To systematically analyze the longitudinal characteristics and development trends of registered clinical trials of lipid-lowering drugs in China from 2013 to 2025, and to provide evidence-based data for clinical researchers, policy-makers, and pharmaceutical companies.

Data were retrieved from the National Medical Products Administration (NMPA) Clinical Trial Registration and Information Disclosure Platform. Clinical trials related to lipid-lowering drugs with the first public disclosure date ranging from January 1, 2013 to December 31, 2025 were included. Trials with indications containing keywords such as "cholesterol" and "hyperlipidemia" etc. were screened. After excluding duplicate registrations, comparative analyses were conducted on data regarding basic trial information, drug characteristics and the design of innovative drug trials.

A total of 748 clinical trials were included, of which 68.45% (512 cases/748 cases) were bioequivalence (BE) trials, while phase Ⅰ, Ⅱ, and Ⅲ trials accounted for 125, 47, and 64 trials respectively, totaling 31.55% (236 cases/748 cases). BE trials increased significantly from 2016 to 2019, declined during 2020 to 2022 due to the COVID-19 pandemic, and surged again after 2023. The number of innovative drug trials grew steadily, peaking in 2025. Ninety-four innovative lipid-lowering drugs identified covered diverse therapeutic targets, including proprotein convertase subtilisin/kexin type 9 (PCSK9), angiopoietin-like protein 3 (ANGPTL3), lipoprotein(a) [Lp(a)] and apolipoprotein C3 (APOC3), with 71.28% (67 cases / 94 cases) developed by domestic companies and injections dosage form accounting for 52.13% (49 cases /94 cases). The primary endpoints of phase Ⅲ trials were predominantly the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline, accounting for 65.52% (38 cases /58 cases), while hard endpoints such as major adverse cardiovascular events (MACE) accounted for only 15.52% (9 cases /58 cases). Target exploration showed a trend of diversification. Novel modalities such as small interfering RNA (siRNA) experienced explosive growth after 2023, with 24 registered trials in 2025. Only 8 innovative drug trials included subjects under 18 years old, all targeting familial hypercholesterolemia.

From 2013 to 2025, China’s lipid-lowering drug clinical trials underwent a critical transformation, shifting from generic drug expansion to active innovative drug research and development. Therapeutic targets have diversified, and novel drug modalities have developed rapidly.