Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study of how safe a new medicine called NNC0519‑0130 is and to test its effect in people living with excess body weight with or without type 2 diabetes

This study is testing a new medicine called NNC0519-0130. It's designed for adult individuals who are living with excess body weight, which means being overweight or having obesity. This includes those who also have type 2 diabetes. The main goal is to understand how safe the new medicine is and how it works in the body. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. Researchers hope to learn more about its effects to see if it could be a helpful treatment in the future. Participation is open to adults aged 18 and older, of all genders. Joining a study like this is always a personal choice.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

22 Jul 2024

Obesity Type 2 Diabetes with either overweight or obesity

What is this study about?

This research study is focused on a new potential medicine known as NNC0519-0130. The main purpose is to carefully check if this new medicine is safe for people to take and to learn more about how it works within the human body. This type of study is an early step in developing new treatments, often called a 'Phase I' study.

The study is looking for adults who are overweight or have obesity. This includes individuals who also have type 2 diabetes. The researchers are particularly interested in this group to see how the medicine might affect their body weight and overall health. It's important to understand that at this stage, the focus is on safety and understanding the medicine's basic effects, rather than on it being a proven treatment.

By taking part in such a study, you would be helping doctors and scientists learn more about new ways to manage weight and type 2 diabetes. This knowledge can then be used to develop better treatments for many people in the future. It's a way to contribute to medical science.

Key takeaways

This is an early study testing a new medicine for safety and effects.
It's for adults with excess body weight, including those with type 2 diabetes.
Participation helps advance understanding of these health conditions.
You'll receive close medical supervision during the study.
You can stop participating at any time.
All study-related care is at no cost to you.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. The study welcomes both men and women.

The main health requirements are that you are living with excess body weight, which means you are considered overweight or have obesity. This also includes people who have a diagnosis of type 2 diabetes in addition to being overweight or having obesity.

The research team will have a full list of specific health checks and medical history questions to make sure the study is safe and right for you. They will explain everything clearly, and you'll have the chance to ask any questions.

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 currently overweight or have obesity?
Do you have type 2 diabetes (or not, as the study covers both)?
Are you willing to attend regular clinic visits?
Are you able to take study medication as directed?
Are you comfortable with blood tests and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would typically have a number of visits to the clinic over a set period. These visits would likely involve various check-ups, such as blood tests, measuring your weight, and perhaps some other health assessments. You would be given the study medicine, NNC0519-0130, to take as instructed by the study team. They will carefully monitor you for any effects the medicine might have.

The exact number and length of visits, and how long the study lasts overall, will be explained in detail by the research team. You would also have regular contact with the study staff to discuss how you are feeling and any questions you might have. All study-related care and medication are provided at no cost, and you are free to withdraw at any time.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that you would be closely monitored by medical professionals, and you might gain early access to a new medicine that could potentially help manage your weight or type 2 diabetes, though this is not guaranteed at this early stage. The risks might include side effects from the new medicine, which are not yet fully known, or the inconvenience of regular clinic visits and tests. You will be given a full explanation of all known and potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason.

Locations (1)

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

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Unverified
Germany

Common questions

What is NNC0519-0130?

It's a new medicine being tested in this study to see if it's safe and how it works for people with excess weight, with or without type 2 diabetes.

Why is this study important?

It helps researchers learn more about new ways to manage weight and type 2 diabetes, which could lead to better treatments in the future.

Will I definitely get the new medicine?

In some studies, participants get the new medicine, while others might get a placebo (a dummy medicine) or an existing treatment for comparison. The study team will explain how this works.

What happens if I change my mind?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Will I have to pay to join the study?

No, all study-related visits, tests, and medication will be provided at no cost to you.