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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
SURMOUNT-OSA Trial 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.
SURMOUNT-OSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on PAP therapy for 3 months and will continue during the study.
SURMOUNT-OSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score
Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
+5 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
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
SURMOUNT-OSA 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
~7590
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,589 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,783 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried to lose weight through dieting before but it didn't work.I have been diagnosed with a significant amount of central or mixed sleep apnea.I am willing to stop my current OSA treatment, other than PAP, for the study.Both groups of participants need to have a breathing problem during sleep, measured by a sleep test, with a score of at least 15.I have not used PAP therapy for at least 4 weeks.I have had or plan to have surgery for sleep apnea or major ENT surgery that could affect my breathing.I have type 1 or type 2 diabetes, or I've had ketoacidosis or a hyperosmolar coma.I have been diagnosed with Obesity Hypoventilation Syndrome or have high carbon dioxide levels during the day.You have lost or gained more than 11 pounds in the last 3 months before the screening.I have not used PAP therapy for at least 4 weeks.I have been on PAP therapy for 3 months and will continue during the study.Your HbA1c level is higher than 6.5% (or 48 mmol/mol) at the beginning of the study.You have a body mass index (BMI) of 30 or higher.I have had or plan to have a procedure for weight loss or had a device removed in the last 6 months.I am unwilling to pause my PAP therapy for a week before sleep testing.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed.I have face or skull shape issues affecting my breathing.I have had or am planning to have weight loss surgery, not including liposuction or tummy tuck over a year ago.I have been using PAP therapy for over 3 months and will continue during the study.You have a certain level of sleep disorder, as shown by a sleep test.I do not have lung or muscle diseases that could affect the trial's results.You have tried and failed to lose weight through dieting at least once.You have a BMI of 30 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide Maximum Tolerated Dose
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Apnea Patient Testimony for trial: Trial Name: NCT05412004 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are taking part in this experiment?
"That is correct, the clinicaltrials.gov website currently has this trial listed as recruiting patients. The study was first posted on 6/21/2022 and was last edited on 11/10/2022. Up to 412 people are needed for the 20 different locations where the trial will be taking place."
Answered by AI
At how many different medical facilities can patients enroll in this clinical trial?
"A few of the 20 locations where this trial is enrolling patients are Sleep Therapy Research Center in San Antonio, Texas, Preferred Primary Care Physicians, and Preferred Clinical Research (Ofc 18) in Pittsburgh, Pennsylvania."
Answered by AI
Are participants being accepted for this clinical trial at present?
"The latest information available on clinicaltrials.gov suggests that this study is still recruiting patients. According to the posted data, which was last edited on 11/10/2022, the trial originally started on 6/21/2022 and is looking for a total of 412 participants at 20 different sites."
Answered by AI
When will Tirzepatide be available to the public?
"Tirzepatide's safety was scored a 3 by our team because it is in Phase 3 clinical trials. This indicates that, while there is data supporting its efficacy, tirzepatide has undergone multiple rounds of testing to confirm its safety."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
Ohio
Other
How old are they?
65+
18 - 65
What site did they apply to?
Artemis Institute for Clinical Research
FutureSearch Trials of Neurology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
Interested in weight loss and improving sleep. I have tried every diet program there is - including bariatric surgery. Nothing seems to really work.
PatientReceived 2+ prior treatments
I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before and I need help.
PatientReceived 2+ prior treatments
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