Skye Bioscience has reached a key milestone in its CBeyond Phase 2a clinical trial, with the last patient completing 26 weeks of treatment in the main study.

The trial is evaluating nimacimab, the company’s peripherally restricted CB1 inhibitor antibody, as a potential treatment for obesity and overweight. Topline data are expected in late Q3 or early Q4 2025.

The randomized, double-blind, placebo-controlled study was launched 12 months ago to assess weight loss, safety, tolerability, and other metabolic biomarkers. Its primary endpoint compares weight change from baseline to 26 weeks between nimacimab and placebo. An exploratory arm is testing the combination of semaglutide (Wegovy) with nimacimab against semaglutide plus placebo.

Puneet Arora, chief medical officer at Skye, said: “We launched CBeyond to establish proof-of-concept for nimacimab and are pleased the final patient has completed treatment for the primary endpoint. We thank the patients, investigators, coordinators, and partners whose commitment enabled the rapid conduct of this important study.”

Arora added: “There is growing recognition that GLP-1 weight loss drugs cannot meet all patients’ needs. Many induce tolerability issues that compromise or prevent long-term benefit. We don’t believe there is another new mechanism with as much evidence of potential as CB1 inhibition — and specifically, peripheral CB1 inhibition driven by an antibody. We look forward to reporting topline results from this first stage and advancing our assessment of nimacimab as a potential new therapeutic option for obesity and overweight.”

Alongside the 26-week study, Skye has completed enrollment for the 26-week extension announced in July 2025. This extension is designed to provide 52 weeks of treatment data for nimacimab as monotherapy or in combination with semaglutide, followed by a 12-week post-treatment period. Patients in the monotherapy arm will receive open-label nimacimab, while those in the combination arms will continue with blinded treatment alongside semaglutide. Skye expects to share results from the extension in Q1 2026.

The company said the extension will offer valuable longer-term insight into the effects of CB1 inhibition in obesity, complementing shorter-term findings from the 26-week study.