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AZD0780 for High Cholesterol (PURSUIT Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than or equal to 190 mg/dL (4.9 mmol/L) at screening.
Must not have
History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 1 up to week 12
Awards & highlights

Summary

This trial is studying how a drug called AZD0780 affects LDL-C levels in people with dyslipidemia, and its impact on other lipids and inflammatory markers. It will also measure the drug's safety and how it is tolerated.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, generally such trials monitor for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious issues affecting organ function or causing allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old and cannot become pregnant or get someone pregnant.
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My LDL cholesterol is between 70 and 190 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any stomach, liver, or kidney diseases that affect how my body handles medicine.
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My diabetes is not well-managed, with an HbA1c over 10%.
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I have had a heart attack or stroke in the past year.
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I have severe heart failure.
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I haven't had cancer, except for specific types, in the last 10 years.
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I have received a major organ transplant.
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My blood pressure is not well-controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 1 up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 up to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline to Week 12
Secondary study objectives
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers
Percent Change from Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Other study objectives
Number of Participants with Adverse Events

Trial Design

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
Placebo, matched for appearance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD0780
2023
Completed Phase 1
~200

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,381 Total Patients Enrolled
9 Trials studying High Cholesterol
11,029 Patients Enrolled for High Cholesterol
AstraZeneca K.K.UNKNOWN
1 Previous Clinical Trials
175 Total Patients Enrolled
~48 spots leftby Nov 2024
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