RecruitingPHASE3INTERVENTIONAL

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Researchers are looking for adults, aged 18 to 99, to take part in a study testing a new medicine called Maridebart Cafraglutide. This medicine is for people who have obstructive sleep apnea (OSA), which means their breathing repeatedly stops and starts during sleep. You also need to be using a positive airway pressure (PAP) machine, like a CPAP, and be overweight or have obesity. The study wants to find out if this new medicine can help improve your sleep apnea symptoms and if it's safe to use over about a year (52 weeks). Half the people in the study will get the new medicine, and the other half will get a placebo (a dummy medicine with no active ingredients).

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

250

Start

19 Dec 2025

Estimated completion

13 Sep 2028

Obesity Obstructive Sleep Apnea

What is this study about?

This research study is about a new medicine called Maridebart Cafraglutide. It's being tested in adults who have a common sleep disorder called obstructive sleep apnea, often shortened to OSA. People with OSA find their breathing stops and starts repeatedly while they sleep because their airway becomes blocked. This can lead to poor sleep, tiredness during the day, and other health problems.

Many people with OSA already use a special machine, like a CPAP, to help them breathe better at night. This study is for those who use these machines and are also overweight or have obesity. The main goal is to see if adding this new medicine to their existing treatment can help improve their sleep apnea even more, and if it's safe to use over a long period, specifically 52 weeks (about a year).

If successful, this new medicine could offer another way to help people manage their obstructive sleep apnea, especially for those who are also dealing with overweight or obesity. It's an important step in finding more ways to help people get better rest and improve their overall health.

Key takeaways

This study is testing a new medicine for sleep apnea in adults.
Participants must use a PAP machine and be overweight or have obesity.
The study lasts about one year and involves regular clinic visits.
You might get the new medicine or a dummy medicine (placebo).
You'll have sleep tests, which may involve temporarily pausing PAP use.
It's important to discuss any concerns with the study team.

Who may be eligible?

To join this study, you need to be an adult between 18 and 99 years old. You must have been diagnosed with obstructive sleep apnea (OSA) and your sleep test results should show a certain number of breathing pauses or shallow breaths per hour. You also need to be overweight or have obesity, based on your Body Mass Index (BMI).

Crucially, you must already be using a PAP machine (like a CPAP) for your sleep apnea and have been using it regularly for at least three months. You should also plan to continue using it throughout the study. Interestingly, you also need to have tried to lose weight through diet and exercise at least once before, even if it wasn't successful.

There are also some reasons why you might not be able to join. For example, if you've had surgery for your sleep apnea, have certain breathing problems like central sleep apnea, or other serious health conditions, you might not be suitable. Also, if you use other devices for your sleep apnea besides a PAP machine, you might need to stop using them to join the study.

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 between 18 and 99 years old?
Have you been diagnosed with obstructive sleep apnea (OSA) and use a PAP machine?
Have you been using a PAP machine consistently for at least 3 months?
Are you overweight or have obesity (a BMI of 27 or more)?
Have you tried to lose weight through diet and exercise before?
Have you NOT had any surgery for sleep apnea or serious breathing problems like central sleep apnea?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 52 weeks, which is roughly one year. You'll be randomly assigned to either receive the new medicine, Maridebart Cafraglutide, or a placebo (a dummy medicine with no active ingredients). This decision is made by chance, like flipping a coin, and neither you nor the study team will know which you are receiving, to ensure fair results.

Throughout the study, you'll have regular visits to the clinic for health checks, to discuss any side effects, and to get your study medicine. You'll continue to use your PAP machine as usual. You'll also have some sleep tests (like polysomnography) at different times to see how your sleep apnea is changing. There will be a period during some of these tests where you might be asked to temporarily stop using your PAP machine for up to 7 days, to allow researchers to specifically measure the medicine's effect. The team will explain exactly what's involved at each step and how long each visit might take.

Potential risks and benefits

Participating in this study might offer potential benefits, such as potentially improving your sleep apnea symptoms with the new medicine. You'll also receive careful medical attention and monitoring throughout the study. However, there are potential risks, like experiencing side effects from the study medicine, which are not yet fully known. There's also no guarantee that the medicine will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (56)

Valley Clinical Trials
Verified postcode
Northridge, United States· Recruiting
Peninsula Research Associates
Verified postcode
Rolling Hills Estates, United States· Recruiting
Teradan Clinical Trials
Verified postcode
Brandon, United States· Recruiting
Destiny Research Center
Verified postcode
Palmetto Bay, United States· Recruiting
Clinical Research Center Of Florida
Verified postcode
Pompano Beach, United States· Recruiting
NeuroTrials Research
Verified postcode
Atlanta, United States· Recruiting
Basil Clinical
Verified postcode
Laurelton, United States· Recruiting
Monroe Biomedical Research
Verified postcode
Monroe, United States· Recruiting
CTI Clinical Research Center
Verified postcode
Cincinnati, United States· Recruiting
FutureSearch Trials of Neurology
Verified postcode
Austin, United States· Recruiting
Epic Medical Research - DeSoto
Verified postcode
DeSoto, United States· Recruiting
Sleep Therapy & Research Center
Verified postcode
San Antonio, United States· Recruiting

Common questions

What is Maridebart Cafraglutide?

It's a new medicine being tested in this study to see if it can help people with obstructive sleep apnea who also use a PAP machine and are overweight or have obesity.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real medicine but contains no active ingredients. It's used to compare against the real medicine to see if it's truly effective.

Do I have to stop using my CPAP machine?

You'll continue using your CPAP machine normally, but for some specific sleep tests during the study, you might be asked to stop using it for up to 7 days.

How long will the study last?

The study will last for about 52 weeks, which is roughly one year.

Can I leave the study at any time?

Yes, you have the right to stop participating in the study at any point, for any reason. Your medical care won't be affected if you choose to withdraw.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

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