A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.
NCT ID: NCT06742853
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
81 participants
INTERVENTIONAL
2024-12-20
2025-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will assess the pharmacokinetic (PK), safety, tolerability, and efficacy of AZD0780 in combination with ezetimibe, ezetimibe/rosuvastatin, and ezetimibe/bempedoic acid.
Participants will be randomized to receive either AZD0780 or placebo (to be administered with ezetimibe, ezetimibe/rosuvastatin, or ezetimibe/bempedoic acid).
The study will comprise:
1. A Screening Period of up to 28 days.
2. A Run-in Period of 28 days.
3. A Treatment Period of 28 days.
4. Two Follow-up Visits, one and two weeks after the last dose of study drug.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ezetimibe + AZD0780
Participants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks.
AZD0780
AZD0780 tablet will be administered orally.
Ezetimibe
Ezetimibe tablet will be administered orally.
Rosuvastatin + Ezetimibe + AZD0780
Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
AZD0780
AZD0780 tablet will be administered orally.
Ezetimibe
Ezetimibe tablet will be administered orally.
Rosuvastatin
Rosuvastatin tablet will be administered orally.
Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort)
Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
AZD0780
AZD0780 tablet will be administered orally.
Ezetimibe
Ezetimibe tablet will be administered orally.
Bempedoic Acid
Bempedoic Acid tablet will be administered orally.
Ezetimibe + Placebo
Participants will receive ezetimibe 10 mg and placebo QD for 4 weeks.
Ezetimibe
Ezetimibe tablet will be administered orally.
Placebo
Placebo will be administered orally.
Rosuvastatin + Ezetimibe + Placebo
Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Ezetimibe
Ezetimibe tablet will be administered orally.
Rosuvastatin
Rosuvastatin tablet will be administered orally.
Placebo
Placebo will be administered orally.
Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort)
Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Ezetimibe
Ezetimibe tablet will be administered orally.
Bempedoic Acid
Bempedoic Acid tablet will be administered orally.
Placebo
Placebo will be administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD0780
AZD0780 tablet will be administered orally.
Ezetimibe
Ezetimibe tablet will be administered orally.
Rosuvastatin
Rosuvastatin tablet will be administered orally.
Bempedoic Acid
Bempedoic Acid tablet will be administered orally.
Placebo
Placebo will be administered orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. All females must have a negative serum pregnancy test at the Screening Visit and on admission to the Clinical Unit
3. Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: postmenopausal or surgically sterilized females.
4. Have a Body Mass Index (BMI) \> 18 kg/m² and weigh at least 50 kg.
5. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
6. 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.
7. Fasting triglycerides \< 400 mg/dL (or \< 10.3 mmol/L for London EPCU) at the Screening Visit.
Exclusion Criteria
2. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
4. 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
5. 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
6. Any positive result on Screening for serum HBsAg, hepatitis B core antibody or human immunodeficiency virus.
7. 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.
8. Treatment with any lipid-lowering therapy or AZD0780 within the 3 months prior to Screening.
9. Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to Screening (approved or investigational and apart from AZD0780).
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Research Site
Harrow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D7960C00017
Identifier Type: -
Identifier Source: org_study_id