AZD4144 for Cardiovascular and Kidney Disease

Recruiting at 16 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AstraZeneca

Disqualifiers: Malignancy, Recent MI, Active infection, others

Trial Summary

What is the purpose of this trial?

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).

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.

Eligibility Criteria

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

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.

Trial Timeline

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

Treatment Details

Interventions

• AZD4144 (Other)
• Placebo (Other)

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).

Participant Groups

Group I: AZD4144 Experimental Treatment 1 Intervention

Participants will receive oral dose of AZD4144 for 28 days.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive oral dose of Placebo for 28 days.

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