Phase 1 Study of AZD4954 Safety and Effects in Healthy Adults and Adults With Dyslipidemia and Elevated Lipoproteina Levels

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD4954 in healthy adults with or without elevated Lipoproteina Lpa levels and in participants with dyslipidemia. This first-time-in-human, placebo-controlled study involves healthy males and females as well as participants with specific lipid abnormalities. The study is divided into two parts, Part A and Part B, to assess different dosing regimens and participant groups. Part A includes single ascending doses SAD of AZD4954 or placebo given on Day 1, followed by a treatment period lasting up to Day 15 and a follow-up visit around Day 29. Part B involves multiple ascending doses MAD where participants receive daily doses of AZD4954 or placebo for 21 days. Part B has global cohorts of healthy participants, participants with dyslipidemia, and a Japanese cohort, with follow-up visits occurring about 26 to 30 days after the last dose. Participants will be screened for eligibility including health status and lipid levels before admission. During the study, they will have various site visits including residential and non-residential visits, especially in Part B for dyslipidemia participants. Researchers will monitor adverse events, drug concentrations, changes in lipid levels, and other pharmacokinetic and pharmacodynamic measures. The total participation time includes screening, treatment periods, and follow-up visits extending up to approximately 49 days after dosing.

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia