NCT06173570

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	AZD0780	AZD0780 administered orally, once daily for 12 weeks
DRUG	Placebo	Placebo administered orally, once daily for 12 weeks

Timeline

• Start date: 2024-01-19
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-12-15
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

55 sites across 8 countries: United States, Canada, Czechia, Denmark, Hungary, Japan, Slovakia, Spain

Regulatory

• FDA-regulated drug study