Vivani Medical Advances Long-Acting Semaglutide Implant Toward Phase 2 Trial in 2027
Vandana Singh 1 hour ago
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Vivani Medical reports Phase 1 results for its NPM-139 implant, matching Wegovy weight loss without treatment-related side effects.
Vivani Medical Inc. (NASDAQ:VANI) stock soared on Thursday after reporting positive topline results from its Phase 1 SLIM-1 clinical trial, showing that its experimental semaglutide implant matched Wegovy in weight loss without causing treatment-related side effects.
The clinical-stage biopharmaceutical company develops miniature, ultra-long-acting drug implants using its proprietary NanoPortal technology.
Vivani designed the subdermal implant, called NPM-139, for once- or twice-yearly administration to support chronic weight management in obese or overweight adults.
SLIM-1 Trial Design And Weight Loss Results
Researchers conducted the four-week, open-label, active-controlled SLIM-1 study at a single center in Australia.
The trial enrolled 20 otherwise healthy overweight or obese participants to evaluate safety, tolerability, pharmacokinetics, and weight changes.
Ten participants received a low dose of NPM-139, while a 10-person control group received Wegovy’s weekly 0.25 mg starting injection. Clinicians completed all implant insertions and removals quickly and without complications.
By the end of the four-week period, both groups achieved comparable weight reductions.
Participants in the NPM-139 group lost 0.79% of their body weight, while those in the Wegovy control group lost 0.82%.
Strong Safety And Drug Release Profile
NPM-139 demonstrated a favorable safety and tolerability profile compared to the weekly injection. Zero of the 10 NPM-139 participants experienced treatment-related adverse events.
In contrast, five of the 10 Wegovy participants developed treatment-related gastrointestinal side effects consistent with existing GLP-1 medications.
Investigators recorded no serious adverse events across the entire study.
The implant also delivered a steady pharmacokinetic profile without sudden spikes in drug exposure.
A single NPM-139 administration reached peak drug levels in approximately 16 days, whereas the Wegovy group hit maximum levels in about 2.4 days. Overall semaglutide delivery aligned closely with earlier preclinical findings.
Path To Phase 2 And Novo Nordisk Collaboration
Following these SLIM-1 outcomes, Vivani plans to advance NPM-139 into a Phase 2 dose-ranging weight maintenance trial in 2027.
The company will also evaluate developing the implant for GLP-1-naive patients.
Additionally, Vivani continues supporting Novo Nordisk A/S (NYSE:NVO) as it assesses NPM-139 and the NanoPortal platform under their non-exclusive July 2026 agreement.
VANI Price Action: Vivani Medical shares were down 17.87% at $0.92 at the time of publication on Thursday. The stock is trading near its 52-week low of $0.92, according to Benzinga Pro data.
Photo via Shutterstock
