This is a study to investigate the effect of AZD0780 tablets on low density lipoprotein cholesterol levels (LDL-C) compared with placebo tablets administered in combination with rosuvastatin tablets in adult Russian participants with dyslipidaemia. 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 136 days, including a screening period of up to 14 days, rosuvastatin run-in period of 28 days, treatment with AZD0780 or placebo for 84 days, and a safety follow-up period of 10 days.
This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to evaluate the effect of AZD0780 on the reduction of LDL-C, as well as its safety and tolerability, compared to placebo. The study drug will be administered orally once daily in addition to rosuvastatin for up to 12 weeks in participants receiving moderate-intensity statin therapy or not receiving any statin therapy. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical Atherosclerotic cardiovascular disease (ASCVD) or ≥ 70 mg/dL and at risk for a first ASCVD event. The study will be conducted at approximately 11 centres in Russia. The screening period is up to 14 days, starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants who meet all screening inclusion criteria and do not meet any exclusion criterion will enter a run-in period with rosuvastatin for 28 days before randomisation. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 12 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 orally once daily in addition to rosuvastatin during the treatment period, while those in the placebo group will receive matching placebo in addition to rosuvastatin. The study will include approximately 76 randomised participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
Administered orally as tablets
Administered orally as tablets
Administered orally as tablets
Research Site
Aramil, Russia
Research Site
Ivanovo, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
Relative change in Low-density lipoprotein cholesterol (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
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 Apolipoprotein (Apo) B from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on Apo B at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on non-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 lipoprotein(a) (Lp[a]) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on Lp\[a\] at 12 weeks
Time frame: Baseline - 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.