Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
888
Countries
2
Sites
24
Type 2 Diabetes
To demonstrate that orforglipron is noninferior to dapagliflozin in glycemic control.
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
- 14 Mar 2024 → 27 Sep 2025
- Decision date (initial)
- 2024-02-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507206-13-00
- WHO UTN
- U1111-1296-1507
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To demonstrate that orforglipron is noninferior to dapagliflozin in glycemic control.
Conditions and MedDRA coding
Type 2 Diabetes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have Type 2 diabetes.
- Have been on stable diabetes treatment with metformin 90 days before study start through randomization.
- Have not lost or gained body weight for at least 90 days prior to baseline and agree to not start an intensive diet or exercise program during the study with the intent to lose body weight other than lifestyle and/or dietary measures for diabetes treatment.
Exclusion criteria 4
- Have Type 1 Diabetes
- Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to baseline.
- Have had congestive heart failure.
- Have had heart attack, stroke or hospitalized for congestive heart failure
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Hemoglobin A1c (HbA1c)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD10193663 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193676 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193667 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193655 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193651 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193674 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP153586 · ATC
- Active substance
- Dapagliflozin
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — DAPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SCP135808 · ATC
- Active substance
- Metformin
- Substance synonyms
- DIMETHYLDIGUANIDE
- Route of administration
- ORAL USE
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 6
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Clario ORL-000001148
|
Philadelphia, United States | E-data capture |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
Locations
2 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 75 | 12 |
| Poland | Ended | 191 | 12 |
| Rest of world
United States, Taiwan, Mexico, China
|
— | 622 | — |
Investigational sites
Diabetologikum DDG Ludwigshafe
N/A, Ludwigsplatz 9, 67059, Ludwigshafen
RED Oncology GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Zentrum für klinische Studien
N/A, Hauptstraße 98, 66386, St. Ingbert
Zentrum für klinische Forschung
N/A, Berliner Str. 895, 51069, Köln
Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer
N/A, Bahnhofstrasse 1a, Saarland, Rehlingen
Praxis Dr. med. Staudenmeyer
N/A, Am Wall Süd 20, 49808, Lingen
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Medizentrum Essen Borbeck
N/A, Huelsmannstrasse 6, Borbeck, Essen
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
Diabetes- und Stoffwechselpraxis Bochum
N/A, In der Hönnebecke 80, 44869, Bochum
CRS Clinical Research Services Management GmbH
N/A, Grenadierstrasse 1, Neckarstadt, Mannheim
Centermed Sp. z o.o.
No Department, Ul. Weteranow 46, 20-044, Lublin
Niepubliczny Zakład Opieki Zdrowotnej „Przychodnia z Sercem
No Department, ul. Bartłomieja Chowańca 4, 32-615, Grojec
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
No Department, ul. 3 Maja 13-15, 41-800, Zabrze
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
No Department, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
No Department, Ul. Rusznikarska 17, 31-261, Cracow
Ekamed Sp. z o.o.
No Department, Aleja Krasnicka 2j/u1, 20-718, Lublin
Centrum Badań Klinicznych Piotr Napora Lekarze sp.p
No Department, ul. Długosza 4;, 50-162, Wrocław
Zdrowie Osteo-Medic
No Department, ul. Wiejska 81,, 15-351, Białystok
Clinical Best Solutions Sp. z o.o. S.K.
No Department, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Specderm Poznanska Sp. j.
No Department, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
No Department, Ul. Przedzalniana 66, 90-338, Lodz
Centrum Medyczne Diabetika
No Department, ul. Focha 12/4;, 26-600, Radom
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 | 2024-03-14 | 2025-09-26 | 2024-03-19 | 2024-11-15 | |
| Poland | 2024-03-14 | 2025-09-24 | 2024-03-22 | 2024-11-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 68 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507206-13-00_Redacted | b |
| Protocol (for publication) | D4_Patient Documents Copyright Template | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Subject_Diary_4 Point SMBG_V1_GZGV | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GZGV | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GZGV_EN | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GZGV_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Poster_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_General_T2D_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC_WS_Script_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Database_Messaging_Master_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Copy_Master_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Policies_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_Edition 2_Master_Redacted | 6 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Type_2_Diabetes_Metformin_Digital_Ads_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZGV_ACHIEVE-2_Patient_Messaging_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZGV_ACHIEVE-2_Website_Copy_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster-EU_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Subject Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Subject Advertisement_site Forst_CRS | 1 |
| Recruitment arrangements (for publication) | K3_List of planned sites_Poland | 2 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangments_Informed consent and patient recruitment procedure PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Pregnant_Partner_PL_GZGV | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Pregnant_Partner_PL_GZGV_track v2 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Prescreening_PL_GZGV | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Prescreening_PL_track_v2_GZGV | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZGV_Main ICF DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZGV_Pre-Screening Addendum_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_PL_GZGV_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_PL_v2 track GZGV_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Ancillary supply list | 1 |
| Subject information and informed consent form (for publication) | L2_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L2_GZGV_patient reimbursement GREENPHIRE_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_GZGV_patient reimbursement_THUROCZY_Fahrtkostenformular_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_GZGV_patient reimbursement_THUROCZY_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other material_EC_packet_w_Data_Privacy_as_applied_to_GP_v9.0 | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other material_EU Generic ClinCard (v3.0 April 2019) | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other material_Greenphire ClinCard Msg Templates - ROW (v6.0 Feb 2018) | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other material_Greenphire_ClinCard_Card_Carrier_EU_V3.0 | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other material_Greenphire_ClinCard_Cardholder_FAQ_EU_V3.0 | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other material_Greenphire_Fee_Schedule_V4.0 | 4.0 |
| Subject information and informed consent form (for publication) | L2_other materials_EC_packet_Data_Privacy_as_applied_to_GP | 8 |
| Subject information and informed consent form (for publication) | L2_other materials_Greenphire ClinCard Msg Templates - ROW | 6 |
| Subject information and informed consent form (for publication) | L2_other materials_Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_other materials_Greenphire_ClinCard_Card_Carrier_EU | 3 |
| Subject information and informed consent form (for publication) | L2_other materials_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_other materials_Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card GZGV | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items_GZGV | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Ancillary Supply List_GZGV | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZGV_Study Guide_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZGV_Visit Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_GZGV_Letter Doctor Referral | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_LTFQ_WS_Paper_German-Worldwide_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_LTFQ_WS_Paper_Polish_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Prescreening Questionnaire_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Prescreening Questionnaire_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_WS_Paper_German-Worldwide_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L2_Patient Card Template | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Guide-EU_Master_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention material_Visit-Card-EU_Master | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dapagliflozin_Forxiga AstraZeneca | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2023-507206-13_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2023-507206-13_Track changed_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-507206-13-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_v2_PL 2023-507206-13-00_track_Redacted | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-11 | Germany | Acceptable with conditions 2024-02-09
|
2024-02-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-20 | Germany | Acceptable with conditions 2024-02-09
|
2024-02-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-15 | Germany | Acceptable 2024-04-25
|
2024-04-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-02 | Germany | Acceptable 2024-08-27
|
2024-08-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-18 | Acceptable | 2024-11-26 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-12 | Acceptable | 2024-12-12 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-23 | Acceptable | 2025-04-23 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-16 | Germany | Acceptable | 2025-07-16 |