Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
254
Countries
3
Sites
25
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
- 13 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523657-34-00
- WHO UTN
- U1111-1331-0530
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Diagnosis, Efficacy, Therapy, Pharmacodynamic, Safety
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 obesity or overweight
- If overweight, must also have one of the following: high blood pressure, high cholesterol, obstructive sleep apnea or heart disease
- Have a stable body weight (<5% body weight change) for 90 days prior to screening
- Have at least one self-report of an unsuccessful dietary effort to lose weight
Exclusion criteria 4
- Have type 1 diabetes or type 2 diabetes
- Have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)
- Have had a serious heart condition within 90 days prior to screening
- Have taken medications or alternative remedies for weight loss within 90 days of 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
PRD13082123 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- 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 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082120 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- 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 Other
- Max total dose
- 0 Other
- 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
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| 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 |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Other |
| Care Access Research LLC ORL-000015894
|
Boston, MA, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
Locations
3 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 99 | 3 |
| Germany | Ongoing, recruiting | 62 | 13 |
| Poland | Ongoing, recruiting | 93 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Anima
ANIMA Research Loc. 1, Alkerstraat 28, 3570, Alken
Kormont
Vercruysse, Kwaremontplein 45, 9690, Kluisbergen
Jessa Ziekenhuis
Cardiology Loc. 1, Stadsomvaart 11, 3500, Hasselt
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Praxis Sauter & Vorbach
N/A, Herrenstrasse 22 - 24, 88239, Wangen im Allgäu
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Universitätsstudienzentrum für Stoffwechselerkrankungen, 43 Blasewitzer Straße, EG, Dresden
Medizentrum Essen Borbeck
N/A, Huelsmannstrasse 6, Borbeck, Essen
CRS Clinical Research Services Management GmbH
N/A, Grenadierstrasse 1, Neckarstadt, Mannheim
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
N/A, Am Wall Süd 20, 49808, Lingen
BAG Drs. Med. Quist PartG
N/A, Haifa-Allee 20, 1st Floor Clinical trial center, Mainz
Diabeteszentrum Hamburg West
N/A, Beselerstrasse 2a, 22607, Hamburg
Zentrum fur klinische Forschung - Köln
N/A, Berliner Strasse 895, 1. OG, Köln
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
MVZ Hausaerzte Grossenbaum GmbH
N/A, Grossenbaumer Allee 113, Grossenbaum, Duisburg
Ekamed Sp. z o.o.
NA, Aleja Krasnicka 2j/u1, 20-718, Lublin
Centrum Zdrowia Metabolicznego Pawel Bogdanski
NA, ul. Nowina 14F, 60-589, Poznan
Nzoz Zdrowie Osteo-Medic
NA, ul. Wiejska 81, 15-351, Bialystok
Terpa Sp. z o.o. sp.k.
NA, Ul. Pogodna 34, 20-333, Lublin
Pracownia Badan Klinicznych SALUS
NA, ul. Ołtaszyńska 92c/3, 53-034, Wrocław
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
NA, Ul. Rusznikarska 17, 31-261, Cracow
Legeartis Poradnie Specjalistyczne Sp. z o.o.
NA, Ul. Mlynowa 17, 15-404, Bialystok
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
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 |
|---|---|---|---|---|---|
| Belgium | 2026-04-13 | 2026-04-21 | |||
| Germany | 2026-04-13 | 2026-04-14 | |||
| Poland | 2026-04-13 | 2026-04-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 100 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523657-34-00 redacted | a |
| Protocol (for publication) | D1_Protocol addendum EU 2025-523657-34-00_Redacted | 5 |
| Protocol (for publication) | D4_Patient Facing Document_Patient Documents Copyright | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_Understanding-Randomization | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_What-Are-Clinical Trials | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_What-Is-A-Placebo | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Investigator Forst_CRS | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Landing Page_Investigator Forst_CRS | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor Referral_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor Referral_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor Referral_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor to Patient_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor to Patient_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor to Patient_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Digital Marketing Content_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Global Privacy Policy_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Landing Page_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Landing Page_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_OverviewSupplementaryInformation_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Secondary Assessment_PL_Redacted | 1.0 |
| 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 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trialbee_Supplementary Information | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Sponsor_Statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIF and ICF_Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted_English | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_YDAG_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner ICF | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure_Master_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_English_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_HbA1c-Brochure-OUS_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Landing page_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Landing page_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Landing page_English_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Participant Facing Screenshots_BEDU_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Participant Facing Screenshots_BEFR_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Participant Facing Screenshots_English_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Privacy Policy_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Privacy Policy_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Privacy Policy_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Security and Privacy_BEDU_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Security and Privacy_BEFR_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Security and Privacy_Eng_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Submission Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_Clinical-Trial-Phases_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_Understanding-Randomization_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_What-Are-Clinical Trials_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flyer_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_English_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter-Doctor-to-Patient_Master_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_PrivacyStatement_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_Screenshots_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Polish_ZoomHealth_TermsofService_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Poster_Master_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Zoom_Privacy Statement_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Privacy Statement_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Privacy Statement_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Terms Of Service_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Terms Of Service_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Terms Of Service_English | 1.0 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1.0 |
| Subject information and informed consent form (for publication) | L3_ZoomHealth Screenshots | 1 |
| Subject information and informed consent form (for publication) | L3_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L3_ZoomHealth_RegulatorySubmission_CoverLetter | 1 |
| Subject information and informed consent form (for publication) | L3_ZoomHealth_TermsofService | 1 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523657-34-00_BEDE_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523657-34-00_BEDU_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523657-34-00_BEFR_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523657-34-00_English_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523657-34-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_Redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-24 | Germany | Acceptable 2026-03-26
|
2026-03-27 |