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PCSK9 inhibitor recaticimab for hypercholesterolemia on stable statin dose: a randomized, double-blind, placebo-controlled phase 1b/2 study.
- Source :
-
BMC Medicine . 1/17/2022, Vol. 20 Issue 1, p1-13. 13p. - Publication Year :
- 2022
-
Abstract
- <bold>Background: </bold>Recaticimab (SHR-1209, a humanized monoclonal antibody against PCSK9) showed robust LDL-C reduction in healthy volunteers. This study aimed to further assess the efficacy and safety of recaticimab in patients with hypercholesterolemia.<bold>Methods: </bold>In this randomized, double-blind, placebo-controlled phase 1b/2 trial, patients receiving stable dose of atorvastatin with an LDL-C level of 2.6 mmol/L or higher were randomized in a ratio of 5:1 to subcutaneous injections of recaticimab or placebo at different doses and schedules. Patients were recruited in the order of 75 mg every 4 weeks (75Q4W), 150Q8W, 300Q12W, 150Q4W, 300Q8W, and 450Q12W. The primary endpoint was percentage change in LDL-C from the baseline to end of treatment (i.e., at week 16 for Q4W and Q8W schedule and at week 24 for Q12W schedule).<bold>Results: </bold>A total of 91 patients were enrolled and received recaticimab and 19 received placebo. The dose of background atorvastatin in all 110 patients was 10 or 20 mg/day. The main baseline LDL-C ranged from 3.360 to 3.759 mmol/L. The least-squares mean percentage reductions in LDL-C from baseline to end of treatment relative to placebo for recaticimab groups at different doses and schedules ranged from -48.37 to -59.51%. No serious treatment-emergent adverse events (TEAEs) occurred. The most common TEAEs included upper respiratory tract infection, increased alanine aminotransferase, increased blood glucose, and increased gamma-glutamyltransferase.<bold>Conclusion: </bold>Recaticimab as add-on to moderate-intensity statin therapy significantly and substantially reduced the LDL-C level with an infrequent administration schedule (even given once every 12 weeks), compared with placebo.<bold>Trial Registration: </bold>ClinicalTrials.gov , number NCT03944109. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 17417015
- Volume :
- 20
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- BMC Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 154713174
- Full Text :
- https://doi.org/10.1186/s12916-021-02208-w