Study on the Effects of AZD0780 on Cholesterol Levels in Adults Aged 18-75 with Dyslipidemia

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called AZD0780 on a condition known as dyslipidemia. Dyslipidemia is a medical condition where there are abnormal levels of lipids, such as cholesterol, in the blood. A common form of dyslipidemia is high levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad” cholesterol, which can increase the risk of cardiovascular diseases like heart disease and stroke.

The purpose of this study is to evaluate how different doses of AZD0780 affect LDL-C levels compared to a placebo. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will last for a period of 12 weeks, during which the safety and tolerability of AZD0780 will also be assessed. This means that researchers will monitor any side effects or health changes in participants to ensure the treatment is safe.

Throughout the study, participants will take the medication in the form of a film-coated tablet, which is taken orally. The study aims to provide valuable information on how AZD0780 can help manage cholesterol levels in people with dyslipidemia, potentially offering a new treatment option for those at risk of cardiovascular diseases.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and cholesterol levels.

You will be asked to provide a fasting blood sample to measure your low-density lipoprotein cholesterol (LDL-C) and triglycerides. Your current medication regimen will be reviewed to ensure no changes are planned during the study.

2 randomization

After confirming eligibility, you will be randomly assigned to one of the study groups. This means you may receive either the study medication AZD0780 or a placebo, which looks like the medication but does not contain the active ingredient.

The study is double-blind, meaning neither you nor the study staff will know which group you are in.

3 medication administration

You will take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol, and you will be instructed on how to take the medication correctly.

The duration of medication administration is planned for 12 weeks.

4 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the medication.

During these visits, blood samples will be taken to measure changes in your cholesterol levels and other health markers. Your vital signs and overall health will also be assessed.

5 final assessment

At the end of the 12-week period, you will have a final assessment. This will include a comprehensive evaluation of your cholesterol levels and any changes from the start of the study.

The study team will review any side effects or adverse events you may have experienced during the trial.

Who Can Join the Study?

Men and women who cannot have children, aged 18 to 75 years old.
Participants must have a fasting low-density lipoprotein cholesterol (LDL-C) level between 70 mg/dL (1.8 mmol/L) and 190 mg/dL (4.9 mmol/L) at the start of the study. LDL-C is often called “bad cholesterol” because high levels can lead to heart disease.
Participants must have fasting triglycerides less than 400 mg/dL (4.52 mmol/L) at the start of the study. Triglycerides are a type of fat found in your blood.
Participants should have been taking moderate or high-intensity statin therapy for at least 2 months before the study starts. Statin therapy involves medications that help lower cholesterol levels in the blood.
There should be no planned changes in medication or dosage during the study.
Participants must have a body mass index (BMI) of 19.0 kg/m² or higher. BMI is a measure of body fat based on height and weight.

Who Cannot Join the Study?

Patients with any serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to the study medication.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures.
Patients with a history of heart disease, such as a heart attack or stroke.
Patients taking medications that might interfere with the study drug.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kardiomed s.r.o.	Lučenec	Slovakia

Other Sites

Site Name	City	Country
Areteus s.r.o.	Trebisov	Slovakia
Hospital Universitario Virgen De Valme	Sevilla	Spain
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet	Budapest	Hungary
Medispol s.r.o.	Presov	Slovakia
MediTask s.r.o.	Bratislava	Slovakia
Innera s.r.o.	Benesov	Czechia
Odense University Hospital	Odense	Denmark
University Of Debrecen	Debrecen	Hungary
Medicus Services s.r.o.	Brandys Nad Labem	Czechia
Clinical Trials Service s.r.o.	Uherske Hradiste	Czechia
Virgen del Rocío University Hospital	Sevilla	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Region Midtjylland	Aarhus	Denmark
Centrum pro zdravi s.r.o.	Brno-Stred	Czechia
Kardiologicke centrum MUDr. Janky Skrobakove s.r.o.	Prague	Czechia
University Of Pecs	Pecs	Hungary
Interna SK s.r.o.	Svidnik	Slovakia
Area Sanitaria De Ferrol	Ferrol	Spain
KardioBusak s.r.o.	Louny	Czechia
Edumed s.r.o.	Nachod	Czechia
DIAB s.r.o.	Roznava	Slovakia
High Tech Medical Kft.	Budapest	Hungary
DermaMed Research Kft.	Oroshaza	Hungary
Kardiologicka ambulance s.r.o.	Příbram	Czechia
Hsnghrei Hwfrqwpg	Hvidovre	Denmark
Asyzhs Ubcjllbfjp Hpsgweua	Aarhus	Denmark
Hvxycmhk Df La Swewb Cwej I Smrx Psr	Barcelona	Spain
Natfqwwfr S Pohkzceoqhca Bstrpe Nrft	Brezno	Slovakia
Hnphrpva Urhqbhwqwgvtn dd A Cgjzbw	A Coruna Galicia	Spain
Uoviame Dcsxxoutpxc kuin	Teplice	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.02.2024
Denmark	Not recruiting	12.02.2024
Hungary	Not recruiting	12.02.2024
Slovakia	Not recruiting	12.02.2024
Spain	Not recruiting	12.02.2024

Trial locations

Investigated drugs:

1-[6-[[(1S,3S)-3-[[5-(Difluoromethoxy)Pyrimidin-2-Yl]Amino]Cyclopentyl]Amino]Pyridin-3-Yl]Pyridin-2-One

AZD0780 is a medication being studied for its potential to help people with dyslipidemia, a condition where there are unhealthy levels of lipids, like cholesterol, in the blood. This medication is being tested to see if it can lower the levels of bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C), which is often linked to heart disease. The study aims to find out how effective and safe AZD0780 is for patients, and whether it can be a good option for managing cholesterol levels without causing significant side effects.

Investigated diseases:

Dyslipidaemia

Dyslipidemia – Dyslipidemia refers to an abnormal amount of lipids in the blood. It often involves high levels of low-density lipoprotein cholesterol (LDL-C), which is commonly known as “bad” cholesterol. This condition can lead to the buildup of cholesterol in the arteries, increasing the risk of cardiovascular diseases. Over time, the accumulation of cholesterol can cause narrowing and hardening of the arteries, a process known as atherosclerosis. Dyslipidemia can also involve low levels of high-density lipoprotein cholesterol (HDL-C) or high levels of triglycerides. These lipid imbalances can contribute to the development of heart disease and stroke.

Trial ID:

2023-506197-12-00

Protocol code:

PURSUIT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of AZD0780 on Cholesterol Levels in Adults Aged 18-75 with Dyslipidemia

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