BridgeMD
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA)
EU CTIS ID: 2024-515905-25-00
What this study is testing
To demonstrate that orforglipron is superior to placebo for change in Apnea-Hypopnea Index (AHI).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (GZRA) Have AHI ≥15 on PSG as part of the trial at screening (V1).
- (GZRA) Have body mass index (BMI) ≥27 kg/m².
- (GZ01) Participants who are unable or unwilling to use PAP therapy.
- (GZ01) Participants must not have used PAP for at least 4 weeks prior to screening.
- (GZ02) Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
You likely can't join if
- (GZRA) Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma.
- (GZRA) Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- (GZRA) Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- (GZ02) 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 study.
- (GZ02) Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
- (GZRA) Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
See the full eligibility criteria
- (GZRA) Have AHI ≥15 on PSG as part of the trial at screening (V1).
- (GZRA) Have body mass index (BMI) ≥27 kg/m².
- (GZ01) Participants who are unable or unwilling to use PAP therapy.
- (GZ01) Participants must not have used PAP for at least 4 weeks prior to screening.
- (GZ02) Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
- (GZRA) Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma.
- (GZRA) Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- (GZRA) Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- (GZ02) 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 study.
- (GZ02) Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
- (GZRA) Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
- (GZRA) Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery.
- (GZRA) Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration.
- (GZRA) Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- (GZRA) Active device treatment of OSA other than PAP therapy.
- (GZRA) Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- (GZRA) Have a self-reported change in body weight >5 kg within 3 months prior to screening.
- (GZRA) Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Brazil
- Taiwan
- China
- Mexico
- India
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Brazil; Taiwan; China; Mexico and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.