Vivani Plans 2027 IND Filing for Semaglutide Implant Study After Dosing 20 Participants
Key Facts
Vivani Medical said on Nov. 11 that preliminary results from the SLIM-1 trial would be announced during the same week, but its third-quarter results statement did not include the trial findings. The study is testing the NPM-139 implant, a subcutaneous semaglutide implant, in participants who are overweight or have obesity. The company designed it as a four-week, open-label study focused on safety, tolerability and pharmacokinetics. Each of its two arms includes 10 participants: one receives a low dose of the implant and the other weekly Wegovy injections at the starting dose. The expected results therefore remain an early step in evaluating the implant and cannot by themselves establish its effectiveness for weight loss or superiority to the comparator treatment.
Vivani plans to prepare and submit an investigational new drug (IND) application in 2027 to support the start of a proposed Phase 2 dose-finding study. The company said on Nov. 11 that preliminary SLIM-1 data would be released during the same week, after previously forecasting in an earlier statement that it would announce them in November 2026. In August, it said it had completed enrollment of all 20 participants in Australia and administered their initial doses. This places the current study within a development program moving from early testing of safety and drug exposure to a proposed dose-evaluation stage. The Phase 2 study remains proposed, while the announced timeline concerns preparation and submission of the IND application.
The company describes NPM-139 as a subcutaneous mini-implant designed to deliver semaglutide continuously over a period of between six and twelve months. This approach differs from the weekly Wegovy injections used in the comparator group at the starting dose of 0.25 mg per week. SLIM-1 is intended to study safety, tolerability and pharmacokinetics over four weeks, while the targeted delivery period describes the implant’s design. Vivani announced in 2025 a preclinical study that showed weight loss of about 20% compared with placebo, lasting more than six months at the time of the announcement. Those earlier data came from an animal study and are not human results from SLIM-1.
In July, Vivani announced a non-exclusive agreement allowing Novo Nordisk to evaluate NPM-139 and the company’s NanoPortal technology, with no exclusivity terms tied to either. The agreement is a separate track from the clinical trial and does not change the fact that SLIM-1 is an early human evaluation of the implant. On financing, the company reported cash, cash equivalents and restricted cash of $15.5 million on Sept. 30, 2026, down from $20.8 million on June 30. In the market, VANI shares closed at $1.13 in the Nov. 11 session, according to EL7 data. These figures place the announced 2027 development plan alongside the company’s available liquidity and the share price in the latest session before the news date.