Status:
COMPLETED
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
Lead Sponsor:
AstraZeneca
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The ef...
Eligibility Criteria
Inclusion
- 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) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 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 at or above 19.0 kg/m\^2.
Exclusion
- 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 (e.g., 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.
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT06173570
Start Date
January 19 2024
End Date
September 30 2024
Last Update
November 17 2025
Active Locations (55)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Lincoln, California, United States, 95648
3
Research Site
Palm Springs, California, United States, 92262
4
Research Site
Santa Ana, California, United States, 92704