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Evaluating the safety and effects of AZD4144 in patients with heart and 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

Phase 1 Interventional AstraZeneca · NCT06675175

This study is testing if a new drug called AZD4144 is safe and effective for people with heart and kidney disease who have ongoing inflammation.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment28 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations19 sites (Glendale, California and 18 other locations)
Trial IDNCT06675175 on ClinicalTrials.gov

What this trial studies

This Phase 1b study aims to assess the safety, tolerability, and pharmacodynamics of AZD4144 in participants suffering from atherosclerotic cardiovascular disease and chronic kidney disease. Participants will be randomly assigned to receive either AZD4144 or a placebo for a treatment period of 28 days, following a 28-day screening phase. The study will also include follow-up visits to monitor participants' health and response to the treatment. The focus is on individuals with persistent inflammation as indicated by high-sensitivity C-reactive protein levels.

Who should consider this trial

Good fit: Ideal candidates include individuals with established atherosclerotic cardiovascular disease and chronic kidney disease characterized by specific inflammatory markers.

Not a fit: Patients without a history of cardiovascular disease or those with more severe chronic kidney disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with both cardiovascular and kidney diseases.

How similar studies have performed: While similar studies have explored treatments for cardiorenal diseases, the specific approach of using AZD4144 in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Participants with established ASCVD history of one or more of the following

  1. Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
  2. Prior ischemic stroke (\>60 days from index event)
  3. 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

  1. Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
  2. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
  3. Females of non-childbearing potential must be confirmed at the Screening visit

Key Exclusion Criteria:

* History of malignancy within the last 5 years
* History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
* Active systemic infection within 30 days
* Clinically significant active and chronic infections within 60 days prior to randomization
* 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

Where this trial is running

Glendale, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseaseAtherosclerotic Cardiovascular DiseaseCardiorenal diseaseEstimated glomerular filtration rateNucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 cryopyrininflammatory cytokines
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.