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A study evaluating the use of semaglutide for treating obstructive sleep apnea in older adults who are overweight or have obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate different ways to manage obstructive sleep apnea, a condition where breathing repeatedly stops and starts during sleep. The research focuses on older adults who are also living with overweight or obesity. Participants may receive semaglutide, which is administered through a subcutaneous injection, meaning the medicine is injected into the fatty layer of skin just under the surface. Some individuals might receive a placebo instead of the active medication.

During the study, researchers will monitor various health factors over a period of time. This includes tracking changes in the apnea-hypopnea index, which is a measure used to determine the severity of breathing interruptions during sleep. Other aspects being observed include daytime sleepiness, blood pressure, and changes in body weight. The study also looks at how the condition affects quality of life, sleep quality, and cognitive function, which refers to mental abilities such as memory and thinking.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The trial begins upon entry into the study to evaluate treatments for obstructive sleep apnea, a condition where breathing repeatedly stops and starts during sleep.

  2. Step 2

    Medication administration

    An injection of wegovy, which contains the active substance semaglutide, is administered. the dosage is 0.34 mg via a subcutaneous injection, which means the medicine is injected into the fatty tissue just under the skin.

  3. Step 3

    Monitoring and follow-up

    The progress is monitored over a period of 6 months.

    The main focus is to measure changes in the apnea-hypopnea index (ahi), which is a score used to determine the severity of sleep apnea by counting how many times breathing is interrupted during sleep.

    Additional information collected includes body weight, blood pressure, daytime sleepiness, sleep quality, and cognitive function, which refers to mental processes like memory and thinking.

Who can join the trial?

6 criteria

  • You must be 65 years of age or older.
  • You must have been diagnosed with moderate-to-severe obstructive sleep apnea, which is a condition where your breathing repeatedly stops and starts while you sleep.
  • Your sleep apnea must be measured by an apnea-hypopnea index (AHI) of 15 or more events per hour, which is a score that counts how many times your breathing becomes shallow or stops every hour.
  • Your sleep apnea must have been confirmed through a home-based sleep apnea test.
  • You must have a medical need for active treatment for your sleep apnea based on official medical guidelines.
  • You must be overweight or obese, which is measured by a body mass index (BMI) of 27 or higher. Body mass index (BMI) is a calculation used to estimate if a person has a healthy amount of body weight for their height.

Who cannot join the trial?

9 criteria

  • If you have or are suspected of having another sleep disorder, which is a condition that disrupts your normal sleep patterns.
  • If more than half of your breathing pauses during sleep are central apneas, which means your brain temporarily forgets to tell your body to breathe, or if you have Cheyne–Stokes respiration, a specific pattern of breathing that involves periods of deep breathing followed by periods of no breathing.
  • If you experience extreme sleepiness during the day, measured by a score of 18 or higher on the Epworth Sleepiness Scale, which is a questionnaire used to check how likely you are to fall asleep during daily activities.
  • If you are currently taking part in a weight-loss program.
  • If you are unable to follow the study instructions or attend the required check-ups.
  • If you have Type 1 or Type 2 diabetes, which are conditions involving high blood sugar levels.
  • If you have a serious long-term illness, such as neoplasia (cancer or abnormal growths), renal failure (kidney failure), severe COPD (a serious lung disease that makes it hard to breathe), or chronic depression (a long-lasting feeling of sadness).
  • If your living situation or location makes it difficult to follow the study rules.
  • If your doctor believes you must use CPAP (a machine that uses air pressure to keep your airways open while you sleep) as a necessary treatment.
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Investigated drugs

Semaglutide is a medication given through a small injection under the skin. It is used in this study to help manage weight, which is a key factor in treating obstructive sleep apnea.

What is already known about the treatment

Semaglutide - This medication is administered as a once-weekly injection under the skin using a pre-filled pen. It is currently an established treatment used to help manage long-term weight control and reduce the risk of serious heart issues in adults. The drug works by mimicking a natural hormone in the body that signals the brain to feel full and slows down digestion. It belongs to a group of medicines known as GLP-1 receptor agonists.

Investigated diseases

Obstructive sleep apnea - This condition occurs when the muscles in the throat relax too much during sleep, causing the airway to narrow or close completely. This blockage prevents normal breathing and leads to repeated pauses in breath throughout the night. As the disease progresses, these interruptions can become more frequent and severe. The irregular breathing patterns often lead to frequent awakenings that disrupt the sleep cycle. Over time, the repeated lack of oxygen during these episodes can affect various bodily functions.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-524819-37-00Protocol codeRAPHAELEstimated enrolment345 patientsSponsorInstitut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).