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

AstraZeneca

Status and phase: Begins enrollment this month; Phase 1

Conditions: Chronic Kidney Disease; Atherosclerotic Cardiovascular Disease

Treatments: Drug: AZD4144; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06675175

2024-516840-24-00 (Other Identifier)

D9441C00001

Details and patient eligibility

About

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).

Full description

This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein [hsCRP] > 2 mg/L and eGlomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo.

The study will be comprised of:

• A screening period of 28 days
• Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days.
• A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration.

The total duration of the study will be approximately 12 weeks.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

AZD4144

Experimental group

Description:

Participants will receive oral dose of AZD4144 for 28 days.

Treatment:

Drug: AZD4144

Placebo

Placebo Comparator group

Description:

Participants will receive oral dose of Placebo for 28 days.

Treatment:

Other: Placebo