A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels
AstraZeneca
40 participants
Feb 24, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
Eligibility
Inclusion Criteria6
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
- Fasting LDL-C ≥ 70 mg/dL and < 190 mg/dL at Screening.
Exclusion Criteria6
- 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.
- Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.
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Interventions
AZD0780 will be administered orally.
Placebo will be administered orally.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07423598