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A study to investigate the effect of different doses of AZD0780 on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo and its safety and tolerability in participants 18 to 75 years of age with dyslipidemia
EU CTIS ID: 2023-506197-12-00
What this study is testing
To evaluate the effect of different doses of AZD0780 on low-density lipoprotein cholesterol (LDL-C) versus placebo in “ideal” scenarios in which intercurrent events would not occur.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males, and females of non-childbearing potential, 18 to 75 years of age, inclusive, at the time of signing the informed consent.
- Participants with a fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.
- Participants with fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at screening.
- Should be receiving moderate or high-intensity statin therapy for ≥ 2 months prior to screening, according to ACC/AHA guidelines on blood cholesterol management, or to local guidelines, eg, Japanese Atherosclerosis Society guidelines
- There should be no planned medication or dose change during study participation.
- Body mass index at or above 19.0 kg/m^2.
You likely can't join if
- Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m^2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-Epi 2021(Age, Sex)) equation at Visit 1.
- Uncontrolled hypertension defined as average sitting systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 90 mmHg at Visit 1. It is recommended that antihypertensive treatment should be considered/initiated at the principal investigator’s discretion and in accordance with applicable clinical guidelines in order to optimize blood pressure for participants with hypertension during the clinical study.
- Heart rate after 10 minutes supine rest < 50 bpm or > 100 bpm at Visit 1
- Any laboratory values with the following deviations at Screening Visit 1; test may be repeated at the discretion of the investigator if abnormal: (a) Any positive result on screening for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV). (b) Alanine Aminotransferase/Transaminase (ALT) > 1.5 × Upper Level of Normal (ULN) (c) Aspartate Aminotransferase/Transaminase (AST) > 1.5 × ULN (d) Total Bilirubin (TBL) > ULN (e) Hemoglobin < 12 g/dL in men or < 11 g/dL in women (f) Potassium < LLN
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator including shortened QTcF< 340ms; family history of long QT syndrome; PR interval shortening < 120 ms; PR interval prolongation >220 ms, intermittent second or third degree AV block or AV dissociation; persistent or intermittent complete bundle branch block, incomplete bundle branch, or interventricular conduction delay with QRS > 110 ms.
- Corrected QT Interval (QTcF) > 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
See the full eligibility criteria
Who can join
- Males, and females of non-childbearing potential, 18 to 75 years of age, inclusive, at the time of signing the informed consent.
- Participants with a fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening.
- Participants with fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at screening.
- Should be receiving moderate or high-intensity statin therapy for ≥ 2 months prior to screening, according to ACC/AHA guidelines on blood cholesterol management, or to local guidelines, eg, Japanese Atherosclerosis Society guidelines
- There should be no planned medication or dose change during study participation.
- Body mass index at or above 19.0 kg/m^2.
What rules you out
- Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m^2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-Epi 2021(Age, Sex)) equation at Visit 1.
- Uncontrolled hypertension defined as average sitting systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 90 mmHg at Visit 1. It is recommended that antihypertensive treatment should be considered/initiated at the principal investigator’s discretion and in accordance with applicable clinical guidelines in order to optimize blood pressure for participants with hypertension during the clinical study.
- Heart rate after 10 minutes supine rest < 50 bpm or > 100 bpm at Visit 1
- Any laboratory values with the following deviations at Screening Visit 1; test may be repeated at the discretion of the investigator if abnormal: (a) Any positive result on screening for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV). (b) Alanine Aminotransferase/Transaminase (ALT) > 1.5 × Upper Level of Normal (ULN) (c) Aspartate Aminotransferase/Transaminase (AST) > 1.5 × ULN (d) Total Bilirubin (TBL) > ULN (e) Hemoglobin < 12 g/dL in men or < 11 g/dL in women (f) Potassium < LLN
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator including shortened QTcF< 340ms; family history of long QT syndrome; PR interval shortening < 120 ms; PR interval prolongation >220 ms, intermittent second or third degree AV block or AV dissociation; persistent or intermittent complete bundle branch block, incomplete bundle branch, or interventricular conduction delay with QRS > 110 ms.
- Corrected QT Interval (QTcF) > 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
- Known or suspected history of drug abuse as judged by the investigator.
- History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure.
- 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 hematological, renal, metabolic, gastrointestinal, respiratory, 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.
- Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) > 10% at Visit 1.
- Acute ischemic cardiovascular event in the last 12 months prior to randomization however patients can be included if it is > 6 months from coronary artery bypass graft surgery and > 3 months after percutaneous coronary intervention.
- Heart failure with New York Heart Association (NYHA) Class III-IV
- 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.
- Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal.
- Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.