Orforglipron for Obstructive Sleep Apnea

(ATTAIN-OSA Trial)

Not currently recruiting at 89 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Upper airway 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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new oral treatment called orforglipron for individuals with moderate-to-severe obstructive sleep apnea (OSA) who are overweight or obese. Participants are divided into two groups: one for those who cannot or do not wish to use CPAP machines, and another for those who have used CPAP for at least three months. Suitable candidates for this trial include individuals with OSA who have a BMI of 27 or higher and either do not use CPAP or have been using it regularly and plan to continue. The trial aims to determine if orforglipron can manage OSA symptoms alongside or instead of CPAP therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for OSA.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on PAP therapy, you may need to temporarily stop it for 7 days before certain tests during the study.

Is there any evidence suggesting that orforglipron is likely to be safe for humans?

Research has shown that orforglipron is usually well-tolerated. In studies, most participants experienced only mild to moderate side effects, such as nausea and diarrhea. These side effects were generally temporary and not serious.

Orforglipron is currently being tested for safety in aiding weight loss and managing type 2 diabetes, indicating some existing evidence about its safety. However, individual reactions can vary, so monitoring for any side effects during the trial is important.

For concerns about side effects, discussing them with the trial team is advisable. They can provide more detailed information and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for obstructive sleep apnea, which typically involves continuous positive airway pressure (CPAP) machines, orforglipron offers a unique oral treatment option. Researchers are excited about orforglipron because it targets the condition directly through a new active ingredient, potentially providing an alternative for those unable or unwilling to use traditional CPAP therapy. This could mean more accessible and comfortable management of sleep apnea symptoms.

What evidence suggests that orforglipron might be an effective treatment for obstructive sleep apnea?

Research has shown that orforglipron, a new pill, is being tested in this trial to determine its effectiveness for obstructive sleep apnea (OSA) in individuals who are overweight or have obesity. Participants will receive either orforglipron or a placebo. While specific information on OSA is still being collected, orforglipron has already demonstrated promise in other areas by lowering blood sugar levels by 1.3% to 1.6%. This drug is a type of GLP-1 receptor agonist, which helps control appetite and weight, potentially reducing OSA symptoms. Its long-lasting effects allow for convenient once-a-day dosing. Early studies are examining its effectiveness for OSA, but its known weight-loss benefits suggest it could be helpful. ^{1 6 7 8 9}

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 people with moderate-to-severe obstructive sleep apnea (OSA) and obesity or overweight. Participants must have an Apnea-Hypopnea Index (AHI) of at least 15 and a BMI of 27 kg/m² or higher. One part of the study includes those not using Positive Airway Pressure (PAP) therapy, while another involves participants who've been on PAP for at least three months.

Inclusion Criteria

My BMI is 27 or higher.

I meet the specific requirements for Study 1 GZ01.

I haven't used PAP therapy in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to evaluate efficacy and safety in those with moderate-to-severe OSA and obesity or overweight

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron

Trial Overview The trial is testing Orforglipron's effectiveness and safety in treating OSA among obese or overweight individuals. It compares Orforglipron to a placebo, with one group receiving the actual drug and another getting a non-active substance, to see if there's any improvement in their condition.

How Is the Trial Designed?

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy

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

In a phase 2 trial involving 272 adults with obesity, the oral GLP-1 receptor agonist orforglipron resulted in significant weight loss, with participants losing between 8.6% to 14.7% of their body weight by week 36, compared to only 2.3% in the placebo group.

Orforglipron was generally well-tolerated, with mild to moderate gastrointestinal side effects being the most common adverse events, leading to discontinuation in 10-17% of participants, similar to the safety profile of injectable GLP-1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. Wharton, S., Blevins, T., Connery, L., et al.[2023]

A study involving adults with obesity demonstrated that the daily oral GLP-1 receptor agonist orforglipron effectively aids in weight loss, showcasing its potential as a treatment option for obesity.

The findings suggest that orforglipron may offer a convenient oral alternative to traditional injectable GLP-1 receptor agonists, enhancing patient adherence to obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. Lau, D.[2023]

In a Phase 1 study involving 92 healthy adults, orforglipron (LY3502970) demonstrated a favorable safety profile, with gastrointestinal issues being the most common side effects, and showed a long half-life of 25-68 hours, allowing for convenient once-daily oral dosing.

Participants taking orforglipron experienced significant weight loss (up to 5.4 kg) and reductions in fasting glucose levels over 4 weeks, indicating its potential efficacy as a glucagon-like peptide-1 receptor agonist for managing weight and blood sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1a, blinded, placebo-controlled, randomized, single- and multiple-ascending-dose study in healthy participants. Pratt, E., Ma, X., Liu, R., et al.[2023]

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) can effectively address multiple comorbidities associated with obstructive sleep apnea (OSA), such as type 2 diabetes, hypertension, and obesity, potentially reducing the need for multiple medications.

The use of GLP-1RAs in OSA patients may lower healthcare costs, decrease the risk of adverse drug interactions, and improve overall quality of life, making them a valuable treatment option for managing these interconnected health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Early Use of Glucagon-like Peptide-1 Receptor Agonists in Obstructive Sleep Apnea Patients with Comorbid Diabetes and Metabolic Syndrome. Sultana, R., Sissoho, F., Kaushik, VP., et al.[2022]

In a Phase 1b trial involving 68 participants with type 2 diabetes, orforglipron (LY3502970) demonstrated significant reductions in HbA1c levels (by -1.5% to -1.8%) and body weight (by -0.24 to -5.8 kg) compared to placebo, which only showed a -0.4% change in HbA1c.

Orforglipron was generally well tolerated, with gastrointestinal side effects similar to those seen with other GLP-1 receptor agonists, suggesting it may be a safe and effective oral alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. Pratt, E., Ma, X., Liu, R., et al.[2023]

In a study of 90 patients with type 2 diabetes and severe obstructive sleep apnea, liraglutide combined with CPAP significantly reduced body mass index (BMI), mean systolic blood pressure, and improved apnea hypopnea index (AHI) scores after 3 months.

Liraglutide did not increase the incidence of side effects compared to the control group, indicating it is a safe addition to the treatment regimen for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of liraglutide in patients with type 2 diabetes mellitus and severe obstructive sleep apnea. Jiang, W., Li, W., Cheng, J., et al.[2023]

In a 26-week phase 2 trial involving 383 participants with type 2 diabetes, orforglipron significantly reduced HbA1c levels by up to -2.10% compared to placebo and showed greater weight loss of up to -10.1 kg, indicating its efficacy as a treatment option.

The safety profile of orforglipron was comparable to other GLP-1 receptor agonists, with most adverse events being mild to moderate gastrointestinal issues, suggesting it may be a safer and more convenient alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Frias, JP., Hsia, S., Eyde, S., et al.[2023]

Citations

1. investor.lilly.com investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically

Lilly's oral GLP-1, orforglipron, demonstrated statistically ... Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37344954/

Orforglipron (LY3502970), a novel, oral non-peptide ... Orforglipron's long half-life (25-68 hours) allows once-daily oral dosing, without water and food restrictions.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05869903

NCT05869903 | A Study of Orforglipron (LY3502970) in ... This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related ...

4. rxagentai.com rxagentai.com/sample-reports/Drug%20Agent_orforglipron%20Sample.pdf

ORFORGLIPRON Obstructive Sleep Apnea: Orforglipron is under investigation for the treatment of obstructive sleep apnea in individuals with obesity or ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-of-orforglipron-for-patients-with-obstructive-sleep-apnea-and-obesity-or-overweight/

Study on the Effectiveness of Orforglipron for Patients ... This study investigates the effectiveness of Orforglipron in treating individuals with Obstructive Sleep Apnea and weight-related issues, by comparing its ...

6. mdpi.com mdpi.com/2673-5318/6/3/111

Efficacy and Safety of Glucagon-like Peptide-1 Receptor ... Efficacy and Safety of Glucagon-like Peptide-1 Receptor Agonists for Treatment of Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis of Randomized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11938315/

Safety and efficacy of glucagon-like peptide-1 receptor ... Safety and efficacy of glucagon-like peptide-1 receptor agonists in patients with obstructive sleep apnea: a systematic review and meta-analysis ...

8. lilly.com lilly.com/news/stories/what-to-know-about-orforglipron

What to Know About Orforglipron Oral GLP-1 Is orforglipron safe to take? Orforglipron is currently being evaluated for safety in the treatment of weight loss and type 2 diabetes through clinical trials ...

9. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06302-y

GLP-1 agonists for sleep apnea in obese T2D patients Patients with obesity and OSA may consider GLP-1 RA as a potential treatment option if the adverse events are deemed tolerable. Introduction.