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
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.
- Are you 18 years old or older?
- Do you have excess body weight?
- Have you *never* been diagnosed with type 1 or type 2 diabetes?
- Have you *not* used medicines like GLP-1 receptor agonists (e.g., Ozempic, Wegovy) or similar drugs in the past?
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
Locations (72)
- Pinnacle Research Group LLCVerified postcodeAnniston, United States· Recruiting
- Diablo Clinical Research, Inc.Verified postcodeWalnut Creek, United States· Recruiting
- Florida Inst For Clin Res LLCVerified postcodeOrlando, United States· Recruiting
- Endeavor HealthVerified postcodeSkokie, United States· Not yet recruiting
- Midwest Inst For Clin ResVerified postcodeIndianapolis, United States· Recruiting
- Medication Mgmnt, LLC_GrnsboroVerified postcodeGreensboro, United States· Recruiting
- PMG Research of Wilmington LLCVerified postcodeWilmington, United States· Recruiting
- UPA Ctr Weight and Eating DisVerified postcodePhiladelphia, United States· Recruiting
- Clinical Res CollaborativeVerified postcodeCumberland, United States· Recruiting
- North Texas Endocrine CenterVerified postcodeDallas, United States· Not yet recruiting
- UT Southwestern Med CntrVerified postcodeDallas, United States· Recruiting
- Selma Medical AssociatesVerified postcodeWinchester, 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?
Discussion
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