RecruitingPHASE3INTERVENTIONAL

AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

The AMAZE 4 study is exploring a new medicine called NNC0487-0111. It's for adults who are overweight or obese and also have a condition called obstructive sleep apnoea. People with obstructive sleep apnoea often use a special machine (like a CPAP machine) to help them breathe while they sleep. Researchers want to see if NNC0487-0111 can help people lose weight and improve their sleep apnoea. Participants in this study will receive weekly injections under the skin. Some will get the new medicine, while others will get a placebo (a 'dummy' injection with no active medicine). The medicine they receive is chosen randomly, like flipping a coin. The study will also check how safe the medicine is.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

300

Start

05 May 2026

Estimated completion

21 Aug 2028

Obesity Overweight Obstructive Sleep Apnoea

What is this study about?

Many people struggle with being overweight or obese, and this can sometimes lead to other health issues, including obstructive sleep apnoea. Obstructive sleep apnoea (OSA) is a condition where your breathing repeatedly stops and starts while you sleep, which can leave you feeling tired and affect your overall health. Often, people with OSA use a machine called Positive Airway Pressure (PAP) to help them breathe better at night.

This study, called AMAZE 4, is testing a new investigational medicine named NNC0487-0111. The main goal is to find out if this medicine can help people who are overweight or obese and also have obstructive sleep apnoea (and are already using PAP therapy). We want to see if it helps them lose weight and improves their sleep apnoea symptoms.

The research will also look closely at the safety of NNC0487-0111. During the study, participants will be given either the active medicine or a placebo, which looks identical but contains no medicine. This helps researchers understand the true effects of the new medicine. Finding new ways to manage weight and improve sleep apnoea could make a big difference to people's health and quality of life.

Key takeaways

This study is for adults who are overweight or obese and have obstructive sleep apnoea.
It tests a new medicine, NNC0487-0111, given as weekly injections.
The goal is to see if the medicine helps with weight loss and improves sleep apnoea.
You might receive the active medicine or a placebo (dummy medicine).
You'll need regular clinic visits and health checks.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You must have been diagnosed with moderate-to-severe obstructive sleep apnoea by a doctor, meaning your breathing stops and starts quite a lot during sleep. You also need to be considered overweight or obese.

There are some reasons why you might not be able to join. For example, if you have certain levels of a sugar marker in your blood (called HbA1c) that are too high, or if you have a history of type 1 or type 2 diabetes. You also can't have had any recent surgeries for sleep apnoea (within the last 3 months).

Finally, if you have certain facial or head conditions that affect breathing, or if you've previously taken specific types of weight-loss medicines (like GLP-1 related medicines or amylin analogues), you wouldn't be able to participate.

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 moderate-to-severe obstructive sleep apnoea?
Are you considered overweight or obese?
Do you currently use a machine like CPAP for your sleep apnoea?
Have you ever had type 1 or type 2 diabetes?
Have you used certain weight-loss medicines (like GLP-1 medicines) before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive weekly injections under your skin. These injections will either be the new medicine, NNC0487-0111, or a placebo (a dummy injection with no active medicine). Which one you get is decided by chance, like a lottery. You wouldn't know which one you're receiving.

Throughout the study, you would have regular visits to the clinic for various health checks and assessments. These might include blood tests, checking your weight, blood pressure, and sleep studies, to see how you are responding to the treatment. You would also be asked to keep using your existing Positive Airway Pressure (PAP) therapy for your sleep apnoea as usual. The study is quite long-term, lasting for a period of time that allows us to properly observe the effects of the medicine.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new investigational medicine that could help with weight loss and sleep apnoea. However, there's also a chance you might receive the placebo, which has no active medicine. Like all medicines, NNC0487-0111 could have side effects, and the research team will explain these to you fully before you decide to join. Your health and safety are the top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (91)

Dignity Health, Mercy Gilbert
Verified postcode
Gilbert, United States· Recruiting
DM Clinical
Verified postcode
Bradenton, United States· Recruiting
Essence MD Research
Verified postcode
Naples, United States· Recruiting
Palm Beach Research Center
Verified postcode
West Palm Beach, United States· Recruiting
NeuroTrials Research, Inc.
Verified postcode
Atlanta, United States· Recruiting
Physicians Research Associates
Verified postcode
Lawrenceville, United States· Recruiting
Chicago Research Center, Inc
Verified postcode
Chicago, United States· Recruiting
Weil Cornell Medicine
Verified postcode
New York, United States· Not yet recruiting
Lillestol Research LLC
Verified postcode
Fargo, United States· Recruiting
CTI Clinical Research Center
Verified postcode
Cincinnati, United States· Recruiting
Clinical Research Associates of Central PA, LLC
Verified postcode
DuBois, United States· Not yet recruiting
Bogan Sleep Consultants, LLC
Verified postcode
Columbia, United States· Recruiting

Common questions

What is obstructive sleep apnoea (OSA)?

OSA is when your breathing repeatedly pauses or becomes very shallow while you sleep, often causing you to snore loudly and feel tired during the day.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps us see if the new medicine really works better than no treatment at all.

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

No, neither you nor your study doctor will know which treatment you are receiving until the study has finished. This is to ensure fair and unbiased results.

How is the medicine given?

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

Can I continue my current sleep apnoea treatment?

Yes, you are expected to continue using your current Positive Airway Pressure (PAP) therapy for your sleep apnoea throughout the 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.