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Skye Bioscience Launches Phase 2 CBeyond Clinical Trial of its Differentiated CB1 Inhibitor, Nimacimab, in Patients with Obesity. Skye Bioscience (Nasdaq: SKYE) has launched a Phase 2 clinical trial, CBeyond™, to evaluate its peripheral CB1 inhibitor, nimacimab, for weight loss in patients with obesity.
The study will assess nimacimab's efficacy as a monotherapy and in combination with a GLP-1 receptor agonist (Wegovy®). Key aspects of the trial include:
- 120 patients across four treatment groups
- 26-week treatment period with 13-week follow-up
- Primary endpoint: weight loss comparison between nimacimab and placebo
- Secondary endpoints: safety, tolerability, and body composition changes
- Exploratory endpoints: metabolic parameters and sleep quality assessment
Skye aims to report interim data in Q2 2025 and final data in Q4 2025. The company believes nimacimab's unique biologic approach may offer improved safety and efficacy compared to small molecule CB1 inhibitors.
- 120 patients across four treatment groups
- 26-week treatment period with 13-week follow-up
- Primary endpoint: weight loss comparison between nimacimab and placebo
- Secondary endpoints: safety, tolerability, and body composition changes
- Exploratory endpoints: metabolic parameters and sleep quality assessment
Skye aims to report interim data in Q2 2025 and final data in Q4 2025. The company believes nimacimab's unique biologic approach may offer improved safety and efficacy compared to small molecule CB1 inhibitors.
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