RecruitingPHASE1INTERVENTIONAL

A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity

This research study is investigating a new medicine called NNC0487-0111. It aims to understand if and how this medicine influences food intake, feelings of hunger (appetite), and how the body processes food after eating, specifically in people who have obesity. Participants will be taking part in a 'Phase 1' trial, which means it's one of the first times this medicine is being tested in humans. They will receive either the actual medicine or a placebo (a treatment with no active drug) as a weekly injection under the skin of their stomach. The choice of which treatment a participant gets is made randomly, like flipping a coin. The study wants to compare the effects of the new medicine against the placebo to see if it makes a difference.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novo Nordisk A/S

Enrolment target

120

Start

30 Mar 2026

Estimated completion

22 Jan 2028

Obesity

What is this study about?

This study is about a new medicine called NNC0487-0111, and it's looking at how it might help people who live with obesity. We know that managing obesity can be challenging, and researchers are always looking for new ways to support individuals. This particular study wants to understand if this new medicine can affect three main things: how much you eat, how hungry you feel, and how your body uses energy from food after you've eaten.

This is a 'Phase 1' study, which means it's an early stage of testing for this medicine. It's about gathering important information on how it works in the body and if it's safe. When you take part, you'll be given either the new medicine (NNC0487-0111) or a placebo. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This is a common and important step in medical research, as it helps doctors tell if any changes seen are truly because of the medicine or due to other factors.

The medicine, or the placebo, will be given once a week as a small injection under the skin, similar to how some people with diabetes manage their condition. Researchers will then carefully monitor participants to see if NNC0487-0111 makes a difference compared to the placebo. The goal is to see if this medicine could potentially be a helpful option in the future for people with obesity, by influencing appetite and metabolism.

Key takeaways

This study is testing a new medicine for obesity.
It aims to understand effects on food intake, appetite, and metabolism.
Participants will receive weekly injections (either medicine or placebo).
It's a Phase 1 study, focusing on safety and how the medicine works.
Participation requires regular check-ups and medical monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be a man or woman between 18 and 64 years old. The research team will do a health check-up, including looking at your medical history, doing a physical exam, and some simple tests like blood pressure and blood tests, to make sure it's safe for you to take part. Your excess weight should be due to extra body fat, as determined by the study doctor.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, planning to become pregnant, or could become pregnant and aren't using effective birth control. If you have ever had type 1 or type 2 diabetes, or if a specific blood test for diabetes (called HbA1c) shows your sugar levels are too high, you won't be able to participate. Also, if you've recently lost a lot of weight (5% or more) or been on a strict diet in the last three months, or if you have certain other serious health conditions related to your breathing, heart, kidneys, stomach, or hormones, then this study might not be suitable for you.

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 between 18 and 64 years old?
Is your excess weight due to extra body fat?
Are you NOT pregnant, breastfeeding, or planning to become pregnant soon?
Have you NOT had type 1 or type 2 diabetes?
Have you NOT lost 5% or more of your weight in the last 3 months?
Do you NOT have serious heart, lung, kidney, or hormone conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine (NNC0487-0111) or a placebo (a dummy treatment). You won't know which one you're getting, and this is decided randomly. The medication will be given as an injection once a week under the skin in your stomach area. You will have regular visits to the clinic for check-ups, where the study team will monitor your health, measure your food intake and appetite, and perform other tests to see how your body is responding to the treatment. These assessments will help the researchers understand the effects of the medicine. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you by the study team.

Potential risks and benefits

Taking part in a clinical study could offer potential benefits, such as contributing to scientific knowledge that may help develop new treatments for obesity in the future, and you'll receive careful medical monitoring throughout the study. However, there are also potential risks; for example, the new medicine might cause side effects, and some participants may not experience any direct health benefits. You will receive detailed information about all known or possible side effects before you decide to join. Remember, taking part is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Parexel International GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What does 'Phase 1' mean?

Phase 1 means this is one of the first times this new medicine is being tested in people. It mainly checks the safety of the medicine and how it works in the body.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual medicine.

How will the medicine be given?

The medicine, or placebo, will be given as a simple injection once a week under the skin of your stomach.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know which one you're receiving. This is decided by chance and is important for the study to be fair and accurate.

What kind of health checks will I have?

You'll have regular medical exams, blood tests, and vital sign checks to monitor your health and how you're responding to the treatment.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.