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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 week 52
Awards & highlights

Summary

This trial is testing a new sleep apnea and obesity treatment for those who cannot or will not use PAP therapy.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Apnea-Hypopnea Index (AHI)
Secondary outcome measures
Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
+5 more

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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

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
~5560

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.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,641 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
416,007 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05412004 — Phase 3
Sleep Apnea Research Study Groups: Tirzepatide Maximum Tolerated Dose, Placebo
Sleep Apnea Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05412004 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412004 — Phase 3
Sleep Apnea Patient Testimony for trial: Trial Name: NCT05412004 — Phase 3
~156 spots leftby Jul 2025