A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.
1 other identifier
interventional
81
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedStudy Start
First participant enrolled
December 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2025
CompletedNovember 10, 2025
November 1, 2025
10 months
December 16, 2024
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C)
To evaluate the effect of AZD0780 on LDL-C levels versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.
Week 4
Number of participants with adverse events
The safety and tolerability of AZD0780 when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid will be assessed.
From screening (Day -56 to -29) to 14 Weeks
Secondary Outcomes (13)
Plasma concentration of AZD0780
From Day 1 to Day 42
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
From Day 1 to Day 42
Area under concentration-time curve in the dosing interval (AUCtau) (Day 15)
From Day 1 to Day 42
Maximum observed drug concentration (Cmax)
From Day 1 to Day 42
Time to reach maximum observed concentration (tmax)
From Day 1 to Day 42
- +8 more secondary outcomes
Study Arms (6)
Ezetimibe + AZD0780
EXPERIMENTALParticipants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks.
Rosuvastatin + Ezetimibe + AZD0780
EXPERIMENTALParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort)
EXPERIMENTALParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Ezetimibe + Placebo
PLACEBO COMPARATORParticipants will receive ezetimibe 10 mg and placebo QD for 4 weeks.
Rosuvastatin + Ezetimibe + Placebo
PLACEBO COMPARATORParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort)
PLACEBO COMPARATORParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Interventions
AZD0780 tablet will be administered orally.
Ezetimibe tablet will be administered orally.
Rosuvastatin tablet will be administered orally.
Bempedoic Acid tablet will be administered orally.
Placebo will be administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Glendale, California, 91206, United States
Research Site
Brooklyn, Maryland, 21225, United States
Research Site
Harrow, HA1 3UJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2024
First Posted
December 19, 2024
Study Start
December 20, 2024
Primary Completion
October 29, 2025
Study Completion
October 29, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.