A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA)
Key facts
- Where
- Bamberg, Berlin, Essen, Hanover, Karlsruhe, Muenster és Oldenburg in Holstein, NémetországSee the 8 sites
- Phase
- 3. fázis
Where in Németország
- CIMS Studienzentrum Bamberg GmbHBamberg, NémetországNo longer taking part
- Advanced Sleep Research GmbHBerlin, NémetországNo longer taking part
- InnoDiab Forschung GmbhEssen, NémetországNo longer taking part
- Uhz Klinische ForschungEssen, NémetországNo longer taking part
- Siteworks GmbHHanover, NémetországNo longer taking part
- Siteworks GmbHKarlsruhe, NémetországNo longer taking part
- Institut fuer Diabetesforschung Muenster GmbHMuenster, NémetországNo longer taking part
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly & Co.
- Trial code
- EU 2024-515905-25-00
- Record updated
- 2026. október 19.
- Original description
To demonstrate that orforglipron is superior to placebo for change in Apnea-Hypopnea Index (AHI).Read full original descriptionShow less
J5P-MC-GZRA: 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 (ATTAIN-OSA); J5P-MC-GZ01: Participants with OSA unable or unwilling to use PAP therapy; J5P-MC-GZ02: Participants with OSA on PAP therapy
To demonstrate that orforglipron is superior to placebo for change in Apnea-Hypopnea Index (AHI).
Inclusion: (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.
Exclusion: (GZRA) Have a prior or planned endoscopic and/or present device-based therapy for 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) Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery; (GZRA) Active device treatment of OSA other than PAP therapy; (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); (GZRA) Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma; (GZRA) Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity; (GZRA) Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia; (GZRA) Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator; (GZRA) Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1; (GZRA) Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration.