Clinical trial • Phase III • Endocrinology
LY3841136 SODIUM for Obesity | Overweight | Type 2 diabetes
Phase III trial of LY3841136 SODIUM for Obesity | Overweight | Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity | Overweight | Type 2 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 21-11-2025
- First CTIS Authorization Date
- 24-03-2026
Trial design
Randomised, placebo to match eloralintide (matching placebo). active comparator: eloralintide (ly3841136) administered once weekly (dose not specified in provided record).-controlled Phase III trial in Spain, Poland, Czechia and others.
- Randomised
- Yes
- Comparator
- Placebo to match eloralintide (matching placebo). Active comparator: Eloralintide (LY3841136) administered once weekly (dose not specified in provided record).
- Target Sample Size
- 738
- Trial Duration For Participant
- 448
Eligibility
Recruits 738 No vulnerable populations selected (isVulnerablePopulationSelected: false); trial enrols adult participants only. No specific assent/guardian consent procedures described in the available record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); trial enrols adult participants only. No specific assent/guardian consent procedures described in the available record.
Inclusion criteria
- {"criterion_text":"- Have type 2 diabetes\n- Be on stable treatment for type 2 diabetes\n- Have a BMI ≥ 27 kg/m2\n- Have a stable body weight (<5% body weight change) for 90 days prior to screeninG"}
Exclusion criteria
- {"criterion_text":"- Participants must not have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)\n- Have type 1 diabetes\n- Have taken certain medications for blood sugar within 90 days prior to screening\n- Have had a serious heart condition within 90 days prior to screening\n- 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 [Time Frame: Baseline, Week 64]","definition_or_measurement_approach":"Percent change from baseline in body weight measured at Week 64 (time frame Baseline to Week 64)."}
Recruitment
- Digital Remote Recruitment
- True, digital/remote methods include Trialbee landing pages and digital marketing campaigns, online self-assessments, and related digital privacy policy/supplementary materials (documents present in Spanish and Polish).
- Planned Sample Size
- 738
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent provided by adult participants. Subject information and informed consent forms (ICFs) and supporting materials are available in multiple languages (documents indicate Polish, Spanish, Czech, Slovak and English-language materials). Addenda and topic-specific ICFs (e.g., CGM addendum, pregnant partner) are included; no assent procedures described (adults only).
Methods
- Digital marketing and online recruitment via Trialbee (landing page, digital marketing content, Trialbee self-assessment) - targeting potential participants with obesity/overweight and Type 2 diabetes; materials available in multiple languages (e.g., Spanish, Polish).
- Site-based recruitment via healthcare providers and clinics (Doctor-to-Patient letters, doctor referral) at participating trial sites.
- Printed recruitment materials (flyers, posters, brochures, patient cards) distributed at sites and local channels.
- Third-party vendor-led patient screening and recruitment (organisations identified with recruitment responsibilities include Care Access Research LLC; Trialbee AB; IQVIA Limited).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 297
Spain
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 9
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Endocrinology
- Principal Investigator Name
- Andreea Ciudín
- Principal Investigator Email
- andreea.ciudin@vallhebron.cat
- Contact Person Name
- Andreea Ciudín
- Contact Person Email
- andreea.ciudin@vallhebron.cat
- Site Name
- Hospital Universitario De La Ribera
- Department Name
- Endocrinology
- Principal Investigator Name
- Carmen Fajardo
- Principal Investigator Email
- fajardo_carmon@gva.es
- Contact Person Name
- Carmen Fajardo
- Contact Person Email
- fajardo_carmon@gva.es
- Site Name
- Hospital Nisa Sevilla Aljarafe
- Department Name
- Endocrinology
- Principal Investigator Name
- Cristobal Morales
- Principal Investigator Email
- cr.morales@hotmail.com
- Contact Person Name
- Cristobal Morales
- Contact Person Email
- cr.morales@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Endocrinology and metabolism
- Principal Investigator Name
- Ana De Hollanda
- Principal Investigator Email
- amdehol@clinic.cat
- Contact Person Name
- Ana De Hollanda
- Contact Person Email
- amdehol@clinic.cat
- Site Name
- Hospital Ruber Juan Bravo
- Department Name
- Endocrinology and Matabolism
- Principal Investigator Name
- Esteban Jodar
- Principal Investigator Email
- esteban.jodar@gmail.com
- Contact Person Name
- Esteban Jodar
- Contact Person Email
- esteban.jodar@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Gabriel Olveira
- Principal Investigator Email
- gabrielolveiracasa@gmail.com
- Contact Person Name
- Gabriel Olveira
- Contact Person Email
- gabrielolveiracasa@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Endocrinology and nutrition
- Principal Investigator Name
- Francisco Tinahones Madueno
- Principal Investigator Email
- fjtinahones@hotmail.com
- Contact Person Name
- Francisco Tinahones Madueno
- Contact Person Email
- fjtinahones@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Endocrinology
- Principal Investigator Name
- Virginia Bellido
- Principal Investigator Email
- virginiabellido@gmail.com
- Contact Person Name
- Virginia Bellido
- Contact Person Email
- virginiabellido@gmail.com
- Site Name
- Centro Médico Compostela
- Department Name
- endocrinología
- Principal Investigator Name
- Gemma Rodriguez Carnero
- Principal Investigator Email
- mrcarnero@alumni.unav.es
- Contact Person Name
- Gemma Rodriguez Carnero
- Contact Person Email
- mrcarnero@alumni.unav.es
Poland
- Earliest CTIS Part Ii Submission Date
- 24-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 31
- Number Of Sites
- 8
- Number Of Participants
- 80
Sites
- Site Name
- Centrum Medyczne Neuromed Sp. z o.o.
- Principal Investigator Name
- Beata Lisewska
- Principal Investigator Email
- lisewskabeata@gmail.com
- Contact Person Name
- Beata Lisewska
- Contact Person Email
- lisewskabeata@gmail.com
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
- Principal Investigator Name
- Henryk Rudzki
- Principal Investigator Email
- henryk58@interia.pl
- Contact Person Name
- Henryk Rudzki
- Contact Person Email
- henryk58@interia.pl
- Site Name
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
- Principal Investigator Name
- Joanna Mirocka
- Principal Investigator Email
- jmirocka@gmail.com
- Contact Person Name
- Joanna Mirocka
- Contact Person Email
- jmirocka@gmail.com
- Site Name
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Principal Investigator Name
- Malgorzata Jozefowska
- Principal Investigator Email
- m.jozefowska@ctw.com.pl
- Contact Person Name
- Malgorzata Jozefowska
- Contact Person Email
- m.jozefowska@ctw.com.pl
- Site Name
- Ekamed Sp. z o.o.
- Principal Investigator Name
- Ewa Skokowska
- Principal Investigator Email
- skokowska@onet.pl
- Contact Person Name
- Ewa Skokowska
- Contact Person Email
- skokowska@onet.pl
- Site Name
- Ambulatorium Sp. z o.o.
- Principal Investigator Name
- Anna Bazela-Ostromecka
- Principal Investigator Email
- bazela.ann@gmail.com
- Contact Person Name
- Anna Bazela-Ostromecka
- Contact Person Email
- bazela.ann@gmail.com
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Principal Investigator Name
- Janusz Gumprecht
- Principal Investigator Email
- jgumprecht@sum.edu.pl
- Contact Person Name
- Janusz Gumprecht
- Contact Person Email
- jgumprecht@sum.edu.pl
- Site Name
- Osrodek Diabetologiczny Popula Elzbieta Poplawska Grazyna Laszewska Sp. j.
- Principal Investigator Name
- Grazyna Laszewska
- Principal Investigator Email
- glasze@gazeta.pl
- Contact Person Name
- Grazyna Laszewska
- Contact Person Email
- glasze@gazeta.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-02-2026
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 55
Sites
- Site Name
- Diabet2 s.r.o.
- Department Name
- Diabetologická a interní ambulance
- Principal Investigator Name
- Jakub Hron
- Principal Investigator Email
- hron.jakub@email.cz
- Contact Person Name
- Jakub Hron
- Contact Person Email
- hron.jakub@email.cz
- Site Name
- MUDr. Tomáš Edelsberger
- Department Name
- Diabetologie
- Principal Investigator Name
- Tomáš Edelsberger
- Principal Investigator Email
- edelsberger@gmail.com
- Contact Person Name
- Tomáš Edelsberger
- Contact Person Email
- edelsberger@gmail.com
- Site Name
- MUDr. Jana Parkányiová
- Department Name
- Endokrinologie a diabetologie
- Principal Investigator Name
- Jana Parkányiová
- Principal Investigator Email
- jana.parkanyiova@gmail.com
- Contact Person Name
- Jana Parkányiová
- Contact Person Email
- jana.parkanyiova@gmail.com
- Site Name
- MUDr. Miroslav Koliba s.r.o.
- Principal Investigator Name
- Miroslav Koliba
- Principal Investigator Email
- miroslav.koliba2@gmail.com
- Contact Person Name
- Miroslav Koliba
- Contact Person Email
- miroslav.koliba2@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 13
- Number Of Sites
- 7
- Number Of Participants
- 40
Sites
- Site Name
- InnoDiab Forschung GmbH
- Principal Investigator Name
- Helga Zeller
- Principal Investigator Email
- helga.zeller@innodiab.de
- Contact Person Name
- Helga Zeller
- Contact Person Email
- helga.zeller@innodiab.de
- Site Name
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
- Principal Investigator Name
- Winfried Keuthage
- Principal Investigator Email
- studien@diabetes-praxis-muenster.de
- Contact Person Name
- Winfried Keuthage
- Contact Person Email
- studien@diabetes-praxis-muenster.de
- Site Name
- Diabetes-Zentrum-Wilhelmsburg GbR
- Principal Investigator Name
- Peter Witzel
- Principal Investigator Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Contact Person Name
- Peter Witzel
- Contact Person Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Site Name
- Diabetologische Schwerpunktpraxis
- Principal Investigator Name
- Kai Koenemann
- Principal Investigator Email
- dr.koenemann@diabetes-buende.de
- Contact Person Name
- Kai Koenemann
- Contact Person Email
- dr.koenemann@diabetes-buende.de
- Site Name
- Institut fuer Diabetesforschung Muenster GmbH
- Principal Investigator Name
- Ludger Rose
- Principal Investigator Email
- l.rose@diabetes-muenster.de
- Contact Person Name
- Ludger Rose
- Contact Person Email
- l.rose@diabetes-muenster.de
- Site Name
- Diabetespraxis Dr. Braun
- Principal Investigator Name
- Hermann Braun
- Principal Investigator Email
- braun@diabetespraxis-braun.de
- Contact Person Name
- Hermann Braun
- Contact Person Email
- braun@diabetespraxis-braun.de
- Site Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Principal Investigator Name
- Thomas Schaum
- Principal Investigator Email
- schaum@red-institut.de
- Contact Person Name
- Thomas Schaum
- Contact Person Email
- schaum@red-institut.de
Slovakia
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 67
Sites
- Site Name
- B-Medical s.r.o.
- Principal Investigator Name
- Maria Balekova
- Principal Investigator Email
- mariakanderkova@gmail.com
- Contact Person Name
- Maria Balekova
- Contact Person Email
- mariakanderkova@gmail.com
- Site Name
- Diacrin s.r.o.
- Principal Investigator Name
- Eva Zakovicova
- Principal Investigator Email
- evazakovicova@seznam.cz
- Contact Person Name
- Eva Zakovicova
- Contact Person Email
- evazakovicova@seznam.cz
- Site Name
- Funkystuff s.r.o.
- Principal Investigator Name
- Miriam Teplanova
- Principal Investigator Email
- 66funkyman@gmail.com
- Contact Person Name
- Miriam Teplanova
- Contact Person Email
- 66funkyman@gmail.com
- Site Name
- MediVet s.r.o.
- Department Name
- DIAMA Diabetes Center
- Principal Investigator Name
- Eva Pavleova
- Principal Investigator Email
- pavle.eva@gmail.com
- Contact Person Name
- Eva Pavleova
- Contact Person Email
- pavle.eva@gmail.com
- Site Name
- Medi-Dia s.r.o.
- Principal Investigator Name
- Martina Merciakova
- Principal Investigator Email
- mmerciakova@gmail.com
- Contact Person Name
- Martina Merciakova
- Contact Person Email
- mmerciakova@gmail.com
- Site Name
- DIA-MED CENTRUM s.r.o.
- Principal Investigator Name
- Ludmila Kubincova
- Principal Investigator Email
- kubincova.ludmila@gmail.com
- Contact Person Name
- Ludmila Kubincova
- Contact Person Email
- kubincova.ludmila@gmail.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research LLC
- Responsibilities
- Laboratory and Diagnostics
- Name
- Iqvia Inc.
- Responsibilities
- Laboratory and Diagnostics
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties code: 1
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- Laboratory and Diagnostics
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Laboratory and Diagnostics
- Name
- Care Access Research LLC
- Responsibilities
- Patient Screening, Recruitment, and/or Retention
- Name
- Trialbee AB
- Responsibilities
- Patient Screening, Recruitment, and/or Retention
Third parties
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Care Access Research LLC","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Health care"}
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Laboratory and Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Laboratory and Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Laboratory and Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory and Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Eloralintide (LY3841136)
- Active Substance
- LY3841136 SODIUM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Not authorised (investigational)
- Frequency
- Once weekly
- Investigational Product Name
- Placebo to match ly
- Modality
- Other
- Authorisation Status
- Not applicable (placebo used as comparator)
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