Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Investigation of pharmacokinetics, safety and tolerability of a single subcutaneous dose of NNC0487-0111 in participants with various degrees of renal impairment and normal renal function.

This study is investigating a new medicine called NNC0487-0111. It's designed for adults who have both obesity and type 2 diabetes. The main goal is to understand how the body processes this medicine after a single injection under the skin. We're especially interested in how it works in people with different levels of kidney function, from normal kidneys to those with some kidney problems. We'll also be checking for any side effects and how well people tolerate the medicine. This is an early-stage study, meaning we're gathering important basic information about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

25 Jun 2024

Obesity and Diabetes mellitus Typ 2

What is this study about?

Imagine your body as a busy factory. When you take a medicine, your factory processes it, uses what it needs, and then gets rid of the rest. This study, called an early-stage trial, is like a detailed inspection of how your body's factory handles a specific new medicine, NNC0487-0111. This medicine is being developed for people who live with two common health conditions: obesity and type 2 diabetes.

The main aim is to understand a few key things. First, we want to see how quickly the medicine gets into your system, how long it stays there, and how your body breaks it down and removes it. This is important because it helps scientists figure out the best way to give the medicine in the future. Second, we're very carefully checking for any unwanted effects or side effects, and how well people feel while taking the medicine. Your safety and comfort are always the top priority.

What makes this study particularly important is that it focuses on people with different levels of kidney health. Kidneys play a big role in clearing medicines from the body. So, understanding how NNC0487-0111 works in people with normal kidney function compared to those with some kidney problems will help ensure that if this medicine becomes available, it can be used safely and effectively by a wide range of patients.

Key takeaways

This is an early study of a new medicine for obesity and type 2 diabetes.
It aims to understand how the medicine works in the body and if it's safe.
It specifically looks at how the medicine is processed by people with different kidney health.
Participation involves a single injection and several follow-up visits.
You must be an adult with both obesity and type 2 diabetes to be eligible.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.

Because this study is looking at how the body handles the new medicine, they will be including people with normal kidney function as well as those who have different levels of kidney impairment.

The study is specifically for individuals who have been diagnosed with both obesity and type 2 diabetes.

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?
Do you have a diagnosis of obesity?
Do you have a diagnosis of type 2 diabetes?
Are you able to attend several study appointments?
Are you willing to receive a single injection under your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single injection of the study medicine under your skin. Your participation will involve several visits to the clinic where the research team will perform various assessments. These will likely include blood tests to measure the medicine levels in your body, check your kidney function, and ensure your overall health. They will also monitor you closely for any side effects and ask you about how you are feeling. The exact number of visits and the total length of time you'd be involved will be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in a study like this means you might get access to a new medicine that could potentially help your conditions, though there's no guarantee. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine might not help you. All medical procedures carry some risks, such as discomfort from blood tests. You will be closely monitored by medical professionals, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is NNC0487-0111?

It's a new experimental medicine being tested for people with obesity and type 2 diabetes. It's not yet available outside of clinical trials.

What does 'single subcutaneous dose' mean?

It means you'd receive just one injection of the medicine, given under the skin, similar to how many diabetes medicines are given.

Why are they studying people with kidney problems?

Kidneys help remove medicines from the body. It's important to understand how this new medicine works in people with different kidney health to make sure it's safe for everyone.

Is this medicine available to the public?

No, this is an early-stage research study, so the medicine is not yet available for general prescription.

Will I know if I'm getting the actual medicine?

In some studies, participants know what they're receiving; in others, it's 'blinded'. The study team will explain this to you fully.