Last updated: February 17, 2024
Sponsor: AstraZeneca
Overall Status: Active - Recruiting
Phase
2
Condition
Dyslipidemia
High Cholesterol (Hyperlipidemia)
Treatment
N/AClinical Study ID
TX322062
D7960C00006
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male 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) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than or equal to 190 mg/dL (4.9 mmol/L) at screening.
- Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
- Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
- There should be no planned medication or dose change during study participation.
- Body mass index between 19.0 and 40.0 kg/m^2.
Exclusion
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 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) greater than 10 percent at screening.
- Acute ischemic cardiovascular event in the last 12 months.
- 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.
- LDL or plasma apheresis within 12 months prior to randomization.
- Uncontrolled hypertension.
- 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.
Study Design
Study Start date:
February 05, 2024
Estimated Completion Date:
Study Description
Connect with a study center
Mid Hudson Medical Research, PLLC
New Windsor, NY 12553
United StatesActive - Recruiting
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