A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). 56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

Timeline

Start

2022-05-18

Primary completion

2024-06-14

Completion

2024-06-14

Publications

• Vega RB, O'Mahony G, Barbour AM, Yu H, Knochel J, Brengdahl J, Hochdorfer T, Bergenholm L, Toppner Carlsson E, Ahnmark A, Underwood CR, Rudvik A, Carter D, Laru J, Gutgsell A, Twaddle L, Garkaviy P, Bogstedt A, Hurt-Camejo E, Miliotis T, Ryaboshapkina M, Hober A, Hubbard B, Serrano-Wu M, Kaushik V, Geschwindner S, McCarthy MC, Linden D, Rosenmeier JB. Laroprovstat, the First Oral Small-Molecule PCSK9 Inhibitor for the Treatment of Hypercholesterolemia: Results From a Randomized, Single-Blind, Placebo-Controlled Phase 1 Trial in Treatment-Naive Patients. Circulation. 2026 Jun 23;153(25):1999-2010. doi: 10.1161/CIRCULATIONAHA.125.075973. Epub 2026 May 15.

Drugs

Indications