Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study comparing different ways of increasing the dose of NNC0519-0130 in participants with overweight or obesity

This research study is for adults in the UK living with Type 2 diabetes who are also overweight or have obesity. It's called a Phase I study, which means it's an early step in testing a new medicine, NNC0519-0130. Researchers want to understand the best and safest way to increase the dose of this medicine in the body. They will be comparing different methods to see which works best and is well-tolerated. Taking part involves trying out the new medicine and having regular check-ups to make sure it's safe and to see how your body reacts. The study is open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

114

Start

15 Sep 2024

Type 2 diabetes mellitus

What is this study about?

This study is an important first step in understanding a new medicine called NNC0519-0130. When a new treatment is developed, scientists need to find out how it works in people and what the right amount (dose) is to give. This particular study is focusing on comparing different ways of increasing the dose of NNC0519-0130 in adults who have Type 2 diabetes and are also overweight or have obesity.

The main goal is to see how safe the medicine is and how well people tolerate it when the dose is increased in different ways. Researchers will be carefully monitoring participants to understand what happens when they take the medicine and to identify the best approach for future studies. This kind of early-stage research is vital for developing new and effective treatments.

Type 2 diabetes is a common condition where the body struggles to control blood sugar levels, and often, being overweight or having obesity can make it harder to manage. This new medicine aims to help people with these health challenges. By taking part, you could contribute to medical knowledge that might help many people in the future.

Key takeaways

This is an early study testing a new medicine called NNC0519-0130.
It's for adults with Type 2 diabetes who are also overweight or have obesity.
The main aim is to find the safest way to give different doses of the medicine.
You'll have regular health checks and close monitoring if you take part.
Your participation could help develop future treatments.

Who may be eligible?

This study is looking for adult volunteers. You must be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate in this research.

To be eligible, you need to have been diagnosed with Type 2 diabetes. Additionally, you should also be overweight or have obesity. The research team will be able to tell you exactly how they measure this.

There may be other reasons why you can or cannot join the study, even if you meet these main points. For instance, certain other health conditions or medications might mean you aren't suitable. The study team will review your full medical history to make sure it's safe for you to take part.

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?
Have you been diagnosed with Type 2 diabetes?
Are you currently overweight or living with obesity?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, NNC0519-0130. You won't know which way the dose is being increased, as this is part of the comparison. You'll have regular appointments at the study clinic where the research team will check your health, take blood samples, and monitor how you're feeling and how your body is reacting to the medicine.

These checks are important to make sure the medicine is safe and to see how well it's tolerated. The total length of time you'll be involved in the study will be explained in detail by the research team. It involves several visits over a period, plus follow-up checks after you finish taking the medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from taking this new medicine, as the main goal is to understand it better for future patients. However, you will receive close medical attention and contribute to important scientific knowledge. Potential risks include side effects from the study medicine, which will be carefully explained to you. You have the right to withdraw from the study at any time, for any reason, without affecting your regular 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
Austria

Common questions

What is Type 2 diabetes?

Type 2 diabetes is a condition where your body struggles to use or make enough insulin, leading to high blood sugar levels. It's often linked to being overweight or having obesity.

What does 'Phase I study' mean?

Phase I is an early stage of research. It's mainly about finding out if a new medicine is safe in people and what the right amount (dose) is to give, rather than how effective it is for the condition.

Will I get the actual medicine or a placebo?

This study focuses on comparing different ways of increasing the dose of the study medicine NNC0519-0130, so all participants will receive the active investigational drug, not a placebo (dummy medicine).

Who is funding this study?

Information about who is funding the study wouldn't usually be in the summary for patients, but the research team can provide details if you ask.

Will I be paid to take part?

Sometimes studies offer compensation for time and travel, but this can vary. The research team will be able to tell you if any such payments are offered.