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

This article discusses the ongoing clinical trials of AZD0780, a new drug being investigated for the treatment of dyslipidemia. Dyslipidemia is a condition characterized by abnormal levels of lipids (fats) in the blood, which can increase the risk of cardiovascular diseases. The trials aim to evaluate the efficacy, safety, and tolerability of AZD0780 in lowering low-density lipoprotein cholesterol (LDL-C) levels in adults aged 18 to 75 with dyslipidemia.

Table of Contents

What is AZD0780?

AZD0780 is a new drug being developed by AstraZeneca to treat dyslipidemia, a condition characterized by abnormal levels of lipids (fats) in the blood[1]. The drug’s full chemical name is 1-[6-[[(1S,3S)-3-[[5-(DIFLUOROMETHOXY)PYRIMIDIN-2-YL]AMINO]CYCLOPENTYL]AMINO]PYRIDIN-3-YL]PYRIDIN-2-ONE, but it’s commonly referred to as AZD0780[1].

How does AZD0780 work?

While the exact mechanism of action is not fully described in the provided information, AZD0780 is designed to lower levels of low-density lipoprotein cholesterol (LDL-C) in the blood[1]. LDL-C is often referred to as “bad cholesterol” because high levels can lead to the buildup of plaque in your arteries, increasing the risk of heart disease and stroke.

What condition does AZD0780 treat?

AZD0780 is being developed to treat dyslipidemia. Dyslipidemia refers to abnormal levels of lipids (fats) in the blood. A common form of dyslipidemia is hypercholesterolemia, which is characterized by high levels of LDL cholesterol[1]. This condition is a major risk factor for cardiovascular disease (CVD), including conditions like ischemic heart disease and ischemic stroke. CVD is a leading cause of death globally and significantly contributes to disability.

Current Research on AZD0780

AZD0780 is currently being studied in a Phase IIb clinical trial. This is a crucial stage in drug development where researchers are testing different doses of the drug to determine its effectiveness, safety, and tolerability in patients with dyslipidemia[1].

Who can participate in the study?

The study is looking for participants who meet the following criteria:

  • Men and women between 18 and 75 years old
  • Have a fasting LDL-C level between 70 mg/dL (1.8 mmol/L) and 190 mg/dL (4.9 mmol/L)
  • Have been taking a moderate or high-intensity statin (a type of cholesterol-lowering medication) for at least 2 months
  • Have a body mass index of 19.0 kg/m² or higher

There are also several conditions that would exclude someone from participating, such as certain heart conditions, kidney problems, or uncontrolled high blood pressure[1].

What does the study involve?

The study is designed as a randomized, double-blind, placebo-controlled trial. This means that:

  • Participants will be randomly assigned to receive either AZD0780 or a placebo (a substance with no active drug)
  • Neither the participants nor the researchers will know who is receiving the actual drug and who is receiving the placebo
  • The study will last for 12 weeks
  • Researchers will measure the change in LDL-C levels from the start of the study to the end
  • Other measurements will include changes in other types of cholesterol and fats in the blood, as well as markers of inflammation

Potential Benefits and Risks

The potential benefit of participating in this study is the possibility of lowering your LDL cholesterol levels, which could reduce your risk of heart disease. However, as with any experimental drug, there may be unknown risks or side effects. The study will closely monitor participants’ health and safety throughout the trial[1].

It’s important to note that this drug is still in the testing phase, and more research is needed to fully understand its effectiveness and safety profile. If you’re interested in participating in this or similar clinical trials, you should discuss it with your healthcare provider to determine if it’s appropriate for your individual situation.

Aspect Details
Drug Name AZD0780
Condition Studied Dyslipidemia
Main Objective Evaluate effect on LDL-C levels
Study Design Phase IIb, multicenter, randomized, double-blind, placebo-controlled
Participant Age Range 18 to 75 years
Treatment Duration Up to 87 days
Key Inclusion Criteria Specific LDL-C levels, on statin therapy
Key Exclusion Criteria Severe medical conditions, recent cardiovascular events
Primary Endpoint Percent change in LDL-C at Week 12
Secondary Endpoints Effects on other lipid parameters, safety, tolerability

FAQ

  • What is AZD0780? AZD0780 is a new drug being tested for the treatment of dyslipidemia. It is a small molecule that aims to lower LDL cholesterol levels in the blood.
  • Who can participate in the AZD0780 clinical trials? The trials are open to adults aged 18 to 75 with dyslipidemia, who have specific LDL-C levels and are currently on statin therapy. Participants must meet certain health criteria and not have severe medical conditions that could interfere with the study.
  • What is the main goal of the AZD0780 clinical trials? The main objective is to evaluate how different doses of AZD0780 affect LDL cholesterol levels compared to a placebo. The study also aims to assess the drug's safety, tolerability, and effects on other lipid parameters and inflammatory markers.
  • How long does the clinical trial last? The treatment period for the clinical trial lasts up to 87 days (about 12 weeks). During this time, participants will receive either AZD0780 or a placebo.
  • What are the potential benefits of participating in this clinical trial? Participants may benefit from potentially improved cholesterol levels and contribute to the development of a new treatment for dyslipidemia. However, it's important to note that clinical trials also carry risks, and the effectiveness of the drug is still being studied.

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

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

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Hungary Slovakia Spain

Glossary

  • Dyslipidemia: A condition characterized by abnormal levels of lipids (fats) in the blood, which can increase the risk of cardiovascular diseases.
  • LDL-C (Low-Density Lipoprotein Cholesterol): Often called 'bad' cholesterol, high levels of LDL-C in the blood can lead to the buildup of plaque in arteries, increasing the risk of heart disease and stroke.
  • Statin therapy: A type of medication used to lower cholesterol levels in the blood by reducing the production of cholesterol by the liver.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs to determine their effectiveness.
  • HDL-C (High-Density Lipoprotein Cholesterol): Often referred to as 'good' cholesterol, HDL-C helps remove other forms of cholesterol from the bloodstream.
  • Triglycerides: A type of fat found in the blood that can contribute to the narrowing and hardening of arteries when levels are too high.
  • Apolipoprotein: Proteins that bind to fats to form lipoproteins, which help transport cholesterol and other fats through the bloodstream.
  • Lipoprotein(a): A type of lipoprotein that can contribute to the buildup of fatty deposits in arteries, increasing the risk of heart disease and stroke.
  • C-reactive protein (CRP): A protein produced by the liver that increases when there is inflammation in the body. High-sensitivity CRP tests can help assess the risk of heart disease.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-azd0780-on-cholesterol-levels-in-adults-aged-18-75-with-dyslipidemia/