NCT07218900

A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein Cholesterol Levels (LDL-C) in Adult Participants With Dyslipidaemia

A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of AZD0780 in Combination With Rosuvastatin on Low Density Lipoprotein Cholesterol in Participants With Dyslipidaemia (LAZURE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to investigate the effect of AZD0780 tablets on low density lipoprotein cholesterol levels (LDL-C) compared with placebo tablets administered in combination with rosuvastatin tablets in adult Russian participants with dyslipidaemia. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to 136 days, including a screening period of up to 14 days, rosuvastatin run-in period of 28 days, treatment with AZD0780 or placebo for 84 days, and a safety follow-up period of 10 days.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to evaluate the effect of AZD0780 on the reduction of LDL-C, as well as its safety and tolerability, compared to placebo. The study drug will be administered orally once daily in addition to rosuvastatin for up to 12 weeks in participants receiving moderate-intensity statin therapy or not receiving any statin therapy. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical Atherosclerotic cardiovascular disease (ASCVD) or ≥ 70 mg/dL and at risk for a first ASCVD event. The study will be conducted at approximately 11 centres in Russia. The screening period is up to 14 days, starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants who meet all screening inclusion criteria and do not meet any exclusion criterion will enter a run-in period with rosuvastatin for 28 days before randomisation. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 12 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 orally once daily in addition to rosuvastatin during the treatment period, while those in the placebo group will receive matching placebo in addition to rosuvastatin. The study will include approximately 76 randomised participants.

Conditions

• Dyslipidaemia

Interventions

Type	Name	Description
DRUG	Placebo	Administered orally as tablets
DRUG	AZD0780	Administered orally as tablets
DRUG	Rosuvastatin	Administered orally as tablets

Timeline

• Start date: 2025-11-13
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-10-21
• Last updated: 2026-04-16

Locations

9 sites across 1 country: Russia