CompletedPhase 1

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

United States29 participantsStarted 2024-12-09

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

What they're measuring

Number of participants with adverse events

Timeframe: 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

Timeframe: Day 1 to Day 28

Trial details

NCT IDNCT06675175

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-27

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