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Study on the Effectiveness of Orforglipron for Patients with Obstructive Sleep Apnea and Obesity or Overweight

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Orforglipron in individuals who have Obstructive Sleep Apnea (OSA) and are either overweight or have obesity. The study aims to determine if Orforglipron, taken as a capsule once daily, is more effective than a placebo in improving the condition of participants. Obstructive Sleep Apnea is a condition where breathing repeatedly stops and starts during sleep, often due to a blocked airway. Being overweight or having obesity can increase the risk of developing OSA.

The purpose of the study is to demonstrate that Orforglipron is superior to placebo in changing the Apnea-Hypopnea Index (AHI), which measures the severity of sleep apnea. Participants in the study will be randomly assigned to receive either Orforglipron or a placebo. The study will be conducted over a period of time, with participants taking the medication daily and attending regular check-ups to monitor their progress. The study will include individuals who either cannot or do not want to use Positive Airway Pressure (PAP) therapy, as well as those who are already using PAP therapy.

Throughout the study, participants will be monitored to assess changes in their Apnea-Hypopnea Index from the beginning of the study to the end, which is expected to last up to 52 weeks. The trial will help researchers understand the potential benefits of Orforglipron for people with Obstructive Sleep Apnea and weight-related issues, providing valuable insights into its safety and effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening
The initial phase involves a screening process to determine eligibility for the trial. This includes a test called a polysomnography (PSG) to measure the Apnea-Hypopnea Index (AHI). The AHI must be 15 or higher.
Participants must have a body mass index (BMI) of 27 kg/m² or more.
Step 2
Randomization
Eligible participants are randomly assigned to receive either the study medication, orforglipron, or a placebo that looks like the medication but has no active ingredients.
The trial is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo.
Step 3
Medication administration
Participants take the assigned capsule orally once daily. The duration of this phase is up to 52 weeks.
The goal is to assess the change in the Apnea-Hypopnea Index (AHI) from the start of the trial to the end of the 52-week period.
Step 4
Follow-up assessments
Throughout the trial, regular assessments are conducted to monitor the participant's health and the effectiveness of the treatment.
These assessments include measuring changes in the Apnea-Hypopnea Index (AHI) and other health indicators.
Step 5
Completion
At the end of the 52-week period, participants complete the trial.
Final assessments are conducted to evaluate the overall impact of the treatment on obstructive sleep apnea and related conditions.

Who can join the trial?

9 criteria

Must have **OSA (Obstructive Sleep Apnea)**, a condition where breathing stops and starts during sleep.
Must be **overweight or obese**, which means having a higher body weight than is considered healthy for a certain height.
Must have an **Apnea-Hypopnea Index (AHI)** of 15 or more. AHI measures the number of times breathing stops or becomes very shallow per hour of sleep.
Must have a **Body Mass Index (BMI)** of 27 kg/m² or more. BMI is a number calculated from a person's weight and height.
Must be unable or unwilling to use **PAP therapy**. PAP therapy is a treatment that uses mild air pressure to keep the airways open during sleep.
Must not have used PAP therapy for at least 4 weeks before the screening.
Must have been on PAP therapy for at least 3 consecutive months before the study starts and plan to continue using it during the study.
Both **male and female** participants are eligible.
Participants from **vulnerable populations** are included. This means people who might need special protection or care.

Who cannot join the trial?

6 criteria

Individuals who do not have OSA (Obstructive Sleep Apnea), a condition where breathing stops and starts during sleep.
Individuals who are not overweight or do not have obesity, which means having excess body weight or fat.
Individuals who are not within the specified age range for the study.
Individuals who are not part of the specified clinical trial groups.
Individuals who are not male or female, as both genders are included in the study.
Individuals who are not considered part of a vulnerable population, which means groups that may need special protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Institut fuer Diabetesforschung Muenster GmbH
Munster, Germany
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Milan Kvapil s.r.o.
Prague, Czechia
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Praglandia s.r.o.
Prague, Czechia

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Investigated drugs

Orforglipron is a medication being studied for its potential to help people with obstructive sleep apnea who are also dealing with obesity or are overweight. The trial aims to see if taking orforglipron once a day can improve the condition by reducing the number of times breathing stops or becomes very shallow during sleep, which is measured by the Apnea-Hypopnea Index (AHI).

3-((1S,2S)-1-(5-((S)-2,2-Dimethyltetrahydro-2H-Pyran-4-Yl)-2-((S)-3-(3-(4-Fluoro-1-Methyl-1H-Indazol-5-Yl)-2-Oxo-2,3-Dihydro-1H-Imidazol-1-Yl)-2-(4-Fluoro-3,5-Dimethylphenyl)-4-Methyl-4,5,6,7-Tetrahydro-2H-Pyrazolo[4,3-C]Pyridine-5-Carbonyl)-1H-Indol-1-Yl)-2-Methylcyclopropyl)-5-Oxo-1,2,4-Oxadiazol-4-Ide Hemicalcium

What is already known about the treatment

Orforglipron – This medication is administered orally in the form of a tablet taken once daily. It is currently being studied in clinical trials to assess its effectiveness and safety for individuals with obstructive sleep apnea and those who are overweight or obese. The main therapeutic indication is to improve breathing patterns during sleep by reducing the Apnea-Hypopnea Index, which measures the severity of sleep apnea. Orforglipron works by targeting specific receptors in the body to help regulate metabolic processes and improve respiratory function. It is classified as a medication that influences metabolic pathways, potentially aiding in weight management and respiratory health.

Investigated diseases

Obstructive Sleep Apnea
This condition is characterized by repeated episodes of partial or complete blockage of the upper airway during sleep. These blockages lead to breathing pauses, often followed by brief awakenings to restore normal breathing. The condition can cause loud snoring, daytime sleepiness, and fatigue due to disrupted sleep patterns. Over time, it may contribute to other health issues, such as high blood pressure and heart problems. The severity of the condition can vary, with some individuals experiencing mild symptoms and others facing more frequent and severe interruptions in breathing.
Overweight or Obesity
This condition involves having excess body fat that may impair health. It is typically measured using the Body Mass Index (BMI), which considers weight in relation to height. Overweight and obesity develop when calorie intake exceeds the amount of energy expended over time. This imbalance can lead to an accumulation of fat tissue, affecting various bodily functions. The condition can increase the risk of developing other health issues, such as type 2 diabetes, heart disease, and joint problems. It often requires lifestyle changes to manage and reduce health risks associated with excess weight.