J5P-MC-GZRA: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (ATTAIN-OSA); J5P-MC-GZ01: Participants with OSA unable or unwilling to use PAP therapy; J5P-MC-GZ02: Participants with OSA on PAP therapy
Obstructive sleep apnoea (OSA) causes your breathing to stop and start while you sleep, and carrying extra weight often makes it worse. This clinical trial is testing a new once-daily tablet called orforglipron to see if it can improve night-time breathing in adults who are overweight or living with obesity. The study looks at two groups of people with sleep apnoea: those who use a positive airway pressure (CPAP) breathing machine, and those who cannot or choose not to use one. Half of the participants will take the study tablet for 52 weeks, while the other half will take a dummy pill (placebo) with no active medicine. Neither you nor the trial doctors will know which one you receive. Researchers will track changes in your breathing during sleep and monitor your overall health and safety.
At a glance
What is this study about?
Obstructive sleep apnoea is a common condition where the walls of the throat relax and narrow during sleep, interrupting normal breathing. Carrying excess body weight is a major cause of sleep apnoea, as tissue around the neck can put extra pressure on your airways. The usual treatment is a night-time breathing machine known as CPAP, but many people find the mask uncomfortable or hard to sleep with.
This trial is investigating whether a new medicine called orforglipron can help. Orforglipron is a daily tablet designed to support weight reduction and metabolic health. By helping people lose weight, researchers hope it will also relieve pressure on the airways and reduce how often breathing stops during the night.
The study is divided into two parts to help as many people as possible: one group for people who currently use breathing machines, and another for people who are unable or unwilling to use them. Over the course of a year, the trial team will measure how much your sleep apnoea improves and whether the medicine is safe and easy to take.
Key takeaways
- Tests a once-daily tablet called orforglipron for obstructive sleep apnoea and weight management.
- Open to adults aged 18 and over who are living with excess body weight.
- Welcomes people who use CPAP machines as well as those who cannot use them.
- Lasts for 52 weeks (one year) with regular clinic visits and sleep monitoring.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with obstructive sleep apnoea and carry excess body weight (classified as overweight or living with obesity).
You may be able to join whether you currently use a night-time breathing machine (such as CPAP) or not. One part of the trial is specifically designed for people who cannot get on with these machines or prefer not to use them.
To ensure your safety, the medical team will review your general health. People with certain serious medical conditions, or those taking specific medications that could clash with the study drug, may not be able to take part.
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.
- I am aged 18 or older.
- I have been diagnosed with obstructive sleep apnoea.
- I am currently carrying extra weight (overweight or obese).
- I either use a CPAP machine regularly or find it difficult to use one.
- I am willing to attend regular hospital check-ups and undergo sleep tests for a year.
What does participation involve?
If you decide to take part, you will be in the study for about 52 weeks (one year). You will be randomly assigned by a computer to take either the study medicine or a dummy pill (placebo) once a day. You will need to attend regular clinic appointments so the medical team can check your health, take blood tests, and track your weight. You will also have sleep tests to see how often your breathing pauses at night. The research team will monitor you closely throughout the trial, and you will have follow-up visits to ensure you stay well after the treatment ends.
Potential risks and benefits
Locations (2)
- —UnverifiedCzechia
- —UnverifiedGermany
Common questions
What is obstructive sleep apnoea?
It is a condition where your airway temporarily closes while you sleep, causing your breathing to pause repeatedly. This often leads to loud snoring and daytime tiredness.
What is a placebo?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers prove whether the study drug really works.
Do I have to stop using my CPAP machine to take part?
No. The trial has a specific group for people who continue using their CPAP machine as normal throughout the study.
Will taking part cost me anything?
No, the study medication, tests, and medical visits are provided free of charge, and trial organisers often help cover reasonable travel expenses.
Can I leave the trial if I change my mind?
Yes, you are free to stop taking part at any time. Your decision will not change how your regular doctors treat you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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