A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

Summary

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

Timeline

Start

2024-01-19

Primary completion

2024-09-30

Completion

2024-09-30

Publications

• Koren MJ, Vega RB, Agrawal N, Xu Y, Barbour AM, Yu H, Wallerstedt E, Carter D, Middlemiss J, Twaddle L, McCarthy MC, Rosenmeier JB. An Oral PCSK9 Inhibitor for Treatment of Hypercholesterolemia: The PURSUIT Randomized Trial. J Am Coll Cardiol. 2025 Jun 3;85(21):1996-2007. doi: 10.1016/j.jacc.2025.03.499. Epub 2025 Mar 31.

Drugs

Indications