What side effects are associated with this type of intervention?

Common treatments for sleep apnea include CPAP therapy, weight loss medications, and surgical interventions. For treatments similar to Tirzepatide, which is a dual GIP and GLP-1 receptor agonist, the known side effects primarily include gastrointestinal symptoms such as nausea and vomiting. Other potential side effects can include pancreatitis, thyroid cancer, and gastrointestinal discomfort. These treatments are also associated with weight loss, which can be beneficial for managing sleep apnea.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of sleep apnea using GLP-1 receptor agonists or dual GIP and GLP-1 receptor agonists like Tirzepatide. Current treatments for sleep apnea typically involve lifestyle changes, CPAP therapy, and other mechanical interventions rather than pharmacological treatments. Tirzepatide is being studied for its potential effects on sleep apnea, particularly in patients with obesity, but it has not yet received FDA approval for this indication.

What other types of research exist?

A promising novel alternative to Tirzepatide for sleep apnea patients is the GLP-1/GCG/gastrin tri-agonist. This therapy has shown significant and sustained improvements in glucose tolerance and control, which can be beneficial for patients with obesity and diabetes, conditions often associated with sleep apnea.

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Tirzepatide for Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For GPI2 Participants: Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study

Be older than 18 years old

Must not have

For GPI1 and GPI2 Participants: Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration

For GPI1 and GPI2 Participants: Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing tirzepatide to see if it helps people with sleep apnea and obesity, especially those who can't or won't use certain therapies, as well as those who will continue using them. The medication works by controlling blood sugar and appetite, which might help with weight loss.

Who is the study for?

This trial is for adults with obstructive sleep apnea and obesity who either can't or won't use PAP therapy, or are currently using it and plan to continue. Participants must have a BMI of ≥30 kg/m², an AHI ≥15 on screening tests, and at least one failed diet attempt to lose weight. Pregnant women, individuals with certain types of diabetes or respiratory conditions that could affect the study's results are excluded.

What is being tested?

The study is testing Tirzepatide's effectiveness and safety in two groups: those not using PAP therapy (GPI1) and those continuing its use (GPI2). It aims to see if this medication can help manage sleep apnea symptoms in obese patients. The comparison will be made against a placebo.

What are the potential side effects?

While specific side effects for Tirzepatide in this context aren't detailed here, common ones may include digestive issues like nausea or diarrhea, potential allergic reactions, changes in appetite, fatigue, and possibly injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on PAP therapy for 3 months and will continue during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a significant amount of central or mixed sleep apnea.

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I have had or plan to have surgery for sleep apnea or major ENT surgery that could affect my breathing.

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I have type 1 or type 2 diabetes, or I've had ketoacidosis or a hyperosmolar coma.

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I have been diagnosed with Obesity Hypoventilation Syndrome or have high carbon dioxide levels during the day.

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I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed.

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I have face or skull shape issues affecting my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tirzepatide Maximum Tolerated DoseExperimental Treatment1 Intervention

Participants will receive a low dose and then increase to a maximum tolerated dose 1 or dose 2 subcutaneously (SC). GPI1: Participants are unwilling or unable to use PAP therapy. GPI2: Participants are on PAP therapy.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo SC GPI1: Participants are unwilling or unable to use PAP therapy. GPI2: Participants are on PAP therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sleep Apnea include Continuous Positive Airway Pressure (CPAP) therapy, weight loss interventions, and pharmacological treatments like GLP-1 receptor agonists. CPAP therapy works by keeping the airway open using a steady stream of air, preventing airway collapse during sleep. Weight loss interventions, including lifestyle changes and medications like GLP-1 receptor agonists, reduce fat deposits around the neck and improve airway patency. Tirzepatide, a dual GIP and GLP-1 receptor agonist, not only aids in weight loss but also improves glycemic control, which can reduce the severity of Sleep Apnea. These mechanisms are crucial as they directly address the airway obstruction and metabolic factors contributing to Sleep Apnea, improving sleep quality and reducing associated health risks.