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A Study of AZD8233 in Participants With Dyslipidemia.
A Study of AZD8233 in Participants With Dyslipidemia.

NCT04823611

CompletedPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: Dyslipidemia

Interventions: Part A:Placebo, Part A:AZD8233, Part B:Placebo, Part B:AZD8233, Part C: Placebo

Countries: Japan

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 sites), placebo-controlled, multiple dose, phase 1 study. Part B is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Part C is designed as a randomized , single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study.

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

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 Criteria:

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
Locations (7)
  • Chiyoda-ku, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Osaka, Japan
  • Shinjuku-ku, Japan
  • Suita-shi, Japan