A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With E… (NCT06742853) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.
United States, United Kingdom81 participantsStarted 2024-12-20
Plain-language summary
The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 on admission to the Clinical Unit
✓. Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: postmenopausal or surgically sterilized females.
✓. Have a Body Mass Index (BMI) \> 18 kg/m² and weigh at least 50 kg.
✓. Sexually active fertile male participants with partners of childbearing potential must 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 London EPCU) at the Screening Visit.
✓. Fasting triglycerides \< 400 mg/dL (or \< 10.3 mmol/L for London EPCU) at the Screening Visit.
Exclusion criteria
✕. History of any clinically important disease or disorder.
✕. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
✕. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks 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 filtration rate, or hemoglobin at the Screening Visit or on Admission
What they're measuring
1
Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C)
Timeframe: Week 4
2
Number of participants with adverse events
Timeframe: From screening (Day -56 to -29) to 14 Weeks
✕. Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or Admission to the Clinical Unit
✕. Any positive result on Screening for serum HBsAg, hepatitis B core antibody or human immunodeficiency virus.
✕. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity 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 to Screening.