A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
NCT ID: NCT06173570
Last Updated: 2025-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
428 participants
INTERVENTIONAL
2024-01-19
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
AZD0780, Dose 1
AZD0780
AZD0780 administered orally, once daily for 12 weeks
Arm B
AZD0780, Dose 2
AZD0780
AZD0780 administered orally, once daily for 12 weeks
Arm C
AZD0780, Dose 3
AZD0780
AZD0780 administered orally, once daily for 12 weeks
Arm D
AZD0780, Dose 4
AZD0780
AZD0780 administered orally, once daily for 12 weeks
Arm E
Placebo, matched for appearance
Placebo
Placebo administered orally, once daily for 12 weeks
Interventions
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AZD0780
AZD0780 administered orally, once daily for 12 weeks
Placebo
Placebo administered orally, once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Lincoln, California, United States
Research Site
Palm Springs, California, United States
Research Site
Santa Ana, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Inverness, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Louisville, Kentucky, United States
Research Site
New Windsor, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
San Marcos, Texas, United States
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
Toronto, Ontario, Canada
Research Site
Benešov, , Czechia
Research Site
Brandýs nad Labem, , Czechia
Research Site
Brno, , Czechia
Research Site
Louny, , Czechia
Research Site
Náchod, , Czechia
Research Site
Prague, , Czechia
Research Site
Příbram, , Czechia
Research Site
Teplice, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Aarhus, , Denmark
Research Site
Herning, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Svendborg, , Denmark
Research Site
Viborg, , Denmark
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Orosháza, , Hungary
Research Site
Pécs, , Hungary
Research Site
Chūōku, , Japan
Research Site
Itabashi-ku, , Japan
Research Site
Bratislava, , Slovakia
Research Site
Brezno, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Rožňava, , Slovakia
Research Site
Svidník, , Slovakia
Research Site
Trebišov, , Slovakia
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
Ferrol, , Spain
Research Site
Santiago(A Coruña), , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Countries
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References
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Koren MJ, Vega RB, Agrawal N, Xu Y, Barbour AM, Yu H, Wallerstedt E, Carter D, Middlemiss J, Twaddle L, McCarthy MC, Rosenmeier JB. An Oral PCSK9 Inhibitor for Treatment of Hypercholesterolemia: The PURSUIT Randomized Trial. J Am Coll Cardiol. 2025 Jun 3;85(21):1996-2007. doi: 10.1016/j.jacc.2025.03.499. Epub 2025 Mar 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2023-506197-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7960C00006
Identifier Type: -
Identifier Source: org_study_id
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