Clinical trial • Phase III • Endocrinology|Musculoskeletal
LY3841136 SODIUM for Osteoarthritis of the knee|Obesity|Overweight
Phase III trial of LY3841136 SODIUM for Osteoarthritis of the knee|Obesity|Overweight.
Overview
- Trial Therapeutic Area
- Endocrinology|Musculoskeletal
- Trial Disease
- Osteoarthritis of the knee|Obesity|Overweight
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-12-2025
- First CTIS Authorization Date
- 02-04-2026
Trial design
Randomised, placebo to match eloralintide (placebo to match ly); administered to match the eloralintide schedule (eloralintide given once weekly); specific dose not stated in the record.-controlled Phase III trial in Belgium, Denmark, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo to match Eloralintide (Placebo to match LY); administered to match the Eloralintide schedule (Eloralintide given once weekly); specific dose not stated in the record.
- Target Sample Size
- 789
- Trial Duration For Participant
- 448
Eligibility
Recruits 789 Vulnerable population selected. Informed consent is obtained via written ICF and eConsent (participant-facing eConsent materials and screenshots are included in the documentation). Participant-facing materials and ICFs are provided in English, BE-FR (Belgian French) and BE-DU (Belgian Dutch). No specific assent or parental consent procedures for minors are described in the provided record..
- Vulnerable Population
- Vulnerable population selected. Informed consent is obtained via written ICF and eConsent (participant-facing eConsent materials and screenshots are included in the documentation). Participant-facing materials and ICFs are provided in English, BE-FR (Belgian French) and BE-DU (Belgian Dutch). No specific assent or parental consent procedures for minors are described in the provided record.
Inclusion criteria
- {"criterion_text":"- Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening\n- Have a stable body weight (less than 5% body weight change) for 90 days prior to screening\n- Have tried at least once to lose weight through diet but were unsuccessful\n- Have osteoarthritis of the knee and at least one of the following conditions; Be over 50 years old, Have morning knee stiffness that lasts about 30 minutes, Have a crackling or grinding sound or feeling in the knee"}
Exclusion criteria
- {"criterion_text":"- Have an active knee infection\n- 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, type 2 diabetes, or any other type of 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]\n- Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Time Frame: Baseline, Week 64]","definition_or_measurement_approach":"Percent change from baseline in body weight measured at Week 64 compared to baseline; Change from baseline in WOMAC Pain Subscale Score measured at Week 64 compared to baseline (time frame Baseline to Week 64)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 789
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent obtained using a written Informed Consent Form (ICF) and eConsent (participant-facing eConsent screenshots and materials are provided). Sponsor ICFs and participant materials are available in English, Belgian French (BE-FR) and Belgian Dutch (BE-DU). A Pregnant Partner ICF is included in the document list. The record does not describe assent or parental consent procedures for minors.
Methods
- Site-based recruitment including doctor-to-patient letters and referrals (Dr-to-Patient Letter, Dr-Referral Letter) at participating clinics and hospitals (documents associated with Belgium, Czechia, Denmark, Germany).
- Printed materials at sites: posters, flyers, brochures (K2_Recruitment material_Poster/Flyer/Brochure files listed).
- Digital recruitment and landing pages: Trialbee and sponsor/CRO landing pages and digital marketing content (documents: Trialbee Landing Page, Trialbee Digital Marketing Content, Patient-facing landing page, IQVIA Complete Consent Participant-Facing Screenshots).
- eConsent-driven recruitment and remote consent: eConsent participant-facing screenshots and eConsent submission letters (documents indicate eConsent workflows and ZoomHealth screenshots).
- Use of third-party recruitment and patient-referral services (IQVIA, Trialbee, Care Access Research LLC, Sanos A/S and others) supporting patient referral, recruitment, screening and retention.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 789
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-04-2026
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 4
- Number Of Sites
- 8
- Number Of Participants
- 10
Sites
- Site Name
- Hip & Knee Unit in Sint-Martens-Latem
- Principal Investigator Name
- Peter Vansintjan
- Principal Investigator Email
- pieter.vansintjan@mijnziekenhuis.be
- Contact Person Name
- Peter Vansintjan
- Contact Person Email
- pieter.vansintjan@mijnziekenhuis.be
- Site Name
- ZNA Jan Palfijn
- Department Name
- Rheumatology
- Principal Investigator Name
- Alla Ishchenko
- Principal Investigator Email
- alla.ishchenko@zas.be
- Contact Person Name
- Alla Ishchenko
- Contact Person Email
- alla.ishchenko@zas.be
- Site Name
- Reumaclinic
- Department Name
- Reuma
- Principal Investigator Name
- Johan Vanhoof
- Principal Investigator Email
- johanvanhoof@skynet.be
- Contact Person Name
- Johan Vanhoof
- Contact Person Email
- johanvanhoof@skynet.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Rheumatology
- Principal Investigator Name
- Ruth Wittoek
- Principal Investigator Email
- ruth.wittoek@ugent.be
- Contact Person Name
- Ruth Wittoek
- Contact Person Email
- ruth.wittoek@ugent.be
- Site Name
- UZ Leuven
- Department Name
- Rheumatology
- Principal Investigator Name
- Kurt de Vlam
- Principal Investigator Email
- kurt.devlam@uzleuven.be
- Contact Person Name
- Kurt de Vlam
- Contact Person Email
- kurt.devlam@uzleuven.be
- Site Name
- Kormont
- Department Name
- Kormont
- Principal Investigator Name
- Klaas Vercruysse
- Principal Investigator Email
- klaas.vercruysse@telenet.be
- Contact Person Name
- Klaas Vercruysse
- Contact Person Email
- klaas.vercruysse@telenet.be
- Site Name
- Meclinas
- Department Name
- Meclinas
- Principal Investigator Name
- Julie Casaer
- Principal Investigator Email
- julie.casaer@meclinas.com
- Contact Person Name
- Julie Casaer
- Contact Person Email
- julie.casaer@meclinas.com
- Site Name
- Hip & Knee Unit in Sint-Martens-Latem (duplicate entry in list)
- Principal Investigator Name
- Peter Vansintjan
- Principal Investigator Email
- pieter.vansintjan@mijnziekenhuis.be
- Contact Person Name
- Peter Vansintjan
- Contact Person Email
- pieter.vansintjan@mijnziekenhuis.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 24-03-2026
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Sanos A/S (Vejle)
- Department Name
- Sanos
- Principal Investigator Name
- Sidsel Boll
- Principal Investigator Email
- sib@sanosclinic.com
- Contact Person Name
- Sidsel Boll
- Contact Person Email
- sib@sanosclinic.com
- Site Name
- Sanos A/S (Gandrup)
- Department Name
- Sanos
- Principal Investigator Name
- Janani Umachanger
- Principal Investigator Email
- jak@sanosclinic.com
- Contact Person Name
- Janani Umachanger
- Contact Person Email
- jak@sanosclinic.com
- Site Name
- Sanos A/S (Herlev)
- Department Name
- Sanos
- Principal Investigator Name
- Linda Bracher
- Principal Investigator Email
- lbr@sanosclinic.com
- Contact Person Name
- Linda Bracher
- Contact Person Email
- lbr@sanosclinic.com
Germany
- Earliest CTIS Part Ii Submission Date
- 13-03-2026
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 20
- Number Of Sites
- 8
- Number Of Participants
- 10
Sites
- Site Name
- Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann
- 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
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
- Department Name
- HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg
- Principal Investigator Name
- Andrea Everding
- Principal Investigator Email
- everding@hotmail.de
- Contact Person Name
- Andrea Everding
- Contact Person Email
- everding@hotmail.de
- Site Name
- CDG Studienambulanz Hartard
- Principal Investigator Name
- Manfred Hartard
- Principal Investigator Email
- m.hartard@cdg-muenchen.de
- Contact Person Name
- Manfred Hartard
- Contact Person Email
- m.hartard@cdg-muenchen.de
- Site Name
- MVZ Hausaerzte Grossenbaum GmbH
- Principal Investigator Name
- Matthias Kuenster
- Principal Investigator Email
- kuenster@hausaerzte-grossenbaum.de
- Contact Person Name
- Matthias Kuenster
- Contact Person Email
- kuenster@hausaerzte-grossenbaum.de
- Site Name
- Ambenet GmbH Das Ambulante Behandlungsnetz
- Department Name
- AmBeNet GmbH
- Principal Investigator Name
- Hans-Detlev Stahl
- Principal Investigator Email
- ds@ambenet.de
- Contact Person Name
- Hans-Detlev Stahl
- Contact Person Email
- ds@ambenet.de
- Site Name
- FutureMeds GmbH
- Principal Investigator Name
- Christel Contzen
- Principal Investigator Email
- christel.contzen@globalaes.com
- Contact Person Name
- Christel Contzen
- Contact Person Email
- christel.contzen@globalaes.com
- Site Name
- Siteworks GmbH (Bochum)
- Principal Investigator Name
- Annemone Koechel
- Principal Investigator Email
- koechel@siteworks-research.de
- Contact Person Name
- Annemone Koechel
- Contact Person Email
- koechel@siteworks-research.de
- Site Name
- Siteworks GmbH (Karlsruhe)
- Principal Investigator Name
- Julia Chevts
- Principal Investigator Email
- chevts@siteworks-research.de
- Contact Person Name
- Julia Chevts
- Contact Person Email
- chevts@siteworks-research.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 72
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Inrea s.r.o.
- Department Name
- Interni a revmatologicka ambulance
- Principal Investigator Name
- Martina Malcova
- Principal Investigator Email
- mmalcova@seznam.cz
- Contact Person Name
- Martina Malcova
- Contact Person Email
- mmalcova@seznam.cz
- Site Name
- Pratia Brno s.r.o.
- Principal Investigator Name
- Simona Pappova
- Principal Investigator Email
- simona.pappova@pratia.com
- Contact Person Name
- Simona Pappova
- Contact Person Email
- simona.pappova@pratia.com
- Site Name
- Pratia Pardubice a.s.
- Principal Investigator Name
- Marcela Svobodova
- Principal Investigator Email
- maca.svobodova@post.cz
- Contact Person Name
- Marcela Svobodova
- Contact Person Email
- maca.svobodova@post.cz
- Site Name
- MEDICAL PLUS Research s.r.o.
- Principal Investigator Name
- Eva Dokoupilova
- Principal Investigator Email
- evadokoupil@gmail.com
- Contact Person Name
- Eva Dokoupilova
- Contact Person Email
- evadokoupil@gmail.com
- Site Name
- Revmatologie s.r.o.
- Principal Investigator Name
- Leona Prochazkova
- Principal Investigator Email
- revmatologie.prochazkova@seznam.cz
- Contact Person Name
- Leona Prochazkova
- Contact Person Email
- revmatologie.prochazkova@seznam.cz
- Site Name
- Pratia Pardubice / additional listing
- Principal Investigator Name
- Marcela Svobodova
- Principal Investigator Email
- maca.svobodova@post.cz
- Contact Person Name
- Marcela Svobodova
- Contact Person Email
- maca.svobodova@post.cz
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties code: 1 (listed as third party; contact els.vannylen@iqvia.com)
- Name
- RWS Life Sciences Inc.
- Responsibilities
- Data Management - Copyright licensing; Data Management-Linguistically Validated Translations
- Name
- Trialbee AB
- Responsibilities
- Study Development / Conduct : Patient Referral, Recruitment, Screening, and/or Retention
- Name
- LabCorp Drug Development Inc
- Responsibilities
- Laboratory and Diagnostics - Central Lab
- Name
- Iqvia Inc.
- Responsibilities
- Laboratory and Diagnostics - ECG
- Name
- Care Access Research LLC
- Responsibilities
- Study Development/Conduct: Patient Referral, Recruitment, Screening, and/or Retention
- Name
- Veeva Systems Inc.
- Responsibilities
- sponsorDuties code: 6
Third parties
- {"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":"Data Management - Copyright licensing","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Study Development / Conduct : Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Data Management-Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Care Access Research LLC","duties_or_roles":"Study Development/Conduct: Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Health care"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Laboratory and Diagnostics - ECG","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"LabCorp Drug Development Inc","duties_or_roles":"Laboratory and Diagnostics - Central Lab","organisation_type":"Health care"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Non-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
- Frequency
- Once weekly
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
- Authorisation Status
- Placebo (not applicable)
- Frequency
- Matching the active comparator dosing schedule (once weekly) as stated for blinding/matching
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