Orforglipron for Obstructive Sleep Apnea (ATTAIN-OSA Trial)

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Participants who are unable or unwilling to use PAP therapy.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will consist of two separate studies, GZ01 and GZ02, that will evaluate the effectiveness and safety of orforglipron in participants with moderate-to-severe obstructive sleep ap

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with new treatments like Orforglipron could include digestive issues, headaches, dizziness, potential allergic reactions, or other unforeseen responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I cannot or will not use PAP therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orforglipron

2024

Completed Phase 1

~80

0 / 1Eligibility criteria met