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

Conditions

• Dyslipidaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered orally as tablets
• AZD0780 — DRUG
  Administered orally as tablets
• Rosuvastatin — DRUG
  Administered orally as tablets

Study Details

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.

Key Dates

Start date

Nov 13, 2025

Status verified

May 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

76 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AZD0780 +Rosuvastatin
  Participants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks
• Placebo Comparator: Placebo +Rosuvastatin
  Participants will receive Rosuvastatin for 28 days. Then receive Placebo on top of rosuvastatin, administered orally for 12 weeks

Primary Outcome Measure

Relative change in Low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks [ Time Frame: Baseline - 12 weeks ]