Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
119 participants
INTERVENTIONAL
2020-10-28
2021-07-20
Brief Summary
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Detailed Description
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The screening period starts up to 42 days before the randomization visit and ends on Day -1. Eligible participants will attend 7 visits during the treatment period and 7 additional visits during the safety follow up period. Eligible participants are randomized across four different treatment arms in a 1:1:1:1 ratio for a 12-week treatment period. The planned treatment arms are AZD8233 low dose, AZD8233 medium dose, AZD8233 high dose, and Placebo. Participants will be dosed SC on Days 1, 8, 29, and 57.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo solution for subcutaneous injection.
Placebo
Placebo solution
AZD8233 high dose
AZD8233 high dose for subcutaneous injection.
AZD8233
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
AZD8233 medium dose
AZD8233 medium dose for subcutaneous injection.
AZD8233
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
AZD8233 low dose
AZD8233 low does for subcutaneous injection.
AZD8233
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Interventions
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AZD8233
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo
Placebo solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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:
* Positive result on screening for hepatitis B, hepatitis C or HIV.
* ALT \> 1.5 × ULN.
* AST \> 1.5 × ULN.
* TBL \> ULN.
* ALP \> 1.5 × ULN.
* WBC \< LLN.
* Haemoglobin \< 12 g/dL in men or \< 11 g/dL in women.
* Platelet count ≤ LLN.
* aPTT \> ULN and PT \> ULN.
* UACR \> 11.3 mg/mmol (100 mg/g).
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Roseville, California, United States
Research Site
Inverness, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Meridian, Idaho, United States
Research Site
Indianapolis, Indiana, United States
Research Site
New Windsor, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Aarhus N, , Denmark
Research Site
Frederiksberg, , Denmark
Research Site
Herlev, , Denmark
Research Site
Roskilde, , Denmark
Research Site
Viborg, , Denmark
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Rožňava, , Slovakia
Research Site
Trebišov, , Slovakia
Countries
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References
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Clewe O, Rekic D, Quartino AL, Carlsson B, Higashimori M, Wernevik L, Hofherr A, Ryden-Bergsten T, Nilsson C, Knochel J. Population pharmacokinetics of a novel PCSK9 antisense oligonucleotide. Br J Clin Pharmacol. 2024 Jun;90(6):1503-1513. doi: 10.1111/bcp.16046. Epub 2024 Mar 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D7990C00003
Identifier Type: -
Identifier Source: org_study_id
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