AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
The AMAZE 6 study is for adults who are overweight or have obesity and suffer from knee osteoarthritis, which is wear and tear in the knee joint. Researchers want to find out how well a new medicine, NNC0487-0111, works to help people lose weight and reduce their knee pain. They'll compare it to a 'placebo', which looks identical but contains no active medicine. Participants will receive weekly injections under the skin. The study will carefully check the safety of the new medicine and how effective it is. By finding new and better ways to manage weight and knee pain, this study hopes to improve the quality of life for people living with these conditions.
At a glance
What is this study about?
This study is called AMAZE 6 and it's looking into a new medicine for people who are overweight or have obesity and also experience knee pain due to osteoarthritis. Osteoarthritis is a common condition where the cartilage that cushions your joints wears down, causing pain and stiffness, especially in the knees. The new medicine being tested is called NNC0487-0111.
The main goal of this study is to see if NNC0487-0111 can help people with these conditions lose weight and feel less pain in their knees. To do this, some participants will receive the new medicine, while others will receive a 'placebo'. A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This helps researchers fairly compare the effects of the new medicine. Participants won't know which one they are getting, and neither will the study team, until the end of the study. This is a common and important way to make sure the results are as accurate as possible. Everything is decided by chance.
This kind of study, known as a Phase 3 trial, is a very important step. It's done after earlier studies have shown the medicine to be promising and safe, but before it could potentially be approved for wider use. The findings from AMAZE 6 will help us understand more about managing both excess body weight and knee problems, which could lead to better treatment options in the future.
Key takeaways
- This study is for adults with excess weight and knee arthritis pain.
- It tests a new medicine (NNC0487-0111) against a dummy medicine (placebo).
- The medicine is given as a weekly injection under the skin.
- The main goals are to see if the medicine helps with weight loss and reducing knee pain.
- Participants will have regular health checks and assessments.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and have a diagnosis of knee osteoarthritis confirmed by a doctor and X-rays. You should also be experiencing knee pain for most days over the last month, and this pain should have started at least three months ago. You'll need to be willing to temporarily stop taking most pain relief medicines before study visits where your pain levels are checked, though paracetamol (up to 4 grams a day) is usually allowed until 24 hours before these specific check-ups.
There are also some reasons why you might not be able to take part. For example, if you have certain levels of sugar in your blood which could suggest diabetes, or if you've been diagnosed with type 1 or type 2 diabetes. You also can't join if you've previously taken certain diabetes or weight-loss medicines that are similar to the study medicine. Additionally, if you've had knee surgery like a joint replacement, or injections into your knee, or even keyhole surgery (arthroscopy) in the last three months, or if you have other knee joint conditions like gout, 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 18 years old or older?
- Have you been diagnosed with knee osteoarthritis by a doctor, supported by X-rays?
- Do you experience knee pain most days, and it started at least 3 months ago?
- Have you NOT had knee surgery (like joint replacement or keyhole surgery) or injections into your knee in the last 3 months?
- Do you NOT have diabetes or certain high blood sugar levels (as confirmed by a recent blood test)?
What does participation involve?
If you decide to take part in this study, you will be given a study medicine as an injection under your skin once a week. You'll either receive the new medicine, NNC0487-0111, or a placebo (a dummy medicine). Which one you receive will be chosen randomly, like flipping a coin. You will have regular visits to the study clinic where the team will check your health, assess your knee pain, and monitor your weight. They will also take blood samples and perform other tests to see how the medicine is affecting you. The study involves a number of follow-up appointments over a period of time, though the exact total duration isn't specified in this overview. The study team will explain the full schedule of visits and what each visit involves before you make any decisions.
Potential risks and benefits
Locations (81)
- Neighborhood HealthcareVerified postcodeEscondido, United States· Recruiting
- First Valley Medical GroupVerified postcodeLancaster, United States· Recruiting
- Desert Oasis HealthcareVerified postcodePalm Springs, United States· Recruiting
- Chase Medical Research LLCVerified postcodeWaterbury, United States· Recruiting
- Westside Center For Clinical ResearchVerified postcodeJacksonville, United States· Recruiting
- CNS HealthcareVerified postcodeJacksonville, United States· Recruiting
- Advanced Res for Health ImproveVerified postcodeNaples, United States· Recruiting
- Clinical Investigation Spec GurneeVerified postcodeGurnee, United States· Recruiting
- Evanston Premier Hlthcr ResVerified postcodeSkokie, United States· Recruiting
- Monroe Biomedical Research, LLCVerified postcodeLouisville, United States· Recruiting
- Arcturus Healthcare, PLC.Verified postcodeTroy, United States· Recruiting
- Clinvest ResearchVerified postcodeSpringfield, United States· Recruiting
Common questions
What is osteoarthritis?
Osteoarthritis is a condition where the protective cartilage on the ends of your bones wears down over time, causing pain, swelling, and stiffness, especially in joints like the knee.
What is a 'placebo'?
A placebo is a substance or treatment that looks exactly like the real medicine but has no active ingredients. It's used in studies to help researchers compare the effects of the actual medicine fairly.
Will I know if I'm getting the real medicine?
No, during the study, neither you nor the study doctors will know if you are receiving the real medicine or the placebo. This is to ensure the results are unbiased.
Is this medicine approved for general use?
No, NNC0487-0111 is an investigational medicine, meaning it is still being studied and is not yet approved for use outside of clinical trials.
What if I want to stop participating?
You are free to leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
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