NCT06675175

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).

Detailed description

This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein \[hsCRP\] \> 2 mg/L and eGlomerular filtration rate \[eGFR\] ≥ 30 to \< 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo. The study will be comprised of: * A screening period of 28 days * Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days. * A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration. The total duration of the study will be approximately 12 weeks.

Conditions

• Chronic Kidney Disease
• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	AZD4144	Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
OTHER	Placebo	Placebo will be given orally to randomized participants as per the arm they are assigned.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-10-27
• Completion: 2025-10-27
• First posted: 2024-11-05
• Last updated: 2025-11-25

Locations

15 sites across 4 countries: United States, Bulgaria, Hungary, Romania

Regulatory

• FDA-regulated drug study