AZD0780: Participants will receive daily oral dose of AZD0780
Placebo: Participants will receive daily oral dose of placebo
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥ 18 years of age at the time of signing the ICF
* History of clinical ASCVD or at risk for a first ASCVD event:
1. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
2. A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds \[coronary, carotid, lower extremity\], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD.
* Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).
Thus, the background lipid-lowering therapy must consist of one of the following:
\- A high intensity LDL lowering regimen
(i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid :
OR:
\- A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended.
Participants must achieve a stable background lipid lowering therapy \> 28 days before screening.
Exclusion criteria:
* Homozygous familial hypercholesterolaemia, known diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator.
* Any of the following laboratory values at screening:
* Calculated eGFR \< 15 mL/min/1.73 m2
* AST or ALT \> 3 × ULN
* TBL \> 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
* Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)
* Creatine kinase \> 5 × ULN
* Urine albumin-to-creatinine ratio ≥ 500 mg/g
* Uncontrolled type 2 diabetes mellitus defined as HbA1C ≥ 9.5% at screening
* Inadequately treated hypothyroidism defined as TSH \> 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.
* Use of gemfibrozil within 1 week prior to screening or planned use during the study.
* Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half-lives prior to the screening visit or planned use during the study.
Primary outcome measure(s)
Relative change in LDL-C from baseline to 12 weeks — Baseline - 12 weeks To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
Trial sites (404)
Facility
City
Region
Status
Research Site
Huntsville
Alabama
Research Site
Irondale
Alabama
Research Site
Mobile
Alabama
Research Site
Gilbert
Arizona
Research Site
Phoenix
Arizona
Research Site
Sun City West
Arizona
Research Site
Garden Grove
California
Research Site
Gardena
California
Research Site
Lancaster
California
Research Site
Lincoln
California
Research Site
San Diego
California
Research Site
San Diego
California
Research Site
Torrance
California
Research Site
West Hills
California
Research Site
Hamden
Connecticut
Research Site
Boca Raton
Florida
Research Site
Hallandale
Florida
Research Site
Hialeah
Florida
Research Site
Inverness
Florida
Research Site
Jacksonville
Florida
Research Site
Miami
Florida
Research Site
New Port Richey
Florida
Research Site
Orlando
Florida
Research Site
Pembroke Pines
Florida
Research Site
Seminole
Florida
Research Site
Tampa
Florida
Research Site
Atlanta
Georgia
Research Site
Atlanta
Georgia
Research Site
Decatur
Georgia
Research Site
Peachtree Corners
Georgia
Research Site
Chicago
Illinois
Research Site
Winfield
Illinois
Research Site
Evansville
Indiana
Research Site
Evansville
Indiana
Research Site
Indianapolis
Indiana
Research Site
Ames
Iowa
Research Site
El Dorado
Kansas
Research Site
Wichita
Kansas
Research Site
Owensboro
Kentucky
Research Site
Hammond
Louisiana
+ 364 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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