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A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia | Clinical Trials | Clareo Health

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A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

A Phase IIb, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants With Dyslipidemia

NCT06173570•AstraZeneca

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
•Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at screening.
•Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
•Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
•There should be no planned medication or dose change during study participation.
•Body mass index at or above 19.0 kg/m\^2.

Exclusion Criteria

•History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
•Any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
•Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
•Acute ischemic cardiovascular event in the last 12 months.
•Heart failure with New York Heart Association (NYHA) Class III-IV.
•Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
•Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal.
•LDL or plasma apheresis within 12 months prior to randomization.
•Uncontrolled hypertension.
•Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator.

Locations (55)

Research Site

Huntsville, Alabama, United States

Research Site

Lincoln, California, United States

Research Site

Palm Springs, California, United States

Research Site

Santa Ana, California, United States

Research Site

Boca Raton, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Inverness, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Louisville, Kentucky, United States

Key Dates

Start Date

January 19, 2024

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

November 17, 2025

Enrollment

428

ACTUAL participants

Conditions

Dyslipidemia

Interventions

AZD0780

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

Inclusion Criteria

Exclusion Criteria

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