A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
This research is testing a new medication, orforglipron, for people in the UK who have a condition called Obstructive Sleep Apnoea (OSA) and are also overweight or obese. OSA is when your breathing repeatedly stops and starts while you sleep. The study wants to see both how effective this new medication is and if it’s safe to use. It’s split into two groups: one for people who can't or choose not to use the usual CPAP breathing machine, and another for those who are already successfully using a CPAP machine and plan to continue. The aim is to find new ways to help manage OSA symptoms and weight.
At a glance
What is this study about?
This research project is investigating a new medicine called orforglipron. It's designed for people who have two common health conditions: Obstructive Sleep Apnoea (OSA) and being overweight or obese. OSA is a sleep disorder where your breathing repeatedly stops and starts, often due to a blockage in your airway, which can lead to poor sleep and other health problems. Being overweight or obese can increase the risk and severity of OSA.
The main goal of this study is to find out if orforglipron can help improve OSA symptoms and manage weight safely. The study is divided into two main parts. One part is for individuals with OSA who either can't use or choose not to use the standard treatment, which is a CPAP machine (a device that helps you breathe continuously during sleep). The other part is for those who are already successfully using a CPAP machine and plan to keep using it throughout the study. This setup helps the researchers understand how orforglipron works in different situations.
By taking part, you would be helping doctors and scientists learn more about new ways to treat OSA and manage weight. It's a chance to contribute to medical knowledge and potentially help future patients. The study is in its 'Phase 3', which means it's one of the last steps before a medicine might be made available to the public, if it's found to be safe and effective.
Key takeaways
- This study is for people with Obstructive Sleep Apnoea (OSA) and who are overweight or obese.
- It's testing a new medication called orforglipron.
- There are two groups: one for those not using CPAP, and one for those who are.
- Participants will receive either the new medication or a placebo.
- Regular health checks and study visits will be part of taking part.
- Your participation could help advance new treatments for OSA.
Who may be eligible?
To be considered for this study, you would need to be 18 years old or older, and have moderate to severe sleep apnoea. An important part of checking for sleep apnoea is a sleep test (polysomnography) where your breathing stops and starts at least 15 times per hour. You also need to be overweight or obese, which doctors often measure using something called Body Mass Index (BMI – a guide to whether your weight is healthy for your height), with your BMI being 27 or higher.
There are also some things that would mean you couldn't join. For example, if you have type 1 or type 2 diabetes, or if your blood sugar levels are too high. You also wouldn't be able to participate if you've had certain surgeries for sleep apnoea, or if you have other types of sleep apnoea like central or mixed sleep apnoea, or a condition called obesity hypoventilation syndrome. People who have had major recent weight changes, or who've had or plan to have weight-loss surgery or certain other weight-loss procedures, would also not be able to join.
For those who normally use a CPAP machine, you would need to have been using it regularly for at least three months. If you can’t safely stop your CPAP for a short period during the study, or you don't want to, you wouldn't be able to join the specific group that requires this.
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?
- Do you have a Body Mass Index (BMI) of 27 or higher (meaning you are overweight or obese)?
- Do you NOT have Type 1 or Type 2 diabetes?
- Have you NOT had any recent major weight changes (more than 5 kg) in the last three months?
- Are you NOT planning any weight-loss surgery or procedures?
What does participation involve?
If you decide to take part in this study, you would be given either the new medicine called orforglipron or a dummy medicine (placebo). Neither you nor your study doctor would know which one you are taking. You would have regular visits to the study clinic for check-ups and to see how you're getting on. These visits would involve various assessments, which might include having your sleep monitored, blood tests, and measurements of your weight and general health. You would take the study medication as directed by the research team. The total duration of your involvement in the study would be explained to you in detail by the study team, along with how often the visits would be. You would also have follow-up appointments after you finish taking the medication. Throughout the study, the team will monitor your health carefully. They will give you all the information you need about what is involved in taking part.
Potential risks and benefits
Locations (66)
- Ark Clinical ResearchVerified postcodeLong Beach, United States
- Peninsula Research AssociatesVerified postcodeRolling Hills Estates, United States
- Artemis Institute for Clinical ResearchVerified postcodeSan Diego, United States
- Care Access - AuroraVerified postcodeAurora, United States
- EBGS Clinical Research CenterVerified postcodeSnellville, United States
- Elite Clinical TrialsVerified postcodeBlackfoot, United States
- Care Access - ShreveportVerified postcodeShreveport, United States
- The Sleep Spot - MaimonidesVerified postcodeAlbuquerque, United States
- Accellacare - WilmingtonVerified postcodeWilmington, United States
- CTI Clinical Research CenterVerified postcodeCincinnati, United States
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Verified postcodePittsburgh, United States
- Preferred Primary Care PhysiciansVerified postcodeUniontown, United States
Common questions
What is Obstructive Sleep Apnoea (OSA)?
OSA is a common condition where your breathing repeatedly stops and starts for brief moments while you're asleep, often causing loud snoring, restless sleep, and daytime tiredness.
What is orforglipron?
Orforglipron is a new medication being tested in this study to see if it can help people with OSA and who are overweight or obese.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the study medication but contains no active ingredients. It helps researchers understand if the new medication is truly effective.
Will I have to stop using my CPAP machine?
If you currently use a CPAP machine, one part of the study is for people who continue using it. However, if you are able and willing, another part of the study is for those who do not use or have stopped using CPAP.
How long will the study last?
The study team will explain the exact duration of your involvement, including how often you'll need to visit the clinic and for how long you'll take the medication, during your initial consultation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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