This trial is no longer recruiting.My employer runs this trial

AZD0780 for Elevated Cholesterol

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, AZD0780, for individuals with high levels of "bad" cholesterol (LDL-C). Participants will receive either AZD0780 or a placebo (a substance with no active medication) to compare effects. The trial targets healthy individuals with high LDL-C levels that could impact their daily health. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AZD0780 is likely to be safe for humans?

Research has shown that AZD0780, a pill designed to lower cholesterol, is generally safe for people. Studies have found that AZD0780 effectively reduces levels of LDL-C, often called "bad cholesterol," with few side effects. For example, participants experienced significant drops in their LDL-C levels, with only minor issues reported. These results suggest that AZD0780 might be safe for individuals with high cholesterol. However, as this is an early-stage trial, further research is needed to fully confirm its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for elevated cholesterol, which often include statins like atorvastatin and rosuvastatin, AZD0780 offers a fresh approach. AZD0780 is unique because it targets cholesterol in a novel way, potentially involving a new mechanism of action that differs from the traditional pathway of reducing cholesterol production in the liver. Researchers are excited about this treatment as it could offer an alternative for patients who do not respond well to or cannot tolerate current medications. This new approach might also work more efficiently or have fewer side effects, which would be a significant advancement in the management of elevated cholesterol.

What evidence suggests that AZD0780 might be an effective treatment for elevated cholesterol?

Studies have shown that AZD0780, a new pill, can significantly lower levels of LDL-C, often called "bad cholesterol." Research indicates that people taking AZD0780 experienced up to a 50.7% reduction in LDL-C over 12 weeks, with most reaching their target cholesterol levels in just two weeks. In this trial, participants will receive either AZD0780 or a matching placebo. Compared to similar drugs, this treatment offers the added benefit of once-daily dosing. Overall, it shows promise for those who haven't met their cholesterol goals with current treatments.12345

Are You a Good Fit for This Trial?

This trial is for healthy adults with high LDL cholesterol (between 70 and 190 mg/dL), a BMI between 18 and 35, and weighing at least 50 kg. Women must use effective birth control or be confirmed as not able to have children. Participants need suitable veins for blood draws.

Inclusion Criteria

I am not breastfeeding and I use effective birth control if I could become pregnant.
I am healthy and have veins suitable for blood draws.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks
1 visit (in-person)

Treatment

Participants receive AZD0780 or placebo for 28 days

4 weeks
Daily visits (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0780

Trial Overview

The study tests repeated doses of AZD0780 versus placebo in healthy adults with elevated LDL cholesterol, aiming to see how the drug affects cholesterol levels over time. It also looks at safety and how the body processes the drug.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD0780Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40167413/

An Oral PCSK9 Inhibitor for Treatment of ...

AZD0780 demonstrated robust, dose-dependent reductions in LDL-C with a favorable safety and tolerability profile supporting further ...

An Oral PCSK9 Inhibitor for Treatment of ...

A few patients on AZD0780 demonstrated an increase in LDL-C at week 12, likely attributable to noncompliance with study medications and/or ...

Efficacy and safety of AZD0780, an oral small molecule ...

The primary efficacy endpoint was percent change from baseline of LDL-C to week 12. Secondary endpoints included other lipids and hsCRP. Results ...

AZD0780, a novel oral PCSK9 inhibitor, demonstrated ...

AZD0780 is an investigational once-daily oral PCSK9 inhibitor for patients currently not reaching their LDL-C lowering goal despite standard-of-care-lipid ...

A Phase III study to assess the effect of AZD0780 on LDL-C ...

This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated ...