Praluent (alirocumab)

Combined proteomics and lipidomics analyses was conducted on plasma from 265 patients with acute MI from the PACMAN-AMI (Effects of the PCSK9 Antibody Alirocumab on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction) randomized, placebo-controlled PCSK9 mAb trial and 34 patients without MI with hyperlipidemia from the Vienna Lipid Clinic registry, also receiving PCSK9 mAbs...Combining PCSK9 mAbs with high-intensity statins mitigates post-MI increases in lipoprotein(a). URL: https://www.clinicaltrials.gov; Unique identifier: NCT03067844.

P=N/A, N=1500, Recruiting, Federico II University

P4, N=160, Recruiting, Shanghai Tong Ren Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Jun 2026

P2, N=60, Active, not recruiting, Duke University | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2026 --> Sep 2025

P=N/A, N=5000, Recruiting, Federico II University | N=2000 --> 5000 | Trial completion date: Mar 2024 --> Mar 2030

P1, N=100, Recruiting, National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

P3, N=118, Completed, University of California, San Francisco | Recruiting --> Completed | Trial completion date: Aug 2026 --> Aug 2025

Alirocumab and atorvastatin effectively attenuated myocardial I/R injury in T2DM by modulating lipid metabolism, inflammation, and apoptosis. Diabetes substantially intensified I/R-induced cardiac injury, underscoring the importance of metabolic control in cardioprotection. #Means they contributed equally to the article.

Alirocumab-facilitated 5-FU therapy effectively suppresses PCSK9-promoted CRC proliferation/growth/invasion, highlighting that alirocumab therapy may be an alternative choice of adjuvant therapy in combination with surgery or chemotherapy.

P2/3, N=478, Not yet recruiting, Nanfang Hospital, Southern Medical University

P2, N=60, Active, not recruiting, Duke University | Recruiting --> Active, not recruiting | Trial completion date: Jan 2029 --> Jan 2027 | Trial primary completion date: Jan 2027 --> Jan 2026

Notably, anti-PCSK9 antibodies like alirocumab and evolocumab have demonstrated significant reductions in LDL-C levels and cardiovascular events in large-scale clinical trials. Overall, monoclonal antibody therapy represents a significant advancement in the management of atherosclerosis, with ongoing research aimed at optimizing efficacy, safety, and accessibility. Future directions include the development of novel mAbs and combination therapies to further improve cardiovascular outcomes in patients with atherosclerotic disease.