Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,000
Countries
2
Sites
14
Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes who have obesity or overweight (J1I-MC-GZBK master protocol)
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
- 31 Aug 2023 → 17 Feb 2026
- Decision date (initial)
- 2023-08-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503658-11-00
- WHO UTN
- U1111-1287-2472
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes who have obesity or overweight (J1I-MC-GZBK master protocol)
Conditions and MedDRA coding
Type 2 Diabetes
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
- Be Overweight or Have Obesity
- Have Type 2 Diabetes
- Are on stable treatment for Type 2 Diabetes for at least 90 days before starting study.
- History of unsuccessful weight loss.
Exclusion criteria 5
- Have a self-reported or documented change in body weight >5 kg within 90 days before screening.
- Have a prior or planned surgical treatment for obesity.
- Have Type 1 diabetes
- Have had 1 episode of severe hypoglycemia or hypoglycemia unawareness ≤6 months before screening.
- Have acute or chronic hepatitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Weight
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10345209 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345551 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345188 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345489 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345508 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(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 11
| Organisation | City, country | Duties |
|---|---|---|
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Brightech International, LLC ORL-000001391
|
Somerset, NJ, United States | Code 10 |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 113 | 6 |
| Spain | Ended | 122 | 8 |
| Rest of world
India, Australia, United States, China, Taiwan, Mexico, Korea, Republic of
|
— | 765 | — |
Investigational sites
Nutrilife S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Gama Diamed S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, T S Saveanu Nr 1, 905500, Mangalia
Easydiet S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, Strada Alexandrescu Grigore Nr 80 Sector 1, 010627, Bucharest
Mediab S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Diabdana S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, Calea Republicii Nr 77, 410147, Oradea
Sc Cmi Dr. Pletea Noemi S.R.L.
Diabetes, Nutrition and Metabolic Disease Department, Strada Stadionului Nr 3a Parter, 600154, Bacau
Hospital Universitario Regional De Malaga
Endocrinology and Nutrition, Avenida De Carlos De Haya S/n, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Endocrinology and Nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Nisa Sevilla Aljarafe
Metabolic Health Unit -Diabetes and overweight, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Torrecardenas
Endocrinology, Calle Paraje Torrecardenas S/n, 04009, Almería
Hospital Universitario Principe De Asturias
Endocrinology and Nutrition, Carretera Meco S/n, 28805, Alcala De Henares
Leon University Hospital
Endocrinology and Metabolism, C Altos De Nava S/n, 24071, Leon
Hospital Universitario Ramon Y Cajal
Internal Medicine, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Virgen De La Victoria
Endocrinology and Nutrition, Calle Del Arroyo Teatinos S N, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Romania | 2023-08-31 | 2026-02-17 | 2023-09-07 | 2024-06-07 | |
| Spain | 2023-09-04 | 2026-02-11 | 2023-09-05 | 2024-06-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 62 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503658-11-00_Redacted | b |
| Protocol (for publication) | D4_Patient facing documents_copyright | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_CWM_Digital_Ads__Comorbidities__Master_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_CWM_Digital_Ads_General_Chronic_Weight_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_CWM_Program_Database_Messaging_Master | 3.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_CWM_Program_Website_Policies_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_CWM_Screener_Edition 2_Master_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Contact card | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Flyer_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Letter Doctor Referral | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Participant letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appreciation items | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BROCHURE-DG_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC__WS_Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Search Ads_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Chronic_Weight | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Obesity | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Program | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Video Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBK_Appreciation Items | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBK_Patient_Messaging | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBK_Website | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBK_Website_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HYPOGLYCAEMIA-AWARENESS-BROCHURE_V2_21MAR2023_RO | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SHOPPING-LIST_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_STUDY-GUIDE_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_STUDY-GUIDE-DG_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_VISIT-CARD_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Thank-You-Participation_Master | 2 |
| Recruitment arrangements (for publication) | K3_List of participant sites | 1 |
| Subject information and informed consent form (for publication) | Blanket Statement - Document not published anymore_30Nov2023 | 1.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Summary of Changes_RO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_RO_Greenphire ICF_V2_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Pregnant Partner Consent | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Instructions for Use | 1 |
| Subject information and informed consent form (for publication) | L2_Other patient material_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_ClinCard Cardholder FAQ | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_ClinCard information | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_ClinCard Msg Templates | 6 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_Details | 1 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire materials_Fee_Schedule | 1 |
| Subject information and informed consent form (for publication) | L4_Annex 3 | 1 |
| Subject information and informed consent form (for publication) | L4_Annex 7 | 1 |
| Subject information and informed consent form (for publication) | L5_Clinical Trial Ancillary Supply List | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-503658-11_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-503658-11_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2023-503658-11_Redacted | 1.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | Spain | Acceptable 2023-08-21
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-11 | Acceptable | 2023-11-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-12 | Acceptable | 2024-02-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-20 | Spain | Acceptable | 2024-01-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-07 | Spain | Acceptable | 2024-03-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-29 | Acceptable | 2024-05-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-29 | Spain | Acceptable | 2024-04-30 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-25 | Spain | Acceptable 2025-05-30
|
2025-05-30 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-04 | Spain | Acceptable | 2026-01-19 |