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Highlights
Skye Bioscience has completed the 26-week treatment phase in its Phase 2a CBeyond™ trial of nimacimab for obesity and overweight.
Enrollment is complete for the 26-week extension study, enabling evaluation of nimacimab as monotherapy and in combination with semaglutide (Wegovy®) for up to 52 weeks.
Topline results from the primary study are expected in late Q3/early Q4 2025, with extension study results anticipated in Q1 2026.
Skye Bioscience, Inc. (Nasdaq:SKYE), a clinical-stage biotechnology company focused on therapeutic innovations in metabolic health, announced that the last patient has finished 26 weeks of treatment in the primary study of its Phase 2a CBeyond™ clinical trial evaluating nimacimab for obesity and overweight. Topline data from this trial are anticipated in late Q3 or early Q4 of 2025.
The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study that aims to assess weight loss, safety, tolerability, and additional metabolic biomarkers in adults with obesity and overweight. The trial’s primary endpoint is focused on evaluating changes in body weight from baseline to 26 weeks, comparing outcomes between participants receiving nimacimab and those receiving placebo.
An exploratory arm of the study is examining the combination of semaglutide (Wegovy®) and nimacimab compared with semaglutide and placebo. This combination arm is designed to determine whether the dual mechanism could enhance weight loss outcomes compared to semaglutide alone.
In addition to the main 26-week study, Skye has completed enrollment for a 26-week extension of the Phase 2a trial. This extension, first announced in July 2025, is designed to generate data from 52 weeks of treatment. The extended evaluation will provide insight into the longer-term effects of nimacimab, whether used as monotherapy or in combination with semaglutide.
Participants who completed 26 weeks in the primary study were eligible to enroll in the extension, allowing for a potential full treatment duration of 52 weeks, followed by a 12-week follow-up period. In this extension, patients in the nimacimab monotherapy group will receive open-label treatment, while participants in the combination arms will continue with blinded administration of either nimacimab or placebo alongside semaglutide.
The company expects to share results from the 52-week extension in Q1 2026. Skye has stated that data from both the primary and extended studies will contribute to understanding the therapeutic potential of nimacimab, a peripherally-restricted CB1 inhibitor antibody, in addressing obesity and related metabolic disorders.
Skye Bioscience’s development approach centers on advancing next-generation molecules that modulate G-protein coupled receptors. The company leverages validated biologic targets with established human proof of mechanism to develop novel therapeutics with the potential for differentiation in clinical and commercial settings.
As the CBeyond™ program progresses, the results from these studies are expected to help define the role of nimacimab in obesity management, including its standalone efficacy and its potential in combination with GLP-1 receptor agonists such as semaglutide.
