This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
This is a randomised, double-blind, placebo-controlled, parallel-group Phase III study to evaluate the effect on the reduction of LDL-C and the safety and tolerability of AZD0780 versus placebo, administered as xx mg once daily orally, on top of a high intensity lipid-lowering regimen. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical ASCVD or ≥ 70 mg/dL and at risk for a first ASCVD event. The study will be conducted at approximately 470 centres in approximately 21 countries. The screening period is up to 14 days (and may be conditionally extended), starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 52 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 xx mg orally once daily during the treatment period, while those in the placebo group will receive matching placebo. The study will include approximately 2800 randomised participants. An independent data monitoring committee will, on a regular basis, review accumulating data from the study, evaluate adverse effects of the IMP, and make recommendations regarding whether to halt or modify the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,046
Research Site
Huntsville, Alabama, United States
Research Site
Irondale, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in patients on background statin therapy
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C \< 70 mg/dL at 12 weeks in patients with baseline LDL-C ≥ 70 mg/dL
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C \< 55 mg/dL at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 28 weeks
Time frame: Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 52 weeks
Time frame: Baseline - 52 weeks
Relative change in Apo B from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on apolipoprotein (Apo) B at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in non-HDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on non-high-density lipoprotein cholesterol (HDL-C) at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in total cholesterol from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on total cholesterol at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in Lp(a) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on lipoprotein(a) (Lp\[a\]) at 12 weeks
Time frame: Baseline - 12 weeks
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Sun City West, Arizona, United States
Research Site
Garden Grove, California, United States
Research Site
Gardena, California, United States
Research Site
Lancaster, California, United States
Research Site
Lincoln, California, United States
...and 394 more locations