Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649045
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight A Randomized Double-Blind Placebo-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATTAIN-OSA
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None