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
09-12-2025
First CTIS Authorization Date
21-04-2026

Trial design

Randomised, eloralintide (ly3841136) administered subcutaneously once weekly (dose not specified); placebo to match ly (placebo arm).-controlled Phase III trial across 33 sites in Belgium, Czechia, Romania and others.

Randomised
Yes
Comparator
Eloralintide (LY3841136) administered subcutaneously once weekly (dose not specified); Placebo to match LY (placebo arm).
Target Sample Size
664
Trial Duration For Participant
448

Eligibility

Recruits 664 No vulnerable populations selected; participants are adults and provide informed consent; assent not applicable..

Vulnerable Population
No vulnerable populations selected; participants are adults and provide informed consent; assent not applicable.

Inclusion criteria

  • {"criterion_text":"- Be on stable incretin therapy at screening"}
  • {"criterion_text":"- Have persistent obesity or overweight defined as: o\t≥30 kg/m2 OR o\t≥27 kg/m2 with at least one existing obesity related complication at screening: \thypertension \tdyslipidemia \tobstructive sleep apnea \tcardiovascular disease, or \ttype 2 diabetes"}
  • {"criterion_text":"- Have a stable body weight (<5% body weight change) at 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)"}
  • {"criterion_text":"- Participants must NOT: Have type 1 diabetes"}
  • {"criterion_text":"- Participants must NOT: Have taken certain medications for blood sugar within 90 days prior to screening"}
  • {"criterion_text":"- Participants must NOT: Have had a serious heart condition 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 Baseline and Week 64 (Time Frame: Baseline, Week 64)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
664
Recruitment Window Months
23
Consent Approach
Informed consent obtained from adult participants. eConsent materials and landing pages are used (eConsent_Landing page, eConsent participant screenshots, ZoomHealth materials). Main ICF and optional prescreening ICF documents are provided; ICF materials available in multiple languages (English, BEFR/French (Belgium), BEDU/Dutch (Belgium), CZ/Czech, RO/Romanian).

Methods

  • Digital recruitment (Trialbee) — landing pages and digital marketing content (Trialbee digital campaign, Trialbee Landing Page, Trialbee Self_Assessment). Language/local variants present for BE (BEFR, BEDU), English, CZ, RO.
  • eConsent and remote consent tools — eConsent landing pages, eConsent participant-facing screenshots, ZoomHealth screenshots and eConsent materials.
  • Printed and offline materials — brochures, flyers, posters, patient cards, welcome/retention guides (country-specific versions referenced: BE, CZ, RO, ES).
  • Doctor referral and direct clinician outreach — Letter-Doctor-To-Patient, Letter-Doctor-Referral materials to support clinician referrals.
  • Site and sponsor websites — Meclinas website text and recruitment plan; country website text versions.

Geography

Total Number Of Sites
33
Total Number Of Participants
286

Belgium

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
35
Number Of Sites
9
Number Of Participants
71

Sites

Site Name
Imelda General Hospital
Department Name
Associatie Dialyse Endocrinologie
Contact Person Name
Chris Vercammen
Contact Person Email
chris.vercammen@imelda.be
Site Name
Emmaues
Department Name
Endocrinologie
Contact Person Name
Michel Vandenbroucke
Contact Person Email
michel.vandenbroucke@emmaus.be
Site Name
Ziekenhuis Oost-Limburg Campus St.-Jan
Department Name
Cardiology
Contact Person Name
David Verhaert
Contact Person Email
david.verhaert@zol.be
Site Name
Jan Yperman Ziekenhuis
Department Name
Departement Endocrinologie-Diabetologie
Contact Person Name
An Nollet
Contact Person Email
An.Nollet@yperman.net
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Endocrinologie
Contact Person Name
Gerd Vanhaverbeke
Site Name
Algemeen Ziekenhuis Damiaan Oostende
Department Name
Endocrinology
Contact Person Name
Marianne Kerrebrouck
Site Name
Meclinas
Department Name
Meclinas
Contact Person Name
Julie Casaer
Contact Person Email
julie.casaer@meclinas.com
Site Name
Université Libre de Bruxelles - Hôpital Erasme
Department Name
Endocrinology
Contact Person Name
Laurent Crenier
Contact Person Email
laurent.crenier@hubruxelles.be
Site Name
UZ Leuven
Department Name
Endocrinology
Contact Person Name
Roman Vangoitsenhoven

Czechia

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
25
Number Of Sites
4
Number Of Participants
62

Sites

Site Name
Diahaza s.r.o.
Department Name
diabetology
Contact Person Name
Jitka Hasalova Zapletalova
Contact Person Email
j.hasalova@email.cz
Site Name
ResTrial s.r.o.
Contact Person Name
Emilia Malicherova
Site Name
MUDr. Michala Pelikanova s.r.o.
Contact Person Name
Michala Pelikanova
Contact Person Email
pelikanova.michala@seznam.cz
Site Name
Milan Kvapil s.r.o.
Department Name
diabetology
Contact Person Name
Frantisek Loos
Contact Person Email
frankyloos@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
09-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
18
Number Of Sites
10
Number Of Participants
48

Sites

Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Liliana Marin
Contact Person Email
popaliliana@neomed.org
Site Name
Diabdana S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Dana Cosma
Contact Person Email
dana_cosma_oradea@yahoo.com
Site Name
Gama Diamed S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Amalia Thury-Burileanu
Contact Person Email
office@gamadiamed.ro
Site Name
Rinart Diab S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Anca Nicoara
Contact Person Email
a.nicoara@yahoo.com
Site Name
Clinica Korall S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Adriana Filimon
Contact Person Email
diabcaresm@gmail.com
Site Name
Easydiet S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Georgeta Vacaru
Contact Person Email
geeavacaru@ucs.ro
Site Name
Mariodiab Clinic S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Brindusa Cofaru
Contact Person Email
drcofaru@gmail.com
Site Name
Cabinet Medical Dr Geru S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Polina Geru
Contact Person Email
ninapruneageru@gmail.com
Site Name
Nutrilife S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Marlena Pascu
Contact Person Email
marlena.pascu@nutrilife.ro
Site Name
Dentosim-Queen S.R.L.
Department Name
Diebetes, nutrition and metabolic diseases
Contact Person Name
Daniela Elena Ciomos
Contact Person Email
ciomosd@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
22-12-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
137
Number Of Sites
10
Number Of Participants
105

Sites

Site Name
Clinica Juaneda S.A.
Department Name
Endocrinology
Contact Person Name
Santiago Tofe Povedano
Contact Person Email
satope2002@yahoo.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Endocrinology, Diabetes and Nutrition
Contact Person Name
Luis Alberto Vazquez Salvi
Contact Person Email
luisvazquezsalvi@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Endocrinology and nutrition
Contact Person Name
Jose Esteban Jodar Gimeno
Contact Person Email
esteban.jodar@gmail.com
Site Name
Instituto Gallego de Cirugía Ocular
Department Name
Endocrinology
Contact Person Name
Alma Maria Prieto Tenreiro
Site Name
Hospital Universitario Torrecardenas
Department Name
Endocrinology
Contact Person Name
Pedro Mezquita Raya
Contact Person Email
pmr.hut@gmail.com
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Endocrinology and nutrition
Contact Person Name
Cristobal Jesus Morales Portillo
Contact Person Email
cr.morales@hotmail.com
Site Name
Instituto Medico Quirurgico San Rafael S.A.
Department Name
Endocrinology
Contact Person Name
Alfonso Soto Gonzalez
Contact Person Email
asotog30@outlook.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Endocrinology
Contact Person Name
Margarita Rivas Fernandez
Site Name
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Contact Person Name
Alberto Aliaga Verdugo
Contact Person Email
aliaga.verdugo@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology
Contact Person Name
Andreea Ciudin Mihai
Contact Person Email
andreea.ciudin@vallhebron.cat

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"2","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Care Access Research LLC","duties_or_roles":"2","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","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
1
Frequency
Once weekly
Investigational Product Name
Placebo to match LY
Combination Treatment
Yes

Related trials

Other published trials that may interest you.