A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidaemia

In brief

AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate safety, efficacy and tolerability of AZD8233.

Key facts

Study ID

NCT04964557

Run by

AstraZeneca

People needed

411

Starts

2021-07-07

Expected to finish

2022-07-15

Last updated by the study team

2023-12-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be 18 to 75 years of age, inclusive, at the time of signing the informed consent
• 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

You may not qualify if…

• eGFR < 40 mL/min/1.73m2 using the CKD-EPI
• 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

Where it is running

• Research Site — Canoga Park, California, United States
• Research Site — Lincoln, 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 — Cincinnati, Ohio, United States
• Research Site — Stow, Ohio, United States
• Research Site — Mt. Pleasant, South Carolina, United States
• Research Site — Suffolk, Virginia, United States
• Research Site — Benešov, Czechia
• Research Site — Brandýs nad Labem, Czechia
• Research Site — Brno, Czechia
• Research Site — Jaroměř, Czechia
• Research Site — Liberec, Czechia
• Research Site — Louny, Czechia
• Research Site — Ostrava-Dubina, Czechia
• Research Site — Příbram, Czechia
• Research Site — Teplice, Czechia
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.