Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,035
Countries
5
Sites
34
Obesity
To demonstrate that eloralintide is superior to placebo for change in body weight.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 10 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523658-15-00
- WHO UTN
- U1111-1331-1119
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy, Diagnosis, Pharmacokinetic, Safety, Therapy
To demonstrate that eloralintide is superior to placebo for change in body weight.
Conditions and MedDRA coding
Obesity
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have type 2 diabetes
- Be on stable treatment for type 2 diabetes
- Have a BMI ≥ 27 kg/m2
- Have a stable body weight (<5% body weight change) for 90 days prior to screeninG
Exclusion criteria 5
- Participants must not have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)
- Have type 1 diabetes
- Have taken certain medications for blood sugar within 90 days prior to screening
- Have had a serious heart condition within 90 days prior to screening
- Have taken medications or alternative remedies intended for weight loss within 90 days prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD13082120 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082122 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082121 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082123 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- [email protected]
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- [email protected]
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| Care Access Research LLC ORL-000015894
|
Boston, MA, United States | Other |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Other |
Locations
5 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 55 | 4 |
| Germany | Ongoing, recruiting | 40 | 7 |
| Poland | Ongoing, recruiting | 80 | 8 |
| Slovakia | Ongoing, recruiting | 67 | 6 |
| Spain | Ongoing, recruiting | 55 | 9 |
| Rest of world
Taiwan, Argentina, Japan, Mexico, Korea, Democratic People's Republic of, China
|
— | 738 | — |
Investigational sites
Diabet2 s.r.o.
Diabetologická a interní ambulance, Revolucni 765/19, Stare Mesto, Prague 1
MUDr. Miroslav Koliba s.r.o.
NA, Bieblova 410/2, Moravska Ostrava, Ostrava
MUDr. Tomáš Edelsberger
Diabetologie, Náměstí Minoritů 86/7, 794 01, Krnov
MUDr. Jana Parkányiová
Endokrinologie a diabetologie, Revoluční 765/19,, 110 00, Praha 1
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
Diabetespraxis Dr. Braun
N/A, Breite Str. 41, Berlin, Berlin
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
N/A, Düesbergweg 128, Nordrhein-Westfalen, Münster
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Diabetologische Schwerpunktpraxis
N/A, Wilhelmstrasse 25, Nordrhein-Westfalen, Bünde
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
NA, Ul. Rusznikarska 17, 31-261, Cracow
Ekamed Sp. z o.o.
NA, Aleja Krasnicka 2j/u1, 20-718, Lublin
Ambulatorium Sp. z o.o.
NA, Ul. Topolowa 28, 82-300, Elblag
Centrum Medyczne Neuromed Sp. z o.o.
NA, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Osrodek Diabetologiczny Popula Elzbieta Poplawska Grazyna Laszewska Sp. j.
NA, Al. Jozefa Pilsudskiego 4a/1, 15-369, Bialystok
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
NA, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
NA, Ul. 3 Maja 13/15, 41-800, Zabrze
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
NA, Ul. Przedzalniana 66, 90-338, Lodz
MediVet s.r.o.
DIAMA Diabetes Center, Nadrazna 23, 901 01, Malacky
B-Medical s.r.o.
N/A, Mlaka 1258, Namestovo, Žilinský kraj
DIA-MED CENTRUM s.r.o.
N/A, M.R Stefanika 811, 020 01, Puchov
Diacrin s.r.o.
N/A, Jelsova 3086/1, Nove Mesto, Bratislava
Funkystuff s.r.o.
N/A, J. Krala 8760/3, 940 02, Nove Zamky
Medi-Dia s.r.o.
N/A, Namestie Slobody 65, 083 01, Sabinov
Hospital Nisa Sevilla Aljarafe
Endocrinology, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Virgen De La Victoria
Endocrinology and nutrition, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Centro Médico Compostela
endocrinología, Rúa do Hórreo, 13
Hospital Clinic De Barcelona
Endocrinology and metabolism, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Regional De Malaga
Endocrinology and nutrition, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitari Vall D Hebron
Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Ruber Juan Bravo
Endocrinology and Matabolism, Calle De Juan Bravo 49, 28006, Madrid
Hospital Universitario De La Ribera
Endocrinology, Carretera Corbera Km 1, 46600, Alzira
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-04-10 | 2026-04-14 | |||
| Germany | 2026-04-10 | 2026-04-14 | |||
| Poland | 2026-04-10 | 2026-04-13 | |||
| Slovakia | 2026-04-10 | 2026-04-15 | |||
| Spain | 2026-04-10 | 2026-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 114 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol addendum EU_2025-523658-15-00_Redacted | 2.0 |
| Protocol (for publication) | D1_Protocol_2025-523658-15-00_Redacted | b |
| Protocol (for publication) | D4_Patient Documents Copyright_ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_List of sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor-to-Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_ES | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter doctor to patient_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_ES | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Digital Marketing Content_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Global Privacy Policy_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Landing Page_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Overview Supplementary Information_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Secondary Assessment_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Self_Assessment_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Poster_Master | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF CGM Addendum ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_v2_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Additional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_addendum_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CGM addendum_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Addendum ICF_YDAF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_YDAF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partnerparticipant | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of eating well | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of healthy connections | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of managing stress | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of moving more | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days to better sleep | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Accu-chek instant F manual | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT GI-AE brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT HbA1c brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT hypo awareness brochure | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT study connect pt_Ed 1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT study connect pt_ed 2 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT study connect pt_Ed 3 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT study connect pt_Ed 4 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT supportive partner guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CWM health journey support | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CWM obesity infrographic | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CWM shopping list | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dexcom_Participant Guide_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_End of study letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP CT phases | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP understanding randomization | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP what are CT | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP what is a placebo | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flyer | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_G7 CGM User guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_G7 CGM Web user guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GI-AE-Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_instructions for use_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Doctor-to-Patient_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant guide_Dexcom 7 hybrid | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_PrivacyStatement_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_Screenshots_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_TermsofService_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment brochure_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment flyer_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Recruitment poster_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study connect pt | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee campaign overview_supp info | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee digital marketing content | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee global privacy policy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee landing page_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee secondary assessment_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trialbee self-assessment_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit card_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_What Are Clinical Trials | 1 |
| Subject information and informed consent form (for publication) | L2_Participant Guide_Dexcom | 1 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Global Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Overview Supplementary Information | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Self_Assessment_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Digital Marketing Content | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Landing Page_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Secondary Assessment_Redacted | 1 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure_PL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis SK_2025-523658-15-00_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523658-15-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2025-523658-15-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-523658-15-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol_a_Synopsis_2025-523658-15-00_PL_Redacted | a |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-21 | Germany | Acceptable 2026-03-23
|
2026-03-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-02 | Acceptable 2026-03-23
|
2026-04-02 |