Orforglipron for Obstructive Sleep Apnea

(ATTAIN-OSA Trial)

Recruiting at77 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Upper airway surgery, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

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.

What data supports the effectiveness of the drug Orforglipron for treating obstructive sleep apnea?

Orforglipron, a drug similar to other glucagon-like peptide-1 receptor agonists, has shown effectiveness in managing conditions like type 2 diabetes and obesity, which are often linked to obstructive sleep apnea. These drugs can help improve related health issues, potentially benefiting those with sleep apnea. ^{1 2 3 4 5}

Is Orforglipron safe for humans?

Orforglipron has been tested in several studies for conditions like type 2 diabetes and obesity, and these studies have evaluated its safety. The trials generally found it to be safe, with no major safety concerns reported in healthy participants or those with these conditions. ^{1 2 3 4 6}

How is the drug orforglipron different from other treatments for obstructive sleep apnea?

Orforglipron is unique because it is an oral, non-peptide drug that targets the glucagon-like peptide-1 (GLP-1) receptor, which is different from many existing treatments for obstructive sleep apnea that do not focus on this mechanism. It is also being studied for its effects on type 2 diabetes and obesity, which are conditions often associated with sleep apnea. ^{1 2 3 4 7}

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 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.

Trial Timeline

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

Treatment Details

Interventions

• Orforglipron (Other)

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.

Participant Groups

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

Findings from Research

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]

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 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]

References

1. England 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. [2023]

2. England 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. [2023]

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

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]

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

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

5. Switzerland 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. [2022]

6. England 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. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of liraglutide in patients with type 2 diabetes mellitus and severe obstructive sleep apnea. [2023]