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Vivani Medical Receives Regulatory Approval for the Initiation of SLIM-1, a Phase 1 Clinical Trial of NPM-139 Semaglutide Implant in Obesity and Chronic Weight Management

  • Vivani Medical received HREC approval from Bellberry in Australia to initiate the SLIM-1 Phase 1 clinical trial.
  • The trial evaluates NPM-139, a semaglutide implant, with near-term initiation expected in mid-2026.
  • SLIM-1 is an open-label, randomized, active comparator-controlled study assessing safety, tolerability, & pharmacokinetics in obese or overweight subjects.
  • The trial design compares low-dose NPM-139 against Wegovy (0.25 mg/week) over a four-week duration with 10 subjects per group.
  • CEO Adam Mendelsohn noted the trial builds on the success of the 2025 NPM-119 (exenatide implant) Phase 1 trial in Australia.
  • Vivani is preparing for SLIM-2, a dose-ranging efficacy trial, pending successful results from SLIM-1.
  • Vivani utilizes its NanoPortal platform to develop miniature, ultra long-acting GLP-1 implants for metabolic diseases like obesity & type 2 diabetes.