A Study of AZD8233 in Participants With Dyslipidemia.

• Status: Recruiting
• Trial end date: 2022-04-20
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A and Part B. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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

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