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RecruitingPHASE3INTERVENTIONAL

AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

This research study, called AMAZE 12, is looking for people aged 18 and over who have excess body weight. The main goal is to test a new medicine, NNC0487-0111, to see how well it helps individuals maintain their weight loss. Currently, there are two types of treatment being used in the study, NNC0487-0111, or a placebo, which is a dummy medicine with no active ingredients. Both treatments are given as injections under the skin once a week. The study will randomly decide which treatment each participant receives. This helps researchers understand if the new medicine is both safe and effective for helping people manage their weight.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Novo Nordisk A/S
Enrolment target
600
Start
21 Apr 2026
Estimated completion
04 Jul 2028

What is this study about?

This study, known as AMAZE 12, is exploring a new medicine called NNC0487-0111. It's designed for people who have been carrying extra weight and have successfully lost some of it, but now need help to keep that weight off. The researchers want to find out if this new medicine can be a safe and effective way to help people maintain a healthy weight in the long term.

To do this, some participants will receive the new medicine, NNC0487-0111, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This is a common and important part of clinical trials because it allows researchers to accurately compare the effects of the new medicine against no treatment. No one, not even the doctors or the patients, will know who is getting which treatment until the end of the study. This helps make sure the results are fair and unbiased.

The medicine, whether it's NNC0487-0111 or the placebo, is given as a weekly injection just under the skin. The study is in Phase 3, which means it has already gone through earlier stages of testing and has shown some promise. This phase is usually the final step before a medicine might be approved for wider use, if it proves to be safe and effective.

Key takeaways

  • This study is testing a new medicine (NNC0487-0111) for maintaining weight loss.
  • Participants will receive weekly injections of either the new medicine or a dummy medicine (placebo).
  • It's for adults aged 18 and over who have excess body weight.
  • People with diabetes or those who have taken certain prior weight-loss medicines cannot join.
  • The study aims to check if the new medicine is safe and effective.

Who may be eligible?

This study is looking for both men and women who are 18 years old or older. You will need to be in general good health, apart from having excess body weight.

You cannot take part if you have diabetes, either type 1 or type 2. This will be checked with a blood test. Also, if you have previously taken certain types of medicines for weight management, such as GLP-1 receptor agonists, you would not be able to join this study.

The research team will carry out some checks to make sure this study is suitable and safe for you. They will look at your overall health and medical history to see if you meet all the requirements.

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.

  1. Are you 18 years old or older?
  2. Do you have excess body weight?
  3. Have you *never* been diagnosed with type 1 or type 2 diabetes?
  4. Have you *not* used medicines like GLP-1 receptor agonists (e.g., Ozempic, Wegovy) or similar drugs in the past?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive regular injections under your skin once a week. You will either get the new medicine, NNC0487-0111, or a dummy medicine called a placebo – you won't know which one. You'll have regular visits to the clinic for health checks, to discuss how you're feeling, and to receive your treatment. These visits will involve various assessments, which could include blood tests, measuring your weight, and checking your vital signs. The study team will provide all the necessary details about how often you need to visit and what each visit will involve. The total duration of your participation in the study, including all treatments and follow-up, will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. You might benefit from receiving a new medicine before it's widely available, and your participation will contribute to medical knowledge that could help others in the future. However, there's no guarantee the study medicine will work for you, and you might experience side effects. The dummy medicine also means you might not receive an active drug. All possible risks and side effects will be fully explained by the study team, and 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.
  • Pinnacle Research Group LLC
    Verified postcode
    Anniston, United States· Recruiting
  • Diablo Clinical Research, Inc.
    Verified postcode
    Walnut Creek, United States· Recruiting
  • Florida Inst For Clin Res LLC
    Verified postcode
    Orlando, United States· Recruiting
  • Endeavor Health
    Verified postcode
    Skokie, United States· Not yet recruiting
  • Midwest Inst For Clin Res
    Verified postcode
    Indianapolis, United States· Recruiting
  • Medication Mgmnt, LLC_Grnsboro
    Verified postcode
    Greensboro, United States· Recruiting
  • PMG Research of Wilmington 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
  • North Texas Endocrine Center
    Verified postcode
    Dallas, United States· Not yet recruiting
  • UT Southwestern Med Cntr
    Verified postcode
    Dallas, United States· Recruiting
  • Selma Medical Associates
    Verified postcode
    Winchester, United States· Recruiting

Common questions

What is a 'placebo'?

A placebo is a dummy medicine that looks just like the real one but doesn’t contain any active ingredients. It helps researchers see if the real medicine is actually working.

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

No, neither you nor the study team will know which treatment you are receiving. This is to ensure the study results are fair and accurate.

How is the medicine given?

The medicine is given as an injection just under your skin, once a week.

What does 'excess body weight' mean in this study?

The study defines this in a specific way using health measurements. The research team will check if your current weight meets their criteria.

Can I leave the study early if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your normal healthcare.

How to find out more

Novo Nordisk

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

Interested in taking part?

Register your interest

Share your details and the research team for "AMAZE 12: A Research Study Investigating How Well the Medici…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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