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Vivani Medical announced that it has finished dosing all participants in an early human trial of a tiny implant that slowly releases semaglutide, a drug used for weight loss. This was a Phase 1 study, which mainly checks if the implant can be given safely and whether it behaves in the body the company expects. The announcement is a milestone for the company, but it doesn’t prove the implant works for losing weight in the long run. Semaglutide is the active ingredient in prescription drugs like Ozempic and Wegovy. It’s a lab-made version of a natural hormone your gut makes after you eat, and it tells the brain you’re full and slows how quickly your stomach empties. Right now people take it as a weekly injection or a pill. Vivani’s implant is meant to be a miniature device put under the skin that steadily releases semaglutide over a long time, so patients wouldn’t need frequent injections. The study they completed is a Phase 1 trial, which usually involves a small number of healthy volunteers or people with the condition and looks mainly at safety, tolerability, and how the drug levels behave in the body. The company says all participants were dosed, which means the implants were successfully placed and started releasing the medication. The announcement doesn’t provide details here about how many people were in the trial, how long the implant released drug, or specific safety and blood-level results. So we don’t yet know how effective the implant is for weight loss or how it compares to regular injections. Why this matters is straightforward: many people who could benefit from semaglutide-based therapies find weekly injections inconvenient or simply don’t like needles. An implant that lasts months could make treatment easier to stick with and could expand access for people who struggle with regular dosing. If it’s safe and works the same as injections, it could change how chronic weight management is delivered, especially for people who need long-term therapy and prefer less frequent dosing. There are important caveats. Phase 1 trials are small and not designed to prove that a treatment works for weight loss; they’re first checks on safety and dosage behavior. Implants also carry their own risks, such as infection at the insertion site, device malfunction, or local tissue reaction. We don’t yet know regulatory status, long-term safety, or whether larger trials will confirm both effectiveness and safety compared with the existing injection options. Until larger, controlled studies are published, this news is an early step, not a guarantee of a new approved treatment. Bottom line: Vivani has completed the first human dosing of a long‑acting semaglutide implant, which is an encouraging early step, but more and larger studies are needed to prove it’s safe and effective for weight loss.
Source: The Manila Times