Vivani Medical Receives HREC Approval to Enroll 20 in Phase 1 NPM-139 Trial
VANI•Vivani Medical secured approval from the Bellberry HREC in Australia to initiate SLIM-1, a Phase 1 trial of its NPM-139 semaglutide implant in obese or overweight subjects. The open-label study will enroll 20 participants, comparing low-dose NPM-139 to Wegovy over four weeks to assess safety, tolerability and pharmacokinetics.
1. Regulatory Approval for SLIM-1
The Bellberry human research ethics committee granted approval for SLIM-1 in Australia, enabling Vivani to initiate a Phase 1 trial of its NPM-139 semaglutide implant. The approval clears the way for mid-2026 initiation of the open-label study evaluating safety, tolerability and pharmacokinetics.
2. SLIM-1 Trial Design
SLIM-1 is an open-label, randomized, active comparator-controlled trial enrolling 20 obese or overweight subjects, with 10 participants receiving a low-dose NPM-139 implant and 10 on Wegovy (0.25 mg/week). The four-week study will measure pharmacokinetics, safety, tolerability and preliminary weight loss.
3. Plans for SLIM-2
Vivani is preparing SLIM-2, a dose-ranging, efficacy-oriented trial of NPM-139 pending SLIM-1 results, aiming to accelerate clinical development. Successful SLIM-1 outcomes would support rapid progression into larger efficacy studies.
4. NanoPortal Platform and Market Potential
Leveraging its NanoPortal platform, Vivani develops long-acting GLP-1 implants to improve adherence and patient tolerance compared with daily or weekly administrations. The company targets obesity and type 2 diabetes markets, where non-adherence can affect approximately 50% of patients on oral therapies.
