600 Participants Needed

Orforglipron for Obstructive Sleep Apnea

(ATTAIN-OSA Trial)

Recruiting at 77 trial locations
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Overseen ByThere 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
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12346

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.12347

Research Team

C1

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.
See 5 more

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
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OrforglipronExperimental Treatment1 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: PlaceboPlacebo Group1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

References

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]
Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]
Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]
In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. [2023]
The Case for Early Use of Glucagon-like Peptide-1 Receptor Agonists in Obstructive Sleep Apnea Patients with Comorbid Diabetes and Metabolic Syndrome. [2022]
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]
Efficacy and safety of liraglutide in patients with type 2 diabetes mellitus and severe obstructive sleep apnea. [2023]
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