NCT06675175CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 4 Nov 2024
- Start date
- 9 Dec 2024
- Primary completion date
- 27 Oct 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic kidney disease
- NCT number
- NCT06675175
- EU CT number
- 2024-516840-24-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 29
- From 9 Dec 2024 to the primary completion date, 27 Oct 2025
- 19 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
- Clinically significant active and chronic infections within 60 days prior to randomization
Other illness
- History of malignancy within the last 5 years
- Active systemic infection within 30 days
- Clinically significant recurrent infection (≥ 2× during the last 12-month period).
- Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month
Who the study is looking for
- Participants with established ASCVD history of one or more of the following
- Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
- Prior ischemic stroke (\>60 days from index event)
- Symptomatic Peripheral Arterial Disease
- Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to \< 60 mL/min/1.73 m2
- Serum hsCRP \> 2 mg/L
- Body mass index ≥ 18 to ≤ 45 kg/m2
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
- Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
- Females of non-childbearing potential must be confirmed at the Screening visit
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multi-profile Hospital for Active Treatment Heart and Brain EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Hospital St. Anna Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Acibadem City clinic University Hospital EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Gyongyos | Hungary | Completed |
| CRU Hungary Kft. Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Completed |
| Arensia Clinics S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Nova-Clin Medical Research Center S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| - Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sherman | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.