Clinical trial • Phase III • Endocrinology
LY3841136 SODIUM for Obesity|Overweight
Phase III trial of LY3841136 SODIUM for Obesity|Overweight.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity|Overweight
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 24-11-2025
- First CTIS Authorization Date
- 27-03-2026
Trial design
Randomised, placebo to match eloralintide (placebo to match ly) - dose and schedule not specified in the ctis record-controlled Phase III trial across 25 sites in Belgium, Germany, Poland.
- Randomised
- Yes
- Comparator
- Placebo to match Eloralintide (Placebo to match LY) - dose and schedule not specified in the CTIS record
- Target Sample Size
- 254
- Trial Duration For Participant
- 448
Eligibility
Recruits 254 isVulnerablePopulationSelected: false; trial enrols adult participants only. Informed consent is obtained from participants. eConsent materials and subject information / ICF documents are provided (documents available in English, Belgian Dutch (BEDU), Belgian French (BEFR) and Polish)..
- Vulnerable Population
- isVulnerablePopulationSelected: false; trial enrols adult participants only. Informed consent is obtained from participants. eConsent materials and subject information / ICF documents are provided (documents available in English, Belgian Dutch (BEDU), Belgian French (BEFR) and Polish).
Inclusion criteria
- {"criterion_text":"- Have obesity or overweight\n- If overweight, must also have one of the following: high blood pressure, high cholesterol, obstructive sleep apnea or heart disease\n- Have a stable body weight (<5% body weight change) for 90 days prior to screening\n- Have at least one self-report of an unsuccessful dietary effort to lose weight"}
Exclusion criteria
- {"criterion_text":"- Have type 1 diabetes or type 2 diabetes\n- Have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)\n- Have had a serious heart condition within 90 days prior to screening\n- Have taken medications or alternative remedies for weight loss within 90 days of screening"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64","definition_or_measurement_approach":"Percent change in body weight from baseline to Week 64 (primary timepoint listed as Baseline and Week 64)."}
Recruitment
- Digital Remote Recruitment
- True - digital methods include Trialbee digital marketing and landing pages, online self-assessment tools, Trialbee marketing content, and eConsent/ZoomHealth remote eConsent platforms and participant-facing eConsent pages (documents available in English, BEDU, BEFR, PL).
- Planned Sample Size
- 254
- Recruitment Window Months
- 47
- Consent Approach
- Informed consent obtained from adult participants. eConsent procedures and participant information/ICF documents are provided (including eConsent landing pages and participant-facing screenshots). Subject information and ICF documents are available in English, Belgian Dutch (BEDU), Belgian French (BEFR) and Polish as indicated by the uploaded documents.
Methods
- Digital recruitment and marketing via Trialbee (landing pages, digital marketing content, self-assessment and landing pages) targeted to potential participants (documents and marketing content available for Belgium, Germany, Poland).
- Investigator/doctor referral materials: Letters from doctor to patient and doctor referral letters (country-specific versions present).
- Printed materials and outreach: Brochures, flyers, posters for participant recruitment (country-specific versions).
- Site-based recruitment and patient screening conducted by local sites and vendor partners (Care Access Research LLC and other CRO/vendor partners listed).
- eConsent and remote recruitment/consent workflows using eConsent landing pages and ZoomHealth materials (participant-facing eConsent screenshots and privacy/security documents present).
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 254
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-03-2026
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 8
- Number Of Sites
- 3
- Number Of Participants
- 99
Sites
- Site Name
- Jessa Ziekenhuis
- Department Name
- Cardiology Loc. 1
- Principal Investigator Name
- Guido Claessen
- Principal Investigator Email
- Guido.Claessen@jessazh.be
- Contact Person Name
- Guido Claessen
- Contact Person Email
- Guido.Claessen@jessazh.be
- Site Name
- Anima
- Department Name
- ANIMA Research Loc. 1
- Principal Investigator Name
- Hilde Bollen
- Principal Investigator Email
- hilde.bollen@animaresearch.com
- Contact Person Name
- Hilde Bollen
- Contact Person Email
- hilde.bollen@animaresearch.com
- Site Name
- Kormont
- Department Name
- Vercruysse
- Principal Investigator Name
- Klaas Vercruysse
- Principal Investigator Email
- klaas.vercruysse@telenet.be
- Contact Person Name
- Klaas Vercruysse
- Contact Person Email
- klaas.vercruysse@telenet.be
Germany
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 29
- Number Of Sites
- 13
- Number Of Participants
- 62
Sites
- Site Name
- InnoDiab Forschung GmbH
- Principal Investigator Name
- Thomas Schürholz
- Principal Investigator Email
- thomas.schuerholz@innodiab.de
- Contact Person Name
- Thomas Schürholz
- Contact Person Email
- thomas.schuerholz@innodiab.de
- Site Name
- Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
- Principal Investigator Name
- Andreas Staudenmeyer
- Principal Investigator Email
- staudenmeyer@diabetes-lingen.de
- Contact Person Name
- Andreas Staudenmeyer
- Contact Person Email
- staudenmeyer@diabetes-lingen.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
- Site Name
- Zentrum fur klinische Forschung - Köln
- Principal Investigator Name
- Bastian Kirsch
- Principal Investigator Email
- b.kirsch@zentrum-fuer-klinische-forschung.de
- Contact Person Name
- Bastian Kirsch
- Contact Person Email
- b.kirsch@zentrum-fuer-klinische-forschung.de
- Site Name
- Ambenet GmbH Das Ambulante Behandlungsnetz
- 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
- Medizentrum Essen Borbeck
- Principal Investigator Name
- Axel Schaefer
- Principal Investigator Email
- axel.schaefer@mzeb.de
- Contact Person Name
- Axel Schaefer
- Contact Person Email
- axel.schaefer@mzeb.de
- Site Name
- BAG Drs. Med. Quist PartG
- Principal Investigator Name
- Sven Roy Quist
- Principal Investigator Email
- s.quist@dermatologie-quist.de
- Contact Person Name
- Sven Roy Quist
- Contact Person Email
- s.quist@dermatologie-quist.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
- Department Name
- Universitätsstudienzentrum für Stoffwechselerkrankungen
- Principal Investigator Name
- Nikolaos Perakakis
- Principal Investigator Email
- nikolaos.perakakis@uniklinikum-dresden.de
- Contact Person Name
- Nikolaos Perakakis
- Contact Person Email
- nikolaos.perakakis@uniklinikum-dresden.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
- Praxis Sauter & Vorbach
- Principal Investigator Name
- Joachim Sauter
- Principal Investigator Email
- joachim@dr-sauter-wangen.de
- Contact Person Name
- Joachim Sauter
- Contact Person Email
- joachim@dr-sauter-wangen.de
- Site Name
- Diabeteszentrum Hamburg West
- Principal Investigator Name
- Jens Aberle
- Principal Investigator Email
- aberle@dzhw.de
- Contact Person Name
- Jens Aberle
- Contact Person Email
- aberle@dzhw.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
- CRS Clinical Research Services Management GmbH
- Principal Investigator Name
- Thomas Forst
- Principal Investigator Email
- thomas.forst@crs-group.de
- Contact Person Name
- Thomas Forst
- Contact Person Email
- thomas.forst@crs-group.de
Poland
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 9
- Number Of Participants
- 93
Sites
- 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
- NZOZ ZDROWIE OSTEO-MEDIC
- Principal Investigator Name
- Katarzyna Wasilewska
- Principal Investigator Email
- k.wasilewska.osteo@gmail.com
- Contact Person Name
- Katarzyna Wasilewska
- Contact Person Email
- k.wasilewska.osteo@gmail.com
- 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
- 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
- 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
- Pracownia Badan Klinicznych SALUS
- Principal Investigator Name
- Katarzyna Madziarska
- Principal Investigator Email
- maciej.rabczynski@pbks.com.pl
- Contact Person Name
- Katarzyna Madziarska
- Contact Person Email
- maciej.rabczynski@pbks.com.pl
- Site Name
- Legeartis Poradnie Specjalistyczne Sp. z o.o.
- Principal Investigator Name
- Anna Modzelewska
- Principal Investigator Email
- anamed@onet.eu
- Contact Person Name
- Anna Modzelewska
- Contact Person Email
- anamed@onet.eu
- Site Name
- Terpa Sp. z o.o. sp.k.
- Principal Investigator Name
- Beata Matyjaszek-Matuszek
- Principal Investigator Email
- bmm@2com.pl
- Contact Person Name
- Beata Matyjaszek-Matuszek
- Contact Person Email
- bmm@2com.pl
- Site Name
- CENTRUM ZDROWIA METABOLICZNEGO PAWEL BOGDANSKI
- Principal Investigator Name
- Paweł Bogdański
- Principal Investigator Email
- pawelbogdanski73@gmail.com
- Contact Person Name
- Paweł Bogdański
- Contact Person Email
- pawelbogdanski73@gmail.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Name
- Iqvia Inc.
- Responsibilities
- Laboratory and Diagnostics
- Name
- CRS Clinical Research Services Management GmbH
- Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Name
- Care Access Research LLC
- Responsibilities
- Patient Screening, Recruitment, and/or Retention
Third parties
- {"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":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","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 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":"Iqvia Inc.","duties_or_roles":"Laboratory and Diagnostics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","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
- Frequency
- Once weekly
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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