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Anti-metabolites

Part B2 (AZD1705) for Cardiovascular

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All females must have a negative pregnancy test

Male and female of non-childbearing potential participants with suitable veins for cannulation or repeated venipuncture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: from screening (day -60 to day -2) until day 113. part b: from screening until day 141

Awards & highlights

Study Summary

This trial is looking at a medication called AZD1705 to see if it is safe and well-tolerated in people with dyslipidemia. The study will also investigate how the medication is

Who is the study for?

This trial is for Japanese or Chinese adults with dyslipidemia who have stable veins for blood draws, are on a steady statin treatment for at least 3 months, and have a BMI of 18-35. Women must not be able to bear children and need a negative pregnancy test. Smokers or those with recent serious health issues can't join.Check my eligibility

What is being tested?

The study tests AZD1705's safety and how the body processes it in people with high lipid levels compared to a placebo (a substance with no active drug). Participants will randomly receive either AZD1705 or the placebo.See study design

What are the potential side effects?

Potential side effects may include reactions related to the digestive system, liver, kidneys, blood values like abnormal hemoglobin levels, vital signs changes, ECG alterations or other organ-specific inflammation due to drug metabolism interference.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant.

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I am not able to have children and have veins suitable for frequent needle insertions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: from screening (day -60 to day -2) until day 113. part b: from screening until day 141

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: from screening (day -60 to day -2) until day 113. part b: from screening until day 141

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: from screening (day -60 to day -2) until day 113. part b: from screening until day 141 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary outcome measures

Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)

Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

Change from baseline in Apolipoprotein B (ApoB)

+7 more

Trial Design

12Treatment groups

Active Control

Placebo Group

Group I: Part B2 (AZD1705)Active Control1 Intervention

Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

Group II: Part B3 (AZD1705)Active Control1 Intervention

Participants who are receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive AZD1705 subcutaneously on Day 1 and Day 29.

Group III: Part A1 (AZD1705)Active Control1 Intervention

Non-Asian participants will receive AZD1705 subcutaneously on Day 1.

Group IV: Part A2 (AZD1705)Active Control1 Intervention

Japanese participants will receive AZD1705 subcutaneously on Day 1.

Group V: Part A3 (AZD1705)Active Control1 Intervention

Chinese participants will receive AZD1705 subcutaneously on Day 1.

Group VI: Part B1 (AZD1705)Active Control1 Intervention

Non-Asian participants who are receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

Group VII: Part A3 (Placebo)Placebo Group1 Intervention

Chinese participants will receive placebo on Day 1.

Group VIII: Part A2 (Placebo)Placebo Group1 Intervention

Japanese participants will receive placebo on Day 1.

Group IX: Part A1 (Placebo)Placebo Group1 Intervention

Non-Asian participants will receive placebo on Day 1.

Group X: Part B2 (Placebo)Placebo Group1 Intervention

Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29.

Group XI: Part B3 (Placebo)Placebo Group1 Intervention

Participants who are receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive placebo on Day 1 and Day 29.

Group XII: Part B1 (Placebo)Placebo Group1 Intervention

Non-Asian participants who are receiving moderate- or high-intensity statin therapy will receive placebo on Day 1 and Day 29.

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor

304 Previous Clinical Trials

101,040 Total Patients Enrolled

1 Trials studying Cardiovascular

112 Patients Enrolled for Cardiovascular

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,488 Total Patients Enrolled

1 Trials studying Cardiovascular

112 Patients Enrolled for Cardiovascular

Frequently Asked Questions

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

Is the clinical trial open to individuals who are older than 40 years of age?

"To be eligible for this research study, individuals must be of legal age (18 years or older) and below 65 years old."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"As per the information on clinicaltrials.gov, the current focus is on recruiting volunteers for this research. Initially shared on 1/16/2024, with the most recent update made on 1/25/2024."

Answered by AI

What is the current number of patients being recruited for participation in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is presently seeking suitable participants. Initially shared on January 16th, 2024, and most recently revised on January 25th, 2024, this trial aims to recruit a total of 112 individuals distributed across two medical facilities."

Answered by AI

What is the safety profile of Part B1 (AZD1705) in individuals undergoing treatment?

"The safety assessment for Part B1 (AZD1705) was scored as 1 by our team at Power, due to the early Phase 1 stage of the trial with only preliminary data available regarding safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia

2024. "A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06238466.