Tafolecimab in Chinese patients with non-familial hypercholesterolemia (CREDIT-1): a 48-week randomized, double-blind, placebo-controlled phase 3 trial.
Abstract | Background: Methods: Non-FH patients at high or very-high cardiovascular risk with screening low-density lipoprotein cholesterol ( LDL-C) level ≥1.8 mmol/L or non-FH patients with screening LDL-C level ≥3.4 mmol/L and on stable lipid-lowering therapy for at least 4 weeks, were randomized in a 2:2:1:1 ratio to receive subcutaneous tafolecimab 450 mg Q4W, tafolecimab 600 mg Q6W, placebo 450 mg Q4W, or placebo 600 mg Q6W, respectively, in the 48-week double-blind treatment period. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels. Findings: A total of 618 patients were randomized and 614 patients received at least one dose of tafolecimab (n = 411) or placebo (n = 203). At week 48, tafolecimab induced significant reductions in LDL-C levels (treatment differences versus placebo [on-treatment estimand]: -65.0% [97.5% CI: -70.2%, -59.9%] for 450 mg Q4W; -57.3% [97.5% CI: -64.0%, -50.7%] for 600 mg Q6W; both P < 0.0001). Significantly more patients treated with tafolecimab achieved ≥50% LDL-C reductions, LDL-C < 1.8 mmol/L, and LDL-C < 1.4 mmol/L than placebo group at both dose regimens (all P < 0.0001). Furthermore, tafolecimab significantly reduced non-HDL-C, apolipoprotein B, and lipoprotein(a) levels. The most commonly-reported treatment emergent adverse events in the tafolecimab groups included upper respiratory infection, urinary tract infection and hyperuricemia. Interpretation: Tafolecimab dosed at 450 mg Q4W and 600 mg Q6W was safe and showed superior lipid-lowering efficacy versus placebo, providing a novel treatment option for Chinese hypercholesterolemia patients. Funding: This study was sponsored by Innovent Biologics, Inc.
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Authors | Yong Huo, Beijian Chen, Qiufang Lian, Shuqing Wang, Lu Liu, Di Lu, Yanling Qu, Guanzhong Zheng, Lipeng Li, Yuan Ji, Guotian Yin, Wenjun Huang, Ying Xie, Xinchun Yang, Xiufang Gao, Pei An, Fengtai Xue, Haoyu Li, Huan Deng, Li Li, Lijuan Pei, Lei Qian |
Journal | The Lancet regional health. Western Pacific
(Lancet Reg Health West Pac)
Vol. 41
Pg. 100907
(Dec 2023)
ISSN: 2666-6065 [Electronic] England |
PMID | 37808342
(Publication Type: Journal Article)
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Copyright | © 2023 The Authors. |
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