AZD4144
DrugOral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
NCT Number: NCT06675175
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).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Research Site, Pleven, Bulgaria
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:
The total duration of the study will be approximately 12 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
Placebo will be given orally to randomized participants as per the arm they are assigned.
Time frame: From first dose (Day 1) until Follow-up (Day 56±1)
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
Time frame: Day 1 to Day 28
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
Time frame: Day 1 to Day 28
The effect of AZD4144 on circulating inflammatory biomarkers IL-18 and hsCRP compared with placebo will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
The Cmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
The tmax after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
Time frame: Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)
The Ctrough after administration of AZD4144 in participants with ASCVD and CKD will be evaluated.
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07160829
Arterial Occlusive Diseases, Arteriosclerosis
Sydney, Australia
View Trial DetailsNCT07704190
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT03636152
Aortic Stiffness, Arterial Occlusive Diseases
Gainesville, Florida, United States
View Trial DetailsNCT04380467
Arterial Occlusive Diseases, Arteriosclerosis
London, Tooting, United Kingdom
View Trial Details