RecruitingPHASE3INTERVENTIONAL

AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

The AMAZE 1 study is investigating a new medicine, NNC0487-0111, for people living with obesity. It aims to determine if this medicine is safe and effective in helping individuals lose excess body weight. Participants will receive either NNC0487-0111 or a placebo (a treatment with no active medicine) through weekly injections under the skin. The decision on which treatment a participant receives is made randomly. This type of research helps doctors understand how new medicines work and if they could become a treatment option in the future. It's a Phase 3 study, meaning it's one of the final stages of testing before a medicine might be approved for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

1,150

Start

24 Feb 2026

Estimated completion

21 Aug 2029

Obesity

What is this study about?

The AMAZE 1 study is looking into a new medicine called NNC0487-0111. The main goal is to find out if this medicine can safely and effectively help people who have excess body weight to lose it. Many people find it hard to lose weight and keep it off, even after trying diet changes. This study hopes to find new ways to support individuals on their weight loss journey.

In this study, some participants will receive injections of the new medicine, NNC0487-0111, while others will receive a 'placebo'. A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This is a common and important way to test new medicines fairly, ensuring that any effects seen are truly due to the medicine itself and not other factors. Which treatment you get is decided completely by chance, like flipping a coin.

Understanding if NNC0487-0111 is both safe and effective is crucial. If successful, this medicine could offer a new option for managing obesity, a condition that can lead to many health problems. By taking part in studies like AMAZE 1, volunteers play a vital role in advancing medical knowledge and potentially helping countless others in the future.

Key takeaways

Tests a new medicine (NNC0487-0111) for weight loss.
Involves weekly injections, either actual medicine or placebo.
Open to adults aged 18 and over with excess body weight.
Not suitable for individuals with diabetes or those who have used certain weight-loss drugs before.
Participation helps advance understanding of new obesity treatments.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over. You must also have tried to lose weight through diet at least once before, without success. Both men and women are welcome to take part.

There are also some things that would mean you couldn't join the study. For example, if you already have diabetes (either type 1 or type 2), or if a recent blood test shows your blood sugar levels are too high, you wouldn't be able to participate. This is because the study is specifically looking at people without existing diabetes.

Also, if you've previously used certain types of weight-loss medicines, like those that affect GLP-1 or GIP, or similar treatments, you wouldn't be eligible for this study. These rules help make sure the study results are clear and that participants are as safe as possible.

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 tried to lose weight with diet changes before, without lasting success?
Do you have excess body weight (obesity)?
Do you have diabetes (type 1 or type 2) or high blood sugar?
Have you used certain GLP-1 or similar weight-loss medicines previously?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the AMAZE 1 study, you would first have an initial screening visit to check if the study is right for you. If you qualify, you would then receive either the study medicine, NNC0487-0111, or a placebo, given as an injection under your skin once a week. You would have regular visits to the study clinic, where the research team would monitor your health and how you're responding to the treatment. These visits might include blood tests, physical examinations, and general discussions about your well-being. The full duration of the study, including the treatment period and any follow-up, would be fully explained to you before you agree to take part.

Potential risks and benefits

Taking part in a clinical study could offer potential benefits, such as contributing to scientific research that may help others with obesity in the future, and receiving regular medical check-ups and support from a dedicated research team. However, like all medicines, NNC0487-0111 may have side effects, which would be fully explained to you. You might also receive the placebo, meaning you wouldn’t get the active medicine. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

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

South Broward Research LLC
Verified postcode
Miramar, United States· Recruiting
Clinical Neuroscience Solution
Verified postcode
Orlando, United States· Recruiting
Hope Clin Res & Wellness
Verified postcode
Conyers, United States· Recruiting
Endeavor Health
Verified postcode
Skokie, United States· Recruiting
Midwest Inst For Clin Res
Verified postcode
Indianapolis, United States· Recruiting
StudyMetrix Research LLC
Verified postcode
City of Saint Peters, United States· Recruiting
New York Gastroenterology Associates
Verified postcode
New York, United States· Recruiting
UNC Eastowne Medical Office
Verified postcode
Chapel Hill, United States· Recruiting
PharmQuest Life Sciences LLC
Verified postcode
Greensboro, United States· Recruiting
Accellacare and KDCILM, LLC
Verified postcode
Wilmington, United States· Recruiting
UPA Ctr Weight and Eating Dis
Verified postcode
Philadelphia, United States· Recruiting
Clinical Res Collaborative
Verified postcode
Cumberland, United States· Recruiting

Common questions

What is the new medicine being tested?

The new medicine being tested is called NNC0487-0111 and it's for people with excess body weight (obesity).

How will the medicine be given?

The medicine will be given as an injection under the skin once a week.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active ingredients. It helps researchers compare the effects of the active medicine.

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

No, whether you receive the active medicine or the placebo is decided by chance, and neither you nor the study team will know which you are getting during the study.

Can I still participate if I have diabetes?

No, if you have type 1 or type 2 diabetes, or high blood sugar levels, you would not be able to join this study.

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.