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Anti-metabolites

AZD1705 for Dyslipidemia

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
Must not have
History or presence of gastrointestinal, hepatic, or renal disease or any condition known to interfere with drug metabolism
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

Summary

This trial tests a new drug called AZD1705 in people with abnormal blood lipid levels. It aims to see if the drug is safe and how it behaves in the body. The study involves different doses and includes monitoring to observe effects.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that affects how drugs are broken down in my body.

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
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary study objectives
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lipid-lowering agents are crucial in managing cardiovascular disease by targeting specific enzymes or receptors involved in lipid metabolism. Statins inhibit HMG-CoA reductase, reducing cholesterol synthesis in the liver. PCSK9 inhibitors, such as evolocumab and alirocumab, prevent PCSK9 from degrading LDL receptors, enhancing the clearance of LDL cholesterol from the bloodstream. Emerging therapies like bempedoic acid and inclisiran further inhibit cholesterol synthesis or PCSK9 production, respectively. These treatments are vital for cardiovascular patients as they significantly lower LDL cholesterol levels, reducing the risk of atherosclerotic events such as heart attacks and strokes.
Do we need new lipid-lowering agents in the era of PCSK9 inhibitors? Recent advances.Mode of action of lipid-lowering drugs.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor
308 Previous Clinical Trials
101,039 Total Patients Enrolled
1 Trials studying Cardiovascular
112 Patients Enrolled for Cardiovascular
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,697 Total Patients Enrolled
1 Trials studying Cardiovascular
112 Patients Enrolled for Cardiovascular
~65 spots leftby Sep 2025
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