Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study investigating the safety, absorption, and elimination of NNC0705-0001, a new compound that could potentially be used in the treatment of cardiometabolic diseases caused by inflammation.

This study is looking into a new medicine called NNC0705-0001. Scientists hope it could help treat medical conditions where inflammation plays a big role, such as some types of heart disease and diabetes. This is a very early-stage study, meaning it's the first time this new medicine is being given to people. The main goal is to check how safe it is and how the body takes it in, uses it, and gets rid of it. This information is really important for deciding if the medicine should be studied further for these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novo Nordisk A/S

Enrolment target

116

Start

30 May 2025

Cardiometabolic diseases with an inflammatory component

What is this study about?

This study is testing a brand new medicine, called NNC0705-0001. The reason for developing this medicine is to see if it can help people with a group of health problems known as cardiometabolic diseases. These are conditions that affect your heart, blood vessels, and how your body uses energy, and they often involve inflammation.

Inflammation is a natural process in your body, but sometimes it can get out of control and contribute to health problems. Researchers believe that by targeting this inflammation, NNC0705-0001 might be able to help. This particular study is the very first time this new medicine will be given to people. It's a really important step to understand if it's safe and well-tolerated.

In this early stage, researchers will also be carefully watching how your body takes in the medicine, how it processes it, and eventually how it gets rid of it. This information helps them understand the right amount to give and how often. All of this helps scientists decide if NNC0705-0001 has the potential to become a useful treatment in the future.

Key takeaways

This study is testing a brand new medicine, NNC0705-0001.
It's exploring if this medicine could help with conditions like heart disease and diabetes that involve inflammation.
This is the first time the medicine is being given to people.
The main goals are to check its safety and how the body handles it.
Participants must be 18 years or older, both men and women are welcome.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this study. The researchers want to look at how the new medicine affects everyone.

More specific details about your health will be discussed by the study team to make sure it's safe and appropriate for you to join. This will likely involve checking your general health and any existing conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you comfortable with regular clinic visits and medical tests?
Are you willing to take a new, untried medicine?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new medicine, NNC0705-0001. Because this is an early study, you will have several visits to the clinic so the doctors can closely monitor your health. These visits will involve various checks, such as blood tests, urine tests, and monitoring your vital signs like blood pressure and heart rate. You might also have physical examinations.

There will be a follow-up period after you've taken the medicine to make sure you are well and to collect all the necessary information. The total length of your participation, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

While we hope this new medicine will eventually help people, in this early study, the main benefit is helping scientists learn more about it. Potential benefits to you personally are not guaranteed, but you will be closely monitored by medical professionals. As with any new medicine, there could be side effects or risks, some of which may be unknown. The study team will explain all the known risks before you decide to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What are 'cardiometabolic diseases'?

These are a group of health problems that affect your heart, blood vessels, and how your body uses sugar and fat. Examples include heart disease, stroke, and type 2 diabetes.

What does 'inflammatory component' mean?

It means that a part of the disease process involves inflammation, which is your body's way of fighting off harm, but sometimes it can cause damage if it goes on for too long.

What is a 'Phase I' study?

It's the very first time a new medicine is given to people. The main goals are to check if it's safe and how the body handles it.

Will this medicine cure my condition?

This study is too early to know if NNC0705-0001 will be a cure or treatment. It's focused on safety and understanding how the medicine works in the body.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. Any study-related care and medication will be provided by the research team.