Actively Recruiting
A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein Cholesterol Levels (LDL-C) in Adult Participants With Dyslipidaemia
Led by AstraZeneca · Updated on 2026-04-16
76
Participants Needed
9
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein Cholesterol Levels (LDL-C) in Adult Participants With Dyslipidaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of signing informed consent
- History of clinical ASCVD (including myocardial infarction, angina, arterial revascularisation, ischemic stroke, or peripheral artery disease) or at risk for a first ASCVD event
- Fasting LDL-C 65 mg/dL in participants with clinical ASCVD or 70 mg/dL in participants without clinical ASCVD but at risk
- Stable use of lipid-lowering therapy including moderate statins, stable use of lipid-lowering therapy without statins, or no lipid-lowering therapy before screening
You will not qualify if you...
- Homozygous or known heterozygous familial hypercholesterolaemia, recent LDL or plasma apheresis, or any condition interfering with study results
- Laboratory abnormalities at screening including eGFR < 15 mL/min/1.73 m2, AST or ALT > 3 times upper limit, total bilirubin > 2 times upper limit (except Gilbert's syndrome with specific limits), fasting triglycerides 600 mg/dL, creatine kinase > 5 times upper limit, or urine albumin-to-creatinine ratio 600 mg/g
- Uncontrolled type 2 diabetes (HbA1C 6 9.5%)
- Untreated or inadequately treated hypothyroidism or recent changes in thyroid therapy
- Use of mipomersen, lomitapide, gemfibrozil, or PCSK-9 inhibitors within specified timeframes prior to screening or planned use during the study
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Research Site
Aramil, Russia, 624002
Actively Recruiting
2
Research Site
Ivanovo, Russia, 153012
Actively Recruiting
3
Research Site
Moscow, Russia, 105554
Actively Recruiting
4
Research Site
Moscow, Russia, 111539
Actively Recruiting
5
Research Site
Moscow, Russia, 117292
Actively Recruiting
6
Research Site
Moscow, Russia, 121552
Actively Recruiting
7
Research Site
Perm, Russia, 614000
Actively Recruiting
8
Research Site
Saint Petersburg, Russia, 194156
Actively Recruiting
9
Research Site
Saratov, Russia, 410054
Suspended
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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