AZD4144 for Cardiovascular and Kidney Disease

No longer recruiting at 19 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD4144 to evaluate its safety and effectiveness in individuals with heart and kidney problems. Researchers aim to understand how AZD4144 affects those with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD). Participants will receive either AZD4144 or a placebo for 28 days. Individuals who experienced a heart attack or stroke more than two months ago and have chronic kidney issues may be suitable for this study.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AZD4144 is likely to be safe for humans?

Research shows that AZD4144 is being tested for safety and tolerability. In earlier studies, people with serious kidney and heart problems took AZD4144, and most did not experience major side effects. However, since this is an early stage of research, the main goal is to monitor for any side effects and understand how the body processes the drug. While the initial results appear promising, the researchers are still gathering complete safety information.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD4144 because it offers a new approach to treating cardiovascular and kidney diseases. Unlike standard treatments, which often focus on managing symptoms or slowing disease progression, AZD4144 targets the underlying mechanisms of these conditions. This drug works by modulating specific pathways involved in disease progression, potentially offering more effective and targeted results. This unique mechanism of action is promising because it might address the root causes rather than just the symptoms, providing a more comprehensive treatment option.

What evidence suggests that AZD4144 might be an effective treatment for cardiovascular and kidney disease?

Research has shown that AZD4144 is under study for its potential to address heart and kidney problems. In this trial, participants will receive either AZD4144 or a placebo for 28 days. Although human studies have provided limited information so far, researchers are examining the drug's oral administration. The goal is for AZD4144 to positively affect heart disease caused by plaque buildup and chronic kidney disease. The main focus is currently on determining its safety and the body's response. Early studies are investigating the drug's action in the body, but more information is needed to confirm its efficacy.12367

Are You a Good Fit for This Trial?

This trial is for people with atherosclerotic cardiovascular disease and chronic kidney disease. Specific details about who can join are not provided, but typically participants must meet certain health criteria to ensure their safety.

Inclusion Criteria

Body mass index ≥ 18 to ≤ 45 kg/m2
Serum hsCRP > 2 mg/L
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
See 2 more

Exclusion Criteria

I have had cancer within the last 5 years.
I have not had a serious infection in the last 30 days.
I have had a heart attack, stroke, or surgery for heart or artery problems in the last 2 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive either AZD4144 or placebo for 28 days

4 weeks
Multiple visits (in-person and virtual) for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person) on Day 35 and Day 56

What Are the Treatments Tested in This Trial?

Interventions

  • AZD4144
  • Placebo
Trial Overview The study is testing AZD4144, given orally, against a placebo to see its effects on patients with heart and kidney diseases related to atherosclerosis. It aims to assess how safe the drug is and how it affects the body (pharmacodynamics).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD4144Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

A Phase 1b study to assess the safety, tolerability, and ...The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants ...
Study Details | NCT06693765 | A Study to Investigate the ...This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male ...
AZD4144 for Cardiovascular and Kidney DiseaseThe purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with ...
NCT06675175 | A Phase 1b Study to Assess the Safety, ...The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants ...
A Phase 1b Study to Assess the Safety, Tolerability, andThe purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants ...
Safety, Tolerability, Pharmacokinetics, and Target...Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Ascending Doses of Intravenous AZD4144, a Small Molecule NLRP3 Inhibitor ...
Discovery of AZD4144, a Selective and Potent NLRP3 ...Unfortunately, 2 also showed more than a 20-fold decrease in potency on NLRP3, which meant that the safety margin in vitro between hERG and ...
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