Clinical trial

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Recruiting now · Phase 3 · 4 countries · Registry ID NCT07369011

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionSleep Apnea, Obstructive, Obesity, Overweight

Full registry criteria

Inclusion Criteria: * 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 * Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight For YSA1 Participants: * Are unable or unwilling to use PAP therapy For YSA2 Participants: * Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study Exclusion Criteria: * 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 * Have had within 90 days prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure * Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Treatments and study arms

Eloralintide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Percent Change from Baseline in Body WeightBaseline, Week 64
Change from Baseline in Apnea-Hypopnea Index (AHI)Baseline, Week 64

Study locations

115 locations were listed when this page was built. The first 40 are shown.

Nightingale Research🇦🇺 Adelaide, Australia
Andrew HamiltonPrincipal Investigator
Flinders University🇦🇺 Bedford Park, Australia
Study contactContact
Danny EckertPrincipal Investigator
Box Hill Hospital🇦🇺 Box Hill, Australia
Ming Li YeePrincipal Investigator
Core Research Group🇦🇺 Brisbane, Australia
Study contactContact
David ColquhounPrincipal Investigator
Austin Health - Repatriation Hospital🇦🇺 Heidelberg West, Australia
Study contactContact
Elif EkinciPrincipal Investigator
CDH Research Institute Pty Ltd🇦🇺 Maroochydore, Australia
Study contactContact
Hansjoerg SeltenreichPrincipal Investigator
Gold Coast University Hospital🇦🇺 Southport, Australia
Study contactContact
George TayPrincipal Investigator
TrialsWest - Spearwood🇦🇺 Spearwood, Australia
Study contactContact
Peter BremnerPrincipal Investigator
Instituto de Pesquisa clinica de Campinas🇧🇷 Campinas, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM🇧🇷 Marília, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul🇧🇷 Porto Alegre, Brazil
CEMER - Centro Médico do Recife🇧🇷 Recife, Brazil
Ruschel Medicina e Pesquisa Clínica🇧🇷 Rio de Janeiro, Brazil
Prognosis Pesquisa Clínica🇧🇷 Santo André, Brazil
BR Trials - Ensaios Clinicos e Consultoria🇧🇷 São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)🇧🇷 São Paulo, Brazil
Incor - Instituto do Coracao🇧🇷 São Paulo, Brazil
MyCliniResearch, Inc.🇨🇦 Calgary, Canada
Study contactContact
Wilfred AlonsoPrincipal Investigator
Alpha Recherche Clinique - Lévis🇨🇦 Lévis, Canada
Study contactContact
Dominique DeschênesPrincipal Investigator
Alpha Recherche Clinique🇨🇦 Québec, Canada
Nancy LabrecquePrincipal Investigator
C.I.C. Saint-Laurent🇨🇦 Saint-Laurent, Canada
Study contactContact
Emilie MillairePrincipal Investigator
Maple Leaf Research🇨🇦 Toronto, Canada
Study contactContact
Graham SmithPrincipal Investigator
C.I.C. Mauricie inc.🇨🇦 Trois-Rivières, Canada
Pierre-Alexandre MenardPrincipal Investigator
China-Japan Friendship Hospital🇨🇳 Beijing, China
Xiaolei ZhangPrincipal Investigator
The First Hospital of Jilin University🇨🇳 Changchun, China
Study contactContact
Guixia WangPrincipal Investigator
The Second Hospital of Jilin University🇨🇳 Changchun, China
Hanqing CaiPrincipal Investigator
The Third Xiangya Hospital of Central South University🇨🇳 Changsha, China
Ping JinPrincipal Investigator
Sichuan Provincial People's Hospital🇨🇳 Chengdu, China
Yan YangPrincipal Investigator
The First Affiliated Hospital of Chongqing Medical University🇨🇳 Chongqing, China
Tao ChenPrincipal Investigator
The First Affiliated Hospital of Guangzhou Medical University🇨🇳 Guangzhou, China
Nuofu ZhangPrincipal Investigator
The Second People's Hospital of Hefei🇨🇳 Hefei, China
Study contactContact
Jun YePrincipal Investigator
The First People's Hospital of Yunnan Province🇨🇳 Kunming, China
Study contactContact
Yikun ZhouPrincipal Investigator
Gansu Provincial Hospital🇨🇳 Lanzhou, China
Peilin HuiPrincipal Investigator
The First Affiliated Hospital of Henan University of Science &Technology🇨🇳 Luoyang Shi, China
Study contactContact
Hongwei JiangPrincipal Investigator
Jiangxi Provincial People's Hospital🇨🇳 Nanchang, China
Study contactContact
Zongyou ChengPrincipal Investigator
Nanjing First Hospital🇨🇳 Nanjing, China
Qian LiPrincipal Investigator
The Second Affiliated Hospital of Guangxi Medical University🇨🇳 Nanning, China
xiaoyu TanPrincipal Investigator
Ningbo First Hospital🇨🇳 Ningbo, China
Study contactContact
Li LiPrincipal Investigator
Shanghai East Hospital🇨🇳 Shanghai, China
You YinPrincipal Investigator