Tirzepatide for Obstructive Sleep Apnea and Obesity

(SURMOUNT-OSA Trial)

Recruiting at 77 trial locations

Overseen By Stacey Layle

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

469 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the drug Tirzepatide for treating obesity and obstructive sleep apnea?

Tirzepatide has shown significant effectiveness in reducing body weight and improving glucose control in people with type 2 diabetes, which suggests it may also help with obesity-related conditions like obstructive sleep apnea. In clinical trials, it led to greater weight loss compared to other treatments, which is important for managing obesity. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been tested in several clinical trials for type 2 diabetes and obesity, showing common side effects like nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has been found to be generally safe for the heart, with no increased risk of major cardiovascular events. ^{1 2 4 5 6}

How is the drug tirzepatide unique for treating obstructive sleep apnea and obesity?

Tirzepatide is unique because it is a dual-action drug that targets both GIP and GLP-1 receptors, which are involved in insulin secretion and appetite regulation, leading to significant weight loss. This dual mechanism is different from other treatments that typically target only one of these pathways. ^{2 5 7 8 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. [2022]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Change in pharmacodynamic variables following once-weekly tirzepatide treatment versus dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono substudy). [2023]

4. England pubmed.ncbi.nlm.nih.gov

Separate and combined effects of long-term GIP and GLP-1 receptor activation in patients with type 2 diabetes: a structured summary of a study protocol for a double-blind, randomised, placebo-controlled clinical trial. [2023]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. [2023]