Phase
Condition
Dyslipidemia
Treatment
Placebo
Ezetimibe
Rosuvastatin
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed the informed consent form before any study-related procedure.
All females must have a negative serum pregnancy test at the Screening Visit and onadmission to the Clinical Unit
Females of non-childbearing potential must be confirmed at the Screening Visit byfulfilling one of the following criteria: postmenopausal or surgically sterilizedfemales.
Have a Body Mass Index (BMI) > 18 kg/m² and weigh at least 50 kg.
Sexually active fertile male participants with partners of childbearing potentialmust adhere to the contraception methods.
Fasting LDL-C > 100 mg/dL but < 190 mg/dL (> 2.6 mmol/L but < 4.9 mmol/L for LondonEPCU) at the Screening Visit.
Fasting triglycerides < 400 mg/dL (or < 10.3 mmol/L for London EPCU) at theScreening Visit.
Exclusion
Exclusion Criteria:
History of any clinically important disease or disorder.
History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 4weeks of the first administration of study intervention.
Any laboratory values with specific deviations in alanine transaminase (ALT),aspartate transaminase (AST), total bilirubin (TBL), estimated glomerular filtrationrate, or hemoglobin at the Screening Visit or on Admission
Any clinically important abnormalities in clinical chemistry, hematology, orurinalysis results other than those described under exclusion criterion number 4, atScreening and/or Admission to the Clinical Unit
Any positive result on Screening for serum HBsAg, hepatitis B core antibody or humanimmunodeficiency virus.
History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity, as judged by the investigator or history ofhypersensitivity to drugs with a similar chemical structure or class to AZD0780,ezetimibe, rosuvastatin, and bempedoic acid.
Treatment with any lipid-lowering therapy or AZD0780 within the 3 months prior toScreening.
Treatment with drugs for reduction or inhibition of Proprotein convertasesubtilisin/kexin type 9 (PCSK9) within the last 12 months prior to Screening (approved or investigational and apart from AZD0780).
Study Design
Study Description
Connect with a study center
Research Site
Harrow, HA1 3UJ
United KingdomActive - Recruiting
Research Site
Glendale, California 91206
United StatesActive - Recruiting
Research Site
Brooklyn, Maryland 21225
United StatesActive - Recruiting
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