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Arm A for High Cholesterol (PURSUIT Trial)

Phase 2

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 up to week 12

Awards & highlights

PURSUIT Trial 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.Check my eligibility

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.See study design

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.

PURSUIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

PURSUIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 up to week 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline to Week 12

Secondary outcome measures

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 outcome measures

Number of Participants with Adverse Events

PURSUIT 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

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,225 Total Patients Enrolled

9 Trials studying High Cholesterol

11,022 Patients Enrolled for High Cholesterol

AstraZeneca K.K.UNKNOWN

1 Previous Clinical Trials

180 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participation in the research project?

"Data available on clinicaltrials.gov confirms that this trial is not actively looking for new candidates, as it was initially posted on January 31st 2024 and last edited approximately 10 months ago. Nevertheless, there are 77 other medical studies currently recruiting individuals at present."

Answered by AI

Has the Food and Drug Administration sanctioned Arm B of this experiment?

"There is limited clinical evidence for the safety of Arm B resulting in it receiving a score of 2 on our internal scale. As this is a Phase 2 trial, no data exists to support its efficacy."

Answered by AI

Does this trial accept participants of a younger age?

"This medical trial imposes an age restriction of 18 years and above, with a maximum enrollment boundary set at 75."

Answered by AI

Are there any Canadian clinics currently operating this medical research?

"At present, this research study is being facilitated in 51 different sites, including Benesov, Santiago de Compostela and Sevilla. Therefore it is important to choose the nearest site to you when enrolling so as to avoid long-distance travel."

Answered by AI