AZD0780 for High Cholesterol
(PURSUIT Trial)

Recruiting in Palo Alto (17 mi)

+54 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with high cholesterol or dyslipidemia. Participants should have a certain level of LDL-C (bad cholesterol) to join. The study excludes individuals who don't meet these specific health criteria, but the exact details aren't provided here.

Inclusion Criteria

I am between 18 and 75 years old and cannot become pregnant or get someone pregnant.

My LDL cholesterol is between 70 and 190 mg/dL.

Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.

+3 more

Exclusion Criteria

I do not have any stomach, liver, or kidney diseases that affect how my body handles medicine.

I do not have any serious health issues that could interfere with the study.

My diabetes is not well-managed, with an HbA1c over 10%.

+7 more

Participant Groups

The study tests how safe and effective four different doses of AZD0780 are compared to a placebo in lowering bad cholesterol levels over 12 weeks. It also looks at the drug's impact on other fats in the blood and inflammation markers, plus how long it stays in the body.

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm DExperimental Treatment1 Intervention

AZD0780, Dose 4

Group II: Arm CExperimental Treatment1 Intervention

AZD0780, Dose 3

Group III: Arm BExperimental Treatment1 Intervention

AZD0780, Dose 2

Group IV: Arm AExperimental Treatment1 Intervention

AZD0780, Dose 1

Group V: Arm EPlacebo Group1 Intervention