Tirzepatide for Obstructive Sleep Apnea and Obesity

(SURMOUNT-OSA Trial)

No longer recruiting at 86 trial locations

Overseen By Mira Baron

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Pregnancy, Obesity surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tirzepatide (a GIP/GLP-1 receptor agonist) to determine its effectiveness for individuals with sleep problems and obesity. The focus is on those with moderate to severe obstructive sleep apnea who either cannot or choose not to use a special breathing machine (PAP therapy). The trial also includes individuals already using this machine to assess tirzepatide's effects on them. Suitable candidates for this trial have a BMI of 30 or higher and have unsuccessfully attempted weight loss through diet. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using any active device treatment for sleep apnea other than PAP therapy, you must be willing to stop it at baseline and throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally well-tolerated by people with moderate to severe obstructive sleep apnea and obesity. In earlier studies, most participants experienced mild to moderate side effects, with nausea, diarrhea, and decreased appetite being the most common.

For many, these side effects were temporary and improved over time. Notably, the FDA has already approved tirzepatide for other uses, indicating that its safety is well-understood.

Overall, while side effects can occur, they are usually manageable. This provides confidence in its safety for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for sleep apnea?

Tirzepatide is unique because it targets both obesity and obstructive sleep apnea (OSA) with a single treatment. Unlike current standard treatments for OSA, such as CPAP machines or surgical interventions, Tirzepatide is a medication that works by mimicking hormones involved in appetite and blood sugar regulation, potentially addressing the root cause of OSA related to obesity. Additionally, it's administered as a once-weekly subcutaneous injection, which can be more convenient compared to daily or nightly treatments. Researchers are excited because Tirzepatide could offer a dual benefit, reducing weight and improving sleep apnea symptoms, which is not typically achieved with existing OSA therapies.

What evidence suggests that tirzepatide might be an effective treatment for obstructive sleep apnea and obesity?

Research has shown that tirzepatide, which participants in this trial may receive, can help treat obstructive sleep apnea in people with obesity. In studies, it reduced the frequency of breathing interruptions during sleep. Participants also lost weight, which can improve sleep apnea. Additionally, those taking tirzepatide reported better sleep and increased daytime alertness. Overall, these findings suggest that tirzepatide may be a promising treatment for individuals managing both conditions. ^{2 5 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have tried to lose weight through dieting before but it didn't work.

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.

Exclusion Criteria

For GPI2 Participants: Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tirzepatide or placebo as a subcutaneous injection once weekly for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tirzepatide

Trial Overview 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.

How Is the Trial Designed?

Group I: Tirzepatide MTD_GPI2 Experimental Treatment 1 Intervention

Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks

Group II: Tirzepatide MTD_GPI1 Experimental Treatment 1 Intervention

Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks

Group III: Placebo_GPI1 Placebo Group 1 Intervention

Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

Group IV: Placebo_GPI2 Placebo Group 1 Intervention

Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

In a study of 579 adults with obesity, tirzepatide significantly enhanced weight loss after a 12-week lifestyle intervention, achieving an average additional weight reduction of 18.4% compared to just 2.5% with placebo over 72 weeks.

The treatment was well-tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating that tirzepatide is a safe and effective option for further weight management in individuals who have already lost weight through lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden, TA., Chao, AM., Machineni, S., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed significant reductions in Hemoglobin A1c levels (up to 3.02%) and weight loss in adults with uncontrolled type 2 diabetes, outperforming both placebo and active comparators like semaglutide.

The safety profile of tirzepatide was comparable to semaglutide regarding gastrointestinal adverse effects, and it did not increase the incidence of major cardiovascular events compared to insulin glargine, indicating it may be a valuable addition to diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]

Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).

Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. Mishra, R., Raj, R., Elshimy, G., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed greater improvements in glucose control and weight loss compared to the GLP-1 receptor agonist dulaglutide in a study involving 316 participants with type 2 diabetes.

The improvements in insulin sensitivity and beta-cell function with tirzepatide were only partially linked to weight loss, indicating that its dual receptor action provides unique mechanisms for better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. Thomas, MK., Nikooienejad, A., Bray, R., et al.[2022]

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38912654/

Tirzepatide for the Treatment of Obstructive Sleep Apnea and ... Among persons with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide reduced the AHI, body weight, hypoxic burden, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725003946

Effect of tirzepatide treatment on patient-reported outcomes ... In the SURMOUNT-OSA clinical trials, tirzepatide treatment was associated with improved quality of sleep, sleep-related functioning, and HRQoL among people with ...

3. fda.gov fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea

FDA Approves First Medication for Obstructive Sleep Apnea Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in ...

4. mediacenteratypon.nejmgroup-production.org mediacenteratypon.nejmgroup-production.org/NEJMoa2404881.pdf

Tirzepatide for the Treatment of Obstructive Sleep Apnea and ... Positive airway pressure (PAP) therapy improves the apnea–hypopnea index (AHI, the number of apneas and hypopneas during an hour of sleep) and ...

5. esmed.org esmed.org/MRA/mra/article/view/6236

Tirzepatide and Semaglutide for the Treatment ... Subgroup analysis of the AOM cohort showed that tirzepatide users had a slightly lower incidence of obstructive sleep apnea than semaglutide ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38547961/

Tirzepatide for the treatment of obstructive sleep apnea ... This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity.

7. nejm.org nejm.org/doi/10.1056/NEJMoa2404881

Tirzepatide for the Treatment of Obstructive Sleep Apnea ... Conclusions. Among persons with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide reduced the AHI, body weight, hypoxic burden ...

8. zepbound.lilly.com zepbound.lilly.com/hcp/clinical-data-sleep-apnea

Clinical Data, Safety & Study Design | OSA - Zepbound - Eli Lilly Learn more about Zepbound's® (tirzepatide) efficacy and safety clinical data for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity.