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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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.