A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
- Conditions
- Dyslipidemia
- Registration Number
- NCT06173570
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 428
Inclusion Criteria:<br><br> - Males, and females of non-childbearing potential 18 to 75 years of age, inclusive,<br> at the time of signing the informed consent.<br><br> - Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than<br> or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at<br> screening.<br><br> - Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52<br> mmol/L) at screening.<br><br> - Should be receiving moderate or high-intensity statin therapy for more than or equal<br> to 2 months prior to screening.<br><br> - There should be no planned medication or dose change during study participation.<br><br> - Body mass index at or above 19.0 kg/m^2.<br><br>Exclusion Criteria:<br><br> - History or presence of gastrointestinal, hepatic or renal disease or any other<br> conditions known to interfere with absorption, distribution, metabolism, or<br> excretion of drugs.<br><br> - Any uncontrolled or serious disease, or any medical (e.g., known major active<br> infection or major hematological, renal, metabolic, gastrointestinal, respiratory,<br> or endocrine dysfunction) or surgical condition that, in the opinion of the<br> investigator, may either interfere with participation in the clinical study and/or<br> put the participant at significant risk.<br><br> - Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c)<br> greater than 10 percent at screening.<br><br> - Acute ischemic cardiovascular event in the last 12 months.<br><br> - Heart failure with New York Heart Association (NYHA) Class III-IV.<br><br> - Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast<br> ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.<br><br> - Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow,<br> renal.<br><br> - LDL or plasma apheresis within 12 months prior to randomization.<br><br> - Uncontrolled hypertension.<br><br> - Any clinically important abnormalities in rhythm, conduction or morphology of the<br> resting electrocardiogram (ECG) and any clinically important abnormalities in the 12<br> lead ECG as judged by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12;AZD0780 Plasma Concentrations Summarized by Sampling Timepoint;Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers;Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers