Introduction and Objective: Efsubaglutide alfa (Suba) is a novel GLP-1RA. ENLIGHT is a seamless Phase 2b/3 program; the Phase 2b stage evaluated Suba regimens to inform dose selection for the subsequent Phase 3 study.Methods: This double-blind, placebo (PBO)-controlled trial (NCT06921486) randomized participants to Suba 5, 10, or 20 mg once weekly (QW), 20 mg once every 2 weeks (Q2W), or PBO. Treatment started at 1 mg with individualized dose escalation every 2 weeks to reach target doses and continued for a total of 18 weeks. The primary endpoint was percent change in body weight (BW) at end of treatment. Secondary endpoints included BW change (kg), the proportion achieving ≥5% weight loss, and waist circumference (WC). Safety endpoints included TEAEs, vital signs, 12-lead ECG, and laboratory tests.Results: BW change (%) was −3.61 with PBO and −7.95, −9.99, −10.58, and −9.70 with Suba 5, 10, and 20 mg QW, and 20 mg Q2W; BW change (kg) was −2.88 vs −6.73, −8.59, −9.22, and −8.48. The proportions achieving ≥5% weight loss were 26.8% with PBO and 75.6%, 78.0%, 81.6%, and 73.7% with Suba regimens. WC decreased by −4.35 cm with PBO vs −6.88 to −8.94 cm with Suba. Efficacy was generally dose dependent (20mg Q2W comparable with 10mg QW) (Fig. 1). TEAEs were mostly mild-to-moderate gastrointestinal, with no premature discontinuations or drug-related SAEs.Conclusion: ENLIGHT regimens (QW and Q2W) produced clinically meaningful weight loss with a favorable safety profile, supporting progression to the Phase 3 stage.
Y. Bao: None. F. Gao: None. Z. Li: None. Y. Yang: None. Y. Wang: None. Z. Cheng: None. L. Chen: Research Support; Current; AstraZeneca, Lilly, Gan & Lee Pharmaceuticals, Novo Nordisk, Sanofi. J. Xiao: None. Y. Wang: None. B. Liu: None. L. Yan: None. Y. Lu: None. C. Yang: None. H. Chen: None. J. Zhou: None. W. Jia: None. Q. Wang: Board Member; Current; Innogen Pharmaceuticals Technology Co., Ltd.
Innogen Pharmaceutical Co. Ltd.
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