A Study of AZD8233 in Participants With Dyslipidemia.

  • STATUS
    Recruiting
  • End date
    Apr 20, 2022
  • participants needed
    91
  • sponsor
    AstraZeneca
Updated on 7 May 2021

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.

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 randomized in an 8:3 ratio into 1 of the 2 single-blinded treatment arms; AZD8233 high dose or placebo. Participants will be dosed SC on Days 1, 8, 29, and 57.

Part B:This is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Approximately 80 Japanese participants will be randomized in a 1:1:1:1 ratio into 1 of the 4 double-blinded treatment arms; AZD8233 low dose, AZD8233 medium dose, AZD8233 high dose, or placebo. Participants will be dosed SC on Days 1, 8, 29, and 57.

Details
Condition Dyslipidemia
Treatment Part A:Placebo, Part A:AZD8233, Part B:Placebo, Part B:AZD8233
Clinical Study IdentifierNCT04823611
SponsorAstraZeneca
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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

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
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