What side effects are associated with this type of intervention?

Common treatments for high cholesterol include statins, PCSK9 inhibitors, ezetimibe, and fibrates. Statins are generally well-tolerated but can cause muscle toxicity and elevated liver enzymes. PCSK9 inhibitors, such as alirocumab and evolocumab, are effective in lowering LDL-C and have a side effect profile similar to placebo, with mild injection site reactions and rare hypersensitivity reactions. Ezetimibe is usually well-tolerated with minimal side effects. Fibrates can cause gastrointestinal issues and, rarely, muscle toxicity. Overall, these treatments are effective in managing high cholesterol with manageable side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of high cholesterol that modulate cholesterol metabolism and cardiovascular health. Statins, such as atorvastatin and rosuvastatin, are widely used for their efficacy in lowering LDL-C levels. PCSK9 inhibitors, including alirocumab and evolocumab, have also been approved and are effective in patients with familial hypercholesterolemia or those who require additional LDL-C lowering beyond statins and ezetimibe. Other treatments like bempedoic acid and ezetimibe are used in combination with statins to further reduce cholesterol levels. These therapies collectively aim to lower LDL-C and reduce the risk of cardiovascular events.

What other types of research exist?

Promising novel alternatives to AZD0780 for high cholesterol patients include PCSK9 inhibitors (e.g., alirocumab, evolocumab), which have shown efficacy in reducing LDL-C levels and cardiovascular events. Synthetic LXR ligands are also under investigation for their potential to regulate lipid homeostasis. Additionally, secondary agents like ezetimibe and niacin can be considered as adjunct therapies to traditional statin treatment.

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AZD0780 for High Cholesterol

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Has received another new chemical entity within 30 days or 5 half-lives of the first administration of IMP in this study

Current smokers or those who have smoked or used nicotine products within the previous 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43

Summary

This trial is testing a new drug called AZD0780 to see if it is safe and how it works in the body. The study involves healthy adults, including some with high cholesterol. Researchers will monitor how the drug is processed in the body and its effects on cholesterol levels.

Who is the study for?

This trial is for healthy adults aged 18-55 with suitable veins for cannulation, a BMI of 18-35 kg/m2, and weighing between 50-120 kg. Japanese or Chinese heritage individuals are eligible based on specific criteria. Women must not be pregnant or able to become pregnant. Participants should have LDL-C levels within certain ranges and cannot have had significant medical procedures, drug abuse history, excessive alcohol consumption, recent vaccinations, or any condition affecting drug absorption.

What is being tested?

The study tests the safety and effects of AZD0780 on cholesterol levels in healthy subjects with/without high LDL-C. It involves single/multiple doses compared against Rosuvastatin (a known cholesterol-lowering medication) and Placebo over two parts involving up to 172 participants.

What are the potential side effects?

Potential side effects may include reactions typical of clinical trials such as discomfort at the injection site, nausea, headaches or dizziness; however specific side effects will be monitored given this is an assessment of safety and tolerability.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any new drugs within the last 30 days or 5 half-lives before starting this study.

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I have smoked or used nicotine products in the last 3 months.

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I have tested positive for COVID-19 with a PCR test during screening.

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I can communicate clearly with my doctor.

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I haven't taken any medication, including over-the-counter and herbal remedies, for the last 2 weeks.

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I have not taken AZD0780 in the last 60 days.

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I haven't donated blood or plasma in the last month.

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I haven't taken drugs like St John's Wort in the last 3 weeks.

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I have no conditions that affect how my body handles medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43

This trial's timeline: 3 weeks for screening, Varies for treatment, and ldl-c sad cohorts: days 1,2,3,5-7,9-11 ldl-c jsmad cohorts: days 1,2,3,10,15,16,17;ldl-c global mad cohorts: days 1,2,3,5,8,12,22, 25,29,36-43;ldl-c rosuvastatin global mad cohorts:days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43 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 subjects with Adverse Events

Secondary study objectives

Amount of unchanged drug excreted into urine from zero to the last quantifiable concentration by interval and cumulatively (Ae[0-last])

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

Area under plasma concentration time curve from zero to t hours post-dose (AUC[0-t])

+6 more

Trial Design

14Treatment groups

Active Control

Group I: Cohort 5: Part A1 - AZD0780 dose 5/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.

Group II: Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12Active Control3 Interventions

A total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin.

Group III: Cohort 13: Part B - placebo tablet/rosuvastatin dose 12Active Control2 Interventions

A total of 20 subjects will receive single dose of placebo and rosuvastatin.

Group IV: Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12Active Control2 Interventions

A total of 20 subjects will receive single dose of AZD0780 and rosuvastatin.

Group V: Cohort 10: Part B - AZD0780 dose 10/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.

Group VI: Cohort 4: Part A1 - AZD0780 dose 4/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.

Group VII: Cohort 6: Part B - AZD0780 dose 6/placebo tabletActive Control2 Interventions

A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.

Group VIII: Cohort 7: Part B - AZD0780 dose 7/placebo tabletActive Control2 Interventions

A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.

Group IX: Cohort 2: Part A1 - AZD0780 dose 2/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.

Group X: Cohort 3: Part A1 - AZD0780 dose 3/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.

Group XI: Cohort 9: Part B - AZD0780 dose 9/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.

Group XII: Cohort 11: Part A2 - AZD0780 dose 11/placebo tabletActive Control2 Interventions

A total of 5 subjects will receive single ascending doses of AZD0780 and placebo.

Group XIII: Cohort 8: Part B - AZD0780 dose 8/placebo tabletActive Control2 Interventions

A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.

Group XIV: Cohort 1: Part A1 - AZD0780 dose 1/placebo tabletActive Control2 Interventions

A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.

0 / 9Eligibility criteria met

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

Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors. Statins inhibit the enzyme HMG-CoA reductase, reducing cholesterol synthesis in the liver. Ezetimibe blocks cholesterol absorption in the small intestine. PCSK9 inhibitors increase LDL receptors on liver cells, enhancing LDL-C clearance from the bloodstream. These treatments are vital for high cholesterol patients as they effectively lower LDL-C levels, reducing the risk of cardiovascular diseases.

2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult.Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia.Clinical perspective: have the results of recent clinical trials of lipid-lowering therapies influenced the way we should practice? A Latin American perspective of current issues in clinical lipidology.