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Status:

COMPLETED

A Study of AZD8233 in Participants With Dyslipidemia.

Lead Sponsor:

AstraZeneca

Conditions:

Dyslipidemia

Eligibility:

All Genders

20-75 years

Phase:

PHASE1

PHASE2

Brief Summary

A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A , Part B and Part C. Part A is designed as a randomized, single-blind (blinding of participants and...

Detailed Description

Part A: This is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Approximately 11 Japanese participants will be randomize...

Eligibility Criteria

Inclusion

  • Key
  • Part A
  • Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent
  • Participants who have a fasting LDL-C ≥ 70 mg/dL but \< 140 mg/dL at screening
  • Participants who have fasting triglycerides \< 400 mg/dL at screening
  • Participants who should be receiving statin therapy
  • Participants who should be on stable medication for a certain time period prior to randomization
  • Body mass index (BMI) between 19 and 40 kg/m2
  • Females must not be pregnant and must have a negative pregnancy test at screening and randomisation, must not be lactating , and must be of nonchild-bearing potential
  • Part B
  • Participants must be 20 to 75 years of age inclusive, at the time of signing the informed consent
  • Have a fasting LDL-C ≥ 70 mg/dL but \< 190 mg/dL at screening (Visit 2)
  • Have fasting triglycerides \< 400 mg/dL at screening (Visit 2)
  • Should be receiving statin therapy
  • LDL-lowering medications should be on stable dosing for ≥ 3 months prior to screening with no planned medication or dose change during study participation
  • BMI between 19 and 40 kg/m2
  • Female participants must not be pregnant and must have a negative pregnancy test at screening and randomisation, must not be lactating, and must not be of childbearing potential
  • Part C
  • Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent
  • Participants who have a fasting LDL-C ≥ 70 mg/dL but \< 140 mg/dL at screening
  • Participants who have fasting triglycerides \< 400 mg/dL at screening
  • Participants who should be receiving statin therapy
  • Participants who should be on stable medication for a certain time period prior to randomization
  • Body mass index (BMI) between 19 and 40 kg/m2
  • Females must not be pregnant and must have a negative pregnancy test at screening and randomisation, must not be lactating , and must be of nonchild-bearing potential
  • Key

Exclusion

  • Part A
  • eGFR \< 60 mL/min/1.73m2 using the Japanese equation
  • Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding. Or participants receiving anti-coagulation therapy
  • History of major bleed or high-risk of bleeding diathesis
  • Subjects with a high 10-year risk of coronary heart disease as calculated using the Suita score
  • Heart rate after 10 minutes of sitting rest \< 50 or \> 100 beats per minute
  • Uncontrolled hypertension defined as sitting SBP \> 140 mmHg or DBP \> 90 mmHg
  • Part B
  • eGFR \< 40 mL/min/1.73m2 using the Japanese equation at Visit 1
  • Poorly controlled type 2 diabetes mellitus (T2DM), defined as Haemoglobin A1c (HbA1c) \> 10% at Visit 1
  • Acute ischaemic cardiovascular event in the last 12 months prior to randomization
  • Heart failure with New York Heart Association (NYHA) Class III-IV
  • High-risk of bleeding diathesis as judged by the Investigator
  • Uncontrolled hypertension defined as sitting SBP \> 160 mmHg or DBP \> 90 mmHg at Visit 1 or Visit 3
  • Heart rate after 10 minutes sitting rest \< 50 bpm or \> 100 bpm at Visit 1 or Visit 3
  • Part C
  • eGFR \< 60 mL/min/1.73m2 using the Japanese equation
  • Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding. Or participants receiving anti-coagulation therapy
  • History of major bleed or high-risk of bleeding diathesis
  • Subjects with a high 10-year risk of coronary heart disease as calculated using the Suita score
  • Heart rate after 10 minutes of sitting rest \< 50 or \> 100 beats per minute
  • Uncontrolled hypertension defined as sitting SBP \> 140 mmHg or DBP \> 90 mmHg

Key Trial Info

Start Date :

January 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 10 2022

Estimated Enrollment :

87 Patients enrolled

Trial Details

Trial ID

NCT04823611

Start Date

January 20 2021

End Date

September 10 2022

Last Update

December 24 2024

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Research Site

Chiyoda-ku, Japan, 1010041

2

Research Site

Chūōku, Japan, 103-0027

3

Research Site

Chūōku, Japan, 104-0031

4

Research Site

Chūōku, Japan, 1040031