A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 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.
Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.
Eligibility criteria
Qualifiers
Confirmed history of moderate-to-severe OSA
Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening
Have a BMI ≥27 kg/m2 at screening
Have a stable body weight (<5% body weight change) for 90 days prior to screening
Disqualifiers
Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening
Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
Trial design
Treatments tested in this trial
- Eloralintide
- Placebo
Treatment groups
800 Participants
are divided into 4 treatment groupsLocations
129Argentina
Centro de Investigaciones Metabólicas (CINME)C1056ABI, Buenos Aires Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaC1425AGC, Buenos Aires Argentina
Centro Médico ViamonteC1120AAC, Buenos Aires Argentina
Cicemo Srl1424, Buenos Aires Argentina
Sponsors and collaborators
Eli Lilly and Company
Lead sponsor
Source ClinicalTrials.gov