A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
NCT ID: NCT04964557
Last Updated: 2023-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
411 participants
INTERVENTIONAL
2021-07-07
2022-07-15
Brief Summary
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Detailed Description
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The screening period starts up to 28 days before the randomization visit and ends on Day -1. Eligible participants will attend 1 enrollment visit and 15 visits during the treatment period and 2 additional visits during the safety follow up period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD8233
AZD8233 for subcutaneous use
AZD8233
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo
Placebo solution for subcutaneous injection
Placebo
Placebo solution
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
* Participants who have a fasting LDL-C ≥ 70 mg/dL (1.8 mmol/L) but \< 190 mg/dL (4.9 mmol/L) at screening
* Participants who have fasting triglycerides \< 400 mg/dL (\< 4.52 mmol/L) at screening
* Participants are receiving a stable dose (≥ 3 months) of maximally tolerated statin and/or ezetimibe therapy
* Male or female of non-childbearing potential
* Signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses
Exclusion Criteria
* History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any uncontrolled or serious disease, or any medical (eg,. known major active infection or major haematological, renal, metabolic, gastrointestinal or endocrine 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 (according to the investigator's judgment) if he/she participates in the clinical study
* Poorly controlled T2DM, defined as HbA1c \> 10%
* Acute ischaemic cardiovascular events including stroke within 30 days, or heart failure with New York Heart Association (NYHA) Class III to IV
* Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds)
* High-risk of bleeding diathesis or anti-platelet therapy other than low dose aspirin (≤100mg/day).
* Malignancy within the last 10 years
* Recipient of any major organ transplant
* LDL or plasma apheresis within 12 months prior to randomisation
* Uncontrolled hypertension defined as average supine SBP \> 160 mmHg or DBP \> 90 mmHg
* Heart rate after 10 minutes supine rest \< 50 or \> 100 bpm
* Any laboratory values with the following deviations at the Screening Visit; test may be repeated at the discretion of the investigator if abnormal:
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
* ALT \> 1.5 × ULN
* AST \> 1.5 × ULN
* TBL \> ULN
* ALP \> 1.5 × ULN
* WBC \< lower limit of normal (LLN).
* Haemoglobin \< 12 g/dL in males or \< 11 g/dL in females
* Platelet count ≤ LLN
* aPTT \> ULN or Prothrombin Time \> ULN
* UACR \> 11 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
* QTcF \> 470 ms; high degree atrioventricular (AV)-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias
* History of drug and/or alcohol abuse or a positive screen for drugs of abuse
* Use of warfarin, direct or indirect thrombin inhibitors or factor Xa inhibitors
* Mipomersen, or lomitapide within 12 months prior to randomisation
* Any fibrate therapy other than fenofibrate; if the participant is on fenofibrate therapy, the dose should be stable for at least 6 weeks prior to randomisation
* Previous administration of AZD8233/AZD6615) or inclisiran (LEQVIO ® Novartis)
* Use of evolocumab (REPATHA® Amgen) and alirocumab (PRALUENT® Regeneron) within 3 months of screening
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
Huntsville, Alabama, United States
Research Site
Canoga Park, California, United States
Research Site
Lincoln, California, United States
Research Site
Inverness, Florida, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Meridian, Idaho, United States
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Indianapolis, Indiana, United States
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New Windsor, New York, United States
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Greensboro, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Stow, Ohio, United States
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Mt. Pleasant, South Carolina, United States
Research Site
Suffolk, Virginia, United States
Research Site
Benešov, , Czechia
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Brandýs nad Labem, , Czechia
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Brno, , Czechia
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Jaroměř, , Czechia
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Liberec, , Czechia
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Louny, , Czechia
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Ostrava-Dubina, , Czechia
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Příbram, , Czechia
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Teplice, , Czechia
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Uherské Hradiště, , Czechia
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Aarhus N, , Denmark
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Herlev, , Denmark
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Herning, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Roskilde, , Denmark
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Svendborg, , Denmark
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Viborg, , Denmark
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Debrecen, , Hungary
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Orosháza, , Hungary
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Amsterdam, , Netherlands
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Doetinchem, , Netherlands
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Ede, , Netherlands
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Gouda, , Netherlands
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Harderwijk, , Netherlands
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Rotterdam, , Netherlands
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Puławy, , Poland
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Ruda Śląska, , Poland
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Tychy, , Poland
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Wierzchosławice, , Poland
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Bratislava, , Slovakia
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Brezno, , Slovakia
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Lučenec, , Slovakia
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Prešov, , Slovakia
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Rožňava, , Slovakia
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Svidník, , Slovakia
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Trebišov, , Slovakia
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A Coruña, , Spain
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Ferrol, , Spain
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L'Hospitalet de Llobregat, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Zaragoza, , Spain
Countries
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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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2020-005845-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7990C00004
Identifier Type: -
Identifier Source: org_study_id