A Study of AZD8233 in Participants with Dyslipidemia

Study identifier:D7990C00003

ClinicalTrials.gov identifier:NCT04641299

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Parallel, Double-blind, Placebo-controlled, Dose-ranging, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD8233 Treatment in Participants With Dyslipidemia

Medical condition

dyslipidaemia

Phase

Phase 2

Healthy volunteers

Study drug

AZD8233, Placebo

Sex

All

Actual Enrollment

119

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 28 Oct 2020

Primary Completion Date: 20 Jul 2021

Study Completion Date: 20 Jul 2021

Study design

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

Verification:

Verified 01 Sept 2022 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female.
- Participant must be 18 to 75 years of age.
- Body mass index between 19 and 40 kg/m2.
- Participants who have a fasting LDL-C ≥ 70 mg/dL but < 190 mg/dL.
- Have fasting triglycerides < 400 mg/dL.
- Should be receiving moderate- or high-intensity statin therapy.
-Should be on stable medication for ≥ 3 months prior to screening with no planned medication or dose change during study participation. The exception to this restriction is for fenofibrate; if the participant is receiving fenofibrate, the therapy must be stable for at least 6 weeks prior to randomization at a dose that is appropriate for the duration of the study in the judgement of the Investigator. Other fibrate therapy (and derivatives) are prohibited.

Exclusion Criteria

-Estimated glomerular filtration rate < 40 mL/min/1.73m2 CKD-EPI.
-Any uncontrolled or serious disease, or any medical dysfunction or surgical condition that, in the opinion of the Investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
-Poorly controlled type 2 diabetes mellitus, defined as 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 as judged by the Investigator.
-Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal
-Carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
-LDL or plasma apheresis within 12 months prior to randomization.
-Uncontrolled hypertension defined as average supine SBP > 160 mmHg or DBP > 90 mmHg at Visit 1 or Visit 3.
-Heart rate after 10 minutes supine rest < 50 bpm or > 100 bpm.
-Any laboratory values with the following deviations at Screening:
o Positive result on screening for hepatitis B, hepatitis C or HIV.
o ALT > 1.5 × ULN.
o AST > 1.5 × ULN.
o TBL > ULN.
o ALP > 1.5 × ULN.
o WBC < LLN.
o Haemoglobin < 12 g/dL in men or < 11 g/dL in women.
o Platelet count ≤ LLN.
o aPTT > ULN and PT > ULN.
o UACR > 11.3 mg/mmol (100 mg/g).
o UPCR > 300 mg/g.
-Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as judged by the Investigator.
-Mipomersen, or lomitapide within 12 months prior to randomization.
-Previous administration of AZD8233/AZD6615.
-Previous administration of PCSK9 inhibition treatment.
-Participation in another clinical study with a study intervention administered in the last 3 months prior to randomization or 5 half-lives from last dose to first administration of study intervention, whichever is the longest.

No locations available

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

Documents available

Redacted Protocol
Download
redacted Statistical Analysis Plan
Download
Redacted Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]