drop-off.
“By some estimates, more than 50% of GLP-1RA users discontinue their therapy within a single year, with gastrointestinal side effects driving much of this attrition. The long-term health outcomes and related pharmacoeconomic value that have been associated with GLP-1RA therapy are only realised when patients remain on treatment for durations significantly longer than one year.
“The absence of rapid drug exposure increases from the NPM-139 group is both desirable and reassuring because rapid increases in drug concentrations have been associated with tolerability issues with other GLP-1RA therapies.
“The strong NPM-139 safety and tolerability profile in SLIM-1 reinforces our belief that NPM-139 may directly address a major reason for attrition in GLP-1RA therapies, while simultaneously improving medication adherence and convenience for patients.”
Vivani expects to start a Phase II dose-ranging trial for weight maintenance in 2027. The company is also exploring clinical development in GLP-1RA-naïve patients.
Under a non-exclusive agreement announced in July 2026, Vivani continues to support Novo in evaluating NPM-139 and its NanoPortal technology.
