Clinical trial • Phase III • Endocrinology|Respiratory
LY3841136 SODIUM for Overweight|Obesity|Obstructive sleep apnea
Phase III trial of LY3841136 SODIUM for Overweight|Obesity|Obstructive sleep apnea.
Overview
- Trial Therapeutic Area
- Endocrinology|Respiratory
- Trial Disease
- Overweight|Obesity|Obstructive sleep apnea
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 28-11-2025
- First CTIS Authorization Date
- 20-03-2026
Trial design
Randomised, placebo to match ly (placebo to match ly); dose and schedule not specified in available record-controlled Phase III trial in Germany, Spain.
- Randomised
- Yes
- Comparator
- Placebo to match LY (Placebo to match LY); dose and schedule not specified in available record
- Target Sample Size
- 631
Eligibility
Recruits 631 adults.
Inclusion criteria
- {"criterion_text":"- Have a confirmed history of moderate-to-severe obstructive sleep apnea (OSA)"}
- {"criterion_text":"- Have a stable body weight (<5% body weight change) for 90 days prior to screening"}
- {"criterion_text":"- Have an Apnea-Hypopnea Index (AHI) ≥ 15 on polysomnography (PSG) as part of the study at screening"}
- {"criterion_text":"- For YSA1 participants: be unable or unwilling to use positive airway pressure (PAP) therapy"}
- {"criterion_text":"- 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
- {"criterion_text":"- Have had or are planning to have surgery, an endoscopic procedure, and/or devicebased therapy for weight loss (with exceptions)"}
- {"criterion_text":"- Have had or are planning to have surgery for sleep apnea or major ear, nose, or throat surgery that still may affect breathing at the time of screening"}
- {"criterion_text":"- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes"}
- {"criterion_text":"- Have had a serious heart condition within 90 days prior to screening"}
- {"criterion_text":"- Have taken medications or alternative remedies intended for weight loss within 90 days prior to screening"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent Change from Baseline in Body Weight","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 631
- Recruitment Window Months
- 20
- Consent Approach
- Informed consent to be obtained using Subject Information Sheet and Informed Consent Form (e.g. L1_SIS and ICF_Main ICF documents listed). Spanish language versions of protocol and synopsis are present; consent provided by adult participants. No assent process for minors is indicated.
Methods
- Digital recruitment via Trialbee (landing pages, digital marketing content, self-assessment and secondary assessment tools) aimed at potential participants
- Site-based recruitment using hospital/clinic sites (site-specific recruitment text)
- Printed recruitment materials: brochures, flyers, posters
- Investigator/doctor referral letters to patients
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 169
Germany
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 24
- Number Of Sites
- 9
- Number Of Participants
- 84
Sites
- Site Name
- Siteworks GmbH
- Contact Person Name
- Julia Chevts
- Contact Person Email
- chevts@siteworks-research.de
- Site Name
- Advanced Sleep Research GmbH
- Contact Person Name
- Katharina Lederer
- Contact Person Email
- katharina.lederer@advanced-sleep-research.de
- Site Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Contact Person Name
- Thomas Schaum
- Contact Person Email
- schaum@red-institut.de
- Site Name
- Siteworks GmbH
- Contact Person Name
- Ulrike Lengler
- Contact Person Email
- lengler@siteworks-research.de
- Site Name
- Universitätsklinikum Marburg
- Department Name
- Klinik für Pneumologie, Intensiv- und Schlafmedizin
- Contact Person Name
- Christian Viniol
- Contact Person Email
- christian.viniol@med.uni-marburg.de
- Site Name
- CIMS Studienzentrum Bamberg GmbH
- Contact Person Name
- Johannes Haas
- Contact Person Email
- dr.haas@besser-luft.de
- Site Name
- Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH
- Contact Person Name
- Heike Benes
- Contact Person Email
- heike.benes@somnibene.de
- Site Name
- InnoDiab Forschung GmbH
- Contact Person Name
- Thomas Schuerholz
- Contact Person Email
- thomas.schuerholz@innodiab.de
- Site Name
- Siteworks GmbH
- Contact Person Name
- Ulrike Lengler
- Contact Person Email
- lengler@siteworks-research.de
Spain
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 18
- Number Of Sites
- 9
- Number Of Participants
- 85
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Endocrinology and nutrition
- Contact Person Name
- Francisco Jose Tinahones Madueno
- Contact Person Email
- fjtinahones@hotmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Respiratory
- Contact Person Name
- Irene Cano Pumarega
- Contact Person Email
- irene.cano@yahoo.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Respiratory
- Contact Person Name
- Candelaria Caballero Eraso
- Contact Person Email
- ccaballeroeraso@gmail.com
- Site Name
- Hospital San Pedro
- Department Name
- Respiratory
- Contact Person Name
- Alejandra Roncero Lázaro
- Contact Person Email
- aroncerol@riojasalud.es
- Site Name
- Instituto De Investigaciones Del Sueno S.L.
- Contact Person Name
- Diego Garcia Borreguero
- Contact Person Email
- dgb.investigation@iis.es
- Site Name
- Hospital Universitario De Guadalajara SESCAM
- Department Name
- Sleep Unit
- Contact Person Name
- Olga Mediano San Andrés
- Contact Person Email
- olgamediano@hotmail.com
- Site Name
- Hospital Universitari De Santa Maria
- Department Name
- Respiratory / Sleep Disorders
- Contact Person Name
- Ferran Eduard Barbé Illa
- Contact Person Email
- febarbe.lleida.ics@gencat.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Respiratory
- Contact Person Name
- Francisco José García Río
- Contact Person Email
- fgrio@salud.madrid.org
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Endocrinology
- Contact Person Name
- Margarita Rivas Fernandez
- Contact Person Email
- margaritarivasfernandez@yahoo.es
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- code: 4
- Name
- IQVIA Limited
- Responsibilities
- code: 1
- Name
- Iqvia Inc.
- Responsibilities
- code: 4
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- code: 4
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code: 4
Third parties
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code: 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Eloralintide
- Active Substance
- LY3841136 SODIUM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Non-authorised investigational medicinal product (assessed as non-authorised for indication in application justification)
- Frequency
- Once weekly
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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