Introduction and Objective: The CBeyond trial is an ongoing Phase 2a study evaluating nimacimab, a peripherally restricted anti-CB1R inverse agonist mAb, on weight loss. Nimacimab monotherapy, (sc 200 mg QW), is compared to placebo and nimacimab plus semaglutide to semaglutide alone over 26 weeks of treatment, followed by 12 weeks of follow-up off therapy or 26 week treatment extensionMethods: 136 participants with overweight and obesity were enrolled in the study in a randomized, blinded manner. 99 subjects completed 26 weeks of treatment. 24 subjects on monotherapy (nimacimab or placebo) enrolled in the 26-week extension on open-label nimacimab sc 300 mg QW, 19 combination subjects enrolled in the extension, continuing blinded treatment. The remaining subjects were followed for 12 weeks off therapyResults: In the 12-week off-therapy follow-up, 11 participants previously on combination therapy regained 17.6% (2.4 kg) of weight lost during the study, compared to 11 participants previously on semaglutide that regained 36.8% (2.8 kg). Participants on semaglutide alone who enrolled in the extension had >85% greater weight loss after 26 weeks compared to those who went off therapy (13.9% vs 7.5%), representing a very high responder subset. Following the 26-week extension treatment (52 weeks total), combination participants lost 22.7% (8.3% additional) and patients on semaglutide alone lost 19.7% (5.8% additional) body weightConclusion: Nimacimab in combination with semaglutide, results in durable weight loss after discontinuation of therapy, compared to semaglutide alone. Following 52 weeks of therapy, weight loss with the combination remains greater than semaglutide alone, even in comparison with a high responder subset of semaglutide treated participants. These findings validate the effectiveness of the combination therapy for weight loss seen after 26 weeks, despite a sub optimal dose of nimacimab, and suggest a more durable weight loss after therapy is discontinued
P.S. Arora: Employee; Current; Skye Bioscience. Employee; Ended; Lassen Therapeutics. T.T. Diep: Employee; Current; Skye Bioscience, Inc. J. Kennedy: Employee; Current; Skye Bioscience. M. Guida: Employee; Current; Skye Bioscience. S.A. Morales: Employee; Current; Skye Bioscience. R.L. Ferrini: None. C. Twitty: None.
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