A Study of AZD8233 in Participants with Dyslipidemia. - HAYATE

Study identifier:D7990C00006

ClinicalTrials.gov identifier:NCT04823611

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 and 2 Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of AZD8233 following a Multiple Subcutaneous Dose Administration in Japanese Participants With Dyslipidemia

Medical condition

Dyslipidemia

Phase

Phase 1/2

Healthy volunteers

Study drug

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

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 75 Years

Date

Study Start Date: 20 Jan 2021

Primary Completion Date: 10 Sept 2022

Study Completion Date: 10 Sept 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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

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

No locations available

Arms	Assigned Interventions
Placebo Comparator: Part A:Placebo Placebo solution for subcutaneous injection.	Drug: Part A:Placebo Placebo solution
Experimental: Part A:AZD8233 AZD8233 for subcutaneous injection.	Drug: Part A:AZD8233 PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo Comparator: Part B:Placebo Placebo solution for subcutaneous injection.	Drug: Part B:Placebo Placebo solution
Experimental: Part B:AZD8233 medium dose AZD8233 medium dose for subcutaneous injection.	Drug: Part B:AZD8233 PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Experimental: Part B:AZD8233 low dose AZD8233 low dose for subcutaneous injection.	Drug: Part B:AZD8233 PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo Comparator: Part C: Placebo Placebo solution for subcutaneous injection.	Drug: Part C: Placebo Placebo solution
Experimental: Part C: AZD8233 medium dose AZD8233 medium dose for subcutaneous injection.	Drug: Part C: AZD8233 PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.

Documents available

CSRsynopsis
Download
SAP
Download
CSPredacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]