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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06173570
Other study ID # D7960C00006
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 19, 2024
Est. completion date November 27, 2024

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.


Recruitment information / eligibility

Status Recruiting
Enrollment 375
Est. completion date November 27, 2024
Est. primary completion date November 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AZD0780
AZD0780 administered orally, once daily for 12 weeks
Placebo
Placebo administered orally, once daily for 12 weeks

Locations

Country Name City State
Canada Research Site Barrie Ontario
Canada Research Site Brampton Ontario
Canada Research Site Cambridge Ontario
Canada Research Site Concord Ontario
Canada Research Site Guelph Ontario
Canada Research Site Sarnia Ontario
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Czechia Research Site Benesov
Czechia Research Site Brandys nad Labem
Czechia Research Site Brno
Czechia Research Site Louny
Czechia Research Site Nachod
Czechia Research Site Praha
Czechia Research Site Pribram
Czechia Research Site Teplice
Czechia Research Site Uherske Hradiste
Denmark Research Site Aarhus
Denmark Research Site Herning
Denmark Research Site Hvidovre
Denmark Research Site Svendborg
Denmark Research Site Viborg
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Orosháza
Hungary Research Site Pécs
Japan Research Site Chuo-ku
Japan Research Site Itabashi-ku
Japan Research Site Kasuya-gun
Japan Research Site Tama-shi
Slovakia Research Site Bratislava
Slovakia Research Site Brezno
Slovakia Research Site Lucenec
Slovakia Research Site Presov
Slovakia Research Site Roznava
Slovakia Research Site Svidnik
Slovakia Research Site Trebisov
Spain Research Site Barcelona
Spain Research Site Cordoba
Spain Research Site Ferrol
Spain Research Site La Coruna
Spain Research Site Santiago de Compostela
Spain Research Site Sevilla
Spain Research Site Sevilla
Spain Research Site Sevilla
United States Research Site Boca Raton Florida
United States Research Site Chicago Illinois
United States Research Site Columbus Ohio
United States Research Site Fargo North Dakota
United States Research Site Greensboro North Carolina
United States Research Site Gurnee Illinois
United States Research Site Hialeah Florida
United States Research Site Huntsville Alabama
United States Research Site Indianapolis Indiana
United States Research Site Inverness Florida
United States Research Site Jacksonville Florida
United States Research Site Lincoln California
United States Research Site Louisville Kentucky
United States Research Site New Windsor New York
United States Research Site Palm Springs California
United States Research Site San Marcos Texas
United States Research Site Santa Ana California

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca AstraZeneca K.K.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Hungary,  Japan,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants with Adverse Events Assessment of safety and tolerability of AZD0780 compared to placebo. From first day of treatment up to week 14
Primary Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline to Week 12 Blood samples will be collected and LDL-C level for baseline up to week 12 assessed to evaluate the effect of different doses of AZD0780 compared to placebo, in 'ideal' scenarios in which intercurrent events would not occur. From first day of treatment up to week 12
Secondary Percent Change from Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Blood samples will be collected and LDL-C level for baseline up to week 12 assessed to evaluate the effect of different doses of AZD0780 compared to placebo, in 'real-world' conditions. From first day of treatment up to week 12
Secondary AZD0780 Plasma Concentrations Summarized by Sampling Timepoint Blood samples will be collected and the concentration of AZD0780 in plasma at specific timepoints used to assess the pharmacokinetics of AZD0780. From week 1 up to week 12
Secondary Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers Blood samples drawn at specific timepoints throughout the study will be assessed to evaluate the effects of different doses of AZD0780 compared to placebo from baseline at week 12, in 'ideal' scenarios in which intercurrent events do not occur, in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Non-High-Density Lipoprotein Cholesterol (non-HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C), Apolipoprotein A-1 (ApoA1), Apolipoprotein B-100 (ApoB), Lipoprotein (a) (Lp(a)), Remnant Cholesterol, and High-Sensitivity C-Reactive Protein (hsCRP). From first day of treatment up to week 12
Secondary Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers Blood samples drawn at specific timepoints throughout the study will be assessed to evaluate the effects of different doses of AZD0780 compared to placebo from baseline at week 12, in 'real-world' conditions, in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Non-High-Density Lipoprotein Cholesterol (non-HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C), Apolipoprotein A-1 (ApoA1), Apolipoprotein B-100 (ApoB), Lipoprotein (a) (Lp(a)), Remnant Cholesterol, and High-Sensitivity C-Reactive Protein (hsCRP). From first day of treatment up to week 12
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