Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
200
Countries
2
Sites
14
Type 2 Diabetes
To compare HbA1c lowering efficacy of LY3457263 versus placebo at 24 weeks
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520328-27-00
- WHO UTN
- U1111-1316-9346
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Safety
To compare HbA1c lowering efficacy of LY3457263 versus placebo at 24 weeks
Conditions and MedDRA coding
Type 2 Diabetes
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-501744-15-00 | I8F-MC-GPIJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have type 2 diabetes
- Have overweight or obesity
- Have a stable body weight for three months prior to screening
- Be on a stable dose of injectable semaglutide or injectable tirzepatide for at least three months
Exclusion criteria 2
- Have type 1 diabetes
- Have taken any medications or alternative remedies for weight loss within three months prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 24]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12097133 · Product
- Active substance
- Nisotirostide
- Substance synonyms
- Nisotirotide, L-Prolyl-L-lysyl-L-prolyl-L-alfa-glutamyl-N6-[N-(17-carboxy-1-oxoheptadecyl)-L-γ-glutamyl-L-alfa-glutamyl-6-aminohexanoyl]-L-lysyl-L-prolylglycyl-L-alfa-glutamyl-L-alfa-aspartyl-L-alanyl-L-seryl-L-prolyl-L-alfa-glutamyl-L-alfa-glutamyl-L-tryptophyl-L-glutaminyl-L-arginyl-L-tyrosyl-L-tyrosyl-L-alanyl-L-alfa-glutamyl-L-leucyl-L-arginyl-L-histidyl-L-tyrosyl-L-leucyl-L-asparaginyl-L-tryptophyl-L-leucyl-L-threonyl-L-arginyl-L-glutaminyl-L-arginyl-L-tyrosinamide, LY3457263, C-terminally amidated linear polypeptide consisting of 34 amino acids with approximately 80% sequence homology to native PYY3-36
- Pharmaceutical form
- SOLUTION FOR INJECTION
- 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
Auxiliary 5
PRD12126815 · Product
- Active substance
- Tirzepatide
- 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
PRD12126814 · Product
- Active substance
- Tirzepatide
- 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
PRD12126816 · Product
- Active substance
- Tirzepatide
- 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
PRD12126817 · Product
- Active substance
- Tirzepatide
- 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
PRD12126813 · Product
- Active substance
- Tirzepatide
- 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
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 14
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | On site monitoring |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Q2 Solutions ORL-000000243
|
West Lothian, United Kingdom | Laboratory analysis |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 2 |
| Q2 Solutions ORL-000013404
|
Durham NC, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 13 |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Other |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Other |
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 5 |
| Poland | Ongoing, recruiting | 39 | 9 |
| Rest of world
Canada, United Kingdom, United States
|
— | 141 | — |
Investigational sites
Velocity Clinical Research Leipzig
N/A, Demmeringstr. 47-49, 3. OG, Leipzig
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
N/A, Gerhard-Ellrodt-Str. 19, 04249, Leipzig
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Ośrodek Badań Klinicznych "METABOLICA" Lek. Robert Witek
Ośrodek Badań Klinicznych METABOLICA Lek. Robert Witek, Najświętszej Marii Panny 9B,, 33-100, Tarnów
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
-, Ul. Przedzalniana 66, 90-338, Lodz
Legeartis Poradnie Specjalistyczne Sp. z o.o.
-, Ul. Mlynowa 17, 15-404, Bialystok
Centrum Badan Klinicznych Pi-House Sp. z o.o.
-, Ul. Na Zaspe 3, 80-546, Gdansk
Szpital Czerniakowski Sp. z o.o.
-, Ul. Ulica Stepinska 19/25, 00-739, Warsaw
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
-, Ul. Rusznikarska 17, 31-261, Cracow
NBR Polska
-, Aleja Wincentego Witosa 31, Warszawa, Warszawa
Ekamed Sp. z o.o.
-, Aleja Krasnicka 2j/u1, 20-718, Lublin
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Centrum Wsparcia Badan Klinicznych, Ul. Rudolfa Weigla 5, 53-114, Wroclaw
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 |
|---|---|---|---|---|---|
| Germany | 2025-08-07 | 2025-08-13 | |||
| Poland | 2025-08-08 | 2025-08-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-520328-27-00_Redacted | a |
| Protocol (for publication) | D4_Patient facing documents_copyright statement | 1.0 |
| 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_Informed consent_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_64251 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to Patient Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor to Patient | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-End-Of-Study | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Participation | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Screening | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing page | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_SecondaryAssessmentAndCommunication_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Werbetexte_64251 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partners_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Track Changes_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional activity_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Ancillary list | 1 |
| Subject information and informed consent form (for publication) | L2_Appreciation items | 1 |
| Subject information and informed consent form (for publication) | L2_Direction for Use IFU_Tirzepatide | 1 |
| Subject information and informed consent form (for publication) | L2_Direction for Use_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information mateiral_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information mateiral_TRZ_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Sheet_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient contact card template | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Guide | 2 |
| Subject information and informed consent form (for publication) | L2_Retention material_Visit-Card | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2024-520328-27-00_PL_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis EN 2024-520328-27-00_Redacted | a |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Germany | Acceptable 2025-06-27
|
2025-07-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-01 | Acceptable | 2025-11-25 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Germany | Acceptable | 2025-10-14 |