NCT06675175

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2024

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 4, 2024

Last Update Submit

November 24, 2025

Conditions

Chronic Kidney DiseaseAtherosclerotic Cardiovascular Disease

Keywords

Cardiorenal diseaseEstimated glomerular filtration rateNucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (NLRP3) cryopyrininflammatory cytokines

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events

    The safety and the tolerability of AZD4144 compared with placebo will be evaluated.

    From first dose (Day 1) until Follow-up (Day 56±1)

  • Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels

    The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.

    Day 1 to Day 28

Secondary Outcomes (4)

  • Relative change from baseline to 4 weeks in systemic IL-18 and High-sensitivity C-reactive protein (hsCRP) levels

    Day 1 to Day 28

  • Maximum plasma drug concentration (Cmax)

    Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)

  • Time to reach maximum observed concentration (tmax)

    Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)

  • Observed lowest concentration before the next dose is administered (Ctrough)

    Day 1 to Day 28 (pre-dose), Day 1 and Day 22±1 (post-dose)

Study Arms (2)

AZD4144

EXPERIMENTAL

Participants will receive oral dose of AZD4144 for 28 days.

Drug: AZD4144

Placebo

PLACEBO COMPARATOR

Participants will receive oral dose of Placebo for 28 days.

Other: Placebo

Interventions

AZD4144DRUG

Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.

AZD4144
PlaceboOTHER

Placebo will be given orally to randomized participants as per the arm they are assigned.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Glendale, California, 91203, United States

Location

Research Site

Daytona Beach, Florida, 32117, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami, Florida, 33125, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Tampa, Florida, 33603, United States

Location

Research Site

Farmington Hills, Michigan, 48334, United States

Location

Research Site

The Bronx, New York, 10455, United States

Location

Research Site

Sherman, Texas, 75092, United States

Location

Research Site

Pleven, 5800, Bulgaria

Location

Research Site

Sofia, 1527, Bulgaria

Location

Research Site

Gyöngyös, 3200, Hungary

Location

Research Site

Kistarcsa, 2143, Hungary

Location

Research Site

Bucharest, 11658, Romania

Location

Research Site

Cluj-Napoca, 400006, Romania

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicAtherosclerosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

December 9, 2024

Primary Completion

October 27, 2025

Study Completion

October 27, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

RO(2)BU(2)US(9)HU(2)