We are researching if a monthly GLP-1 RA study medicine can help improve symptoms of obstructive sleep apnea (OSA) in people living with overweight or obesity who are using a breathing machine (PAP therapy).
People living with overweight or obesity are more likely to experience obstructive sleep apnea (OSA). For people with obesity, a weight loss of 10% to 15% has been shown to reduce the symptoms of OSA by up to 50%.1, 2
If you decide to join the Vesper-OSA 1 study, your health and OSA symptoms will be carefully monitored. You will also receive guidance on diet, exercise, and lifestyle from a team of weight loss specialists and be given a variety of tools to support you every step of the way.
Who may participate
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. Some of the eligibility criteria to participate in this clinical trial include:
Obstructive sleep apnea
Diagnosed with OSA and are using a breathing machine called positive airway pressure (PAP) therapy
Overweight or obesity
Body mass index (BMI) of 27 or higher
Age
18+ years
Additional requirements apply
The study team will discuss other requirements with you and determine if you are eligible to participate in this clinical trial.
What to expect
Before you decide to join this clinical trial, the study team will perform some screening tests to see if the clinical trial is a good fit for you.
If you meet all the requirements, your participation will last about 63 weeks. You will be asked to complete an overnight sleep study to monitor your obstructive sleep apnea 3 times throughout the study.
During the Treatment Period, you will be randomly assigned (like pulling a number out of a hat) to receive either the study medicine or a placebo. The placebo looks like the study medicine but does not have any active ingredients in it. You will reach your target monthly dose through gradual dose escalation.
Both the study medicine and the placebo will be given as an injection under the skin. You, or a caregiver, will be instructed on how to give the injections at home.
After you finish the Treatment Period, you will have 2 additional follow-up visits.
Length of study treatment
52 weeks
Number of study visits
About 13 in-person visits and 4 telehealth visits
Study-related costs
No cost to participate, and health insurance is not required
About the study medicine
The study medicine is a GLP-1 RA (glucagon-like peptide-1 receptor agonist). It mimics the effects of a hormone in your body called GLP-1 that helps control your appetite and blood sugar. Along with a healthy diet and exercise, it may help people lose weight by:
- Increasing a feeling of fullness after eating
- Slowing down digestion
- Reducing appetite
- Regulating blood sugar levels
The study medicine is designed to be long acting, which may allow people to achieve their weight loss goals with only 1 dose per month once they reach their target dose.
Together we can make a difference
For many people, finding solutions to manage their weight and OSA symptoms can be a challenge. We are committed to advancing research that may expand weight management treatment options for people living with OSA and overweight or obesity.
Many factors—including age, overall health, lifestyle, and individual differences—can affect weight management and how a person responds to potential treatment. That’s why it’s important for this clinical trial to include participants from a wide range of backgrounds. This will help researchers better understand the study medicine and how it may work for different people.
Your participation and commitment could make a difference for people looking for treatment options to help manage their weight and improve their OSA symptoms.
About obstructive sleep apnea3-5
Obstructive sleep apnea (OSA) is a condition where your airway becomes blocked while you sleep. This happens when the muscles in your throat relax too much, causing your breathing to slow down or stop for short periods during sleep.
Weight is a major contributor to OSA. Excess weight in the body can increase pressure on different areas. Around the neck, it can narrow the airway and contribute to its collapse during sleep. In the chest, it can restrict lung capacity, making it difficult to breathe.
At the same time overweight or obesity is driving OSA, lack of sleep can drive additional weight gain by affecting the hormones that regulate hunger and appetite. Sleepiness during waking hours can limit the amount of energy you have for physical activities, making you too tired to exercise.
Weight loss has been shown to reduce the symptoms of OSA for people with overweight or obesity. Achieving and maintaining a healthy weight may not only help you sleep better, but it could reduce the risk of developing other long-term complications related to OSA.
Frequently asked questions
If you qualify and decide to participate, you will receive:
- All study-related visits, assessments, and the study medicine at no cost
- Reimbursement for study-related expenses, such as parking and other transportation costs
- Guidance on diet, exercise, and lifestyle from a team of weight loss specialists, and a variety of tools
The placebo looks like the study medicine but does not have any active ingredients in it. It is used so that researchers can see if there are differences in how people respond to the study medicine.
Whether you are in the placebo group or the study medicine group, you will be making a difference in our understanding of how the study medicine works.
Because the study medicine affects digestion, some people may experience side effects like nausea, vomiting, diarrhea, and/or constipation. The study team can advise on ways to manage or minimize these types of side effects, such as eating smaller meals, drinking plenty of fluids, and eating only when hungry.
There are other common side effects that the study team will explain before you join the study.
You will be required to continue using your PAP machine throughout the clinical trial.
The study team will work with you to develop a diet plan, including a reduced daily calorie intake goal, to help you lose weight in a healthy way.
They will also provide you with regular nutritional counseling to help you meet your weight loss goals.
You will be asked to complete at least 150 minutes of moderate exercise per week. A wide variety of resources will be available to help you plan your physical activities and keep you motivated.
Participation is completely voluntary. You can leave the clinical trial at any time and for any reason, without affecting your regular medical care or benefits.
References
- Stelmach-Mardas M, Brajer-Luftmann B, Kuśnierczak M, et al. Body mass index reduction and selected cardiometabolic risk factors in obstructive sleep apnea: meta-analysis. J Clin Med. 2021;10(7):1485. doi:10.3390/jcm10071485
- Peppard PE, Young T, Palta M, et al. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000;284:3015–3021. doi: 10.1001/jama.284.23.3015
- Fattal D, Hester S, Wendt L. Body weight and obstructive sleep apnea: a mathematical relationship between body mass index and apnea-hypopnea index in veterans. J Clin Sleep Med. 2022;18(12):2723-2729. doi:10.5664/jcsm.10190
- Schwartz AR, Patil SP, Laffan AM, et al. Obesity and obstructive sleep apnea: pathogenic mechanisms and therapeutic approaches. Proc Am Thorac Soc. 2008;5(2):185-192. doi:10.1513/pats.200708-137MG
- Shah NM, Kaltsakas G. Respiratory complications of obesity: from early changes to respiratory failure. Breathe (Sheff). 2023;19:22063. doi: 10.1183/20734735.0263-2022
