NCT07423598

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels. The study comprises of: * An optional Pre-screening visit. * A Screening Period (maximum 28 days). * Admission to the Clinical Unit (Day -1). * A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28). * Follow-up Visit 12 ± 2 days after the last study intervention dose.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD0780	AZD0780 will be administered orally.
DRUG	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2026-02-24
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2026-02-20
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study