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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.
Sex: ALL
Age: 20 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Chiyoda-ku, Japan
- Chūōku, Japan
- Chūōku, Japan
- Chūōku, Japan
- Osaka, Japan
- Shinjuku-ku, Japan
- Suita-shi, Japan