Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
120
Countries
2
Sites
7
Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
To compare the effect of LY3437943 to placebo on mGFR from baseline to Week 24
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
- 7 May 2024 → 22 Oct 2025
- Decision date (initial)
- 2023-11-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504583-42-00
- WHO UTN
- U1111-1289-9468
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Safety, Pharmacokinetic, Efficacy, Pharmacogenomic, Pharmacogenetic, Pharmacodynamic
To compare the effect of LY3437943 to placebo on mGFR from baseline to Week 24
Conditions and MedDRA coding
Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Be overweight.
- Have no Type 2 diabetes or has Type 2 diabetes and treated with diet and exercise only with stable doses of up to 3 oral diabetic medications.
- Have been diagnosed with CKD.
Exclusion criteria 4
- Have a change in body weight greater than 11 pounds.
- Have Type 1 Diabetes
- Have acute or chronic hepatitis
- Have a history of cancer within 5 years before screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in GFR (mL/min/m2 ) using iohexol clearance
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10345154 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 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
Auxiliary 1
SCP1841905 · ATC
- Active substance
- Iohexol
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 3235 mg milligram(s)
- Max total dose
- 9705 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB02 — IOHEXOL
- 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| R&G US Inc. ORG-100048358
|
North Potomac, United States | Code 10 |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Antaros Medical AB ORG-100039055
|
Molndal, Sweden | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 11 | 4 |
| Spain | Ended | 7 | 3 |
| Rest of world
United States, Canada, United Kingdom
|
— | 102 | — |
Investigational sites
Azienda Ospedaliera Papa Giovanni XXIII
SC Malattie Endocrine-Diabetologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Pisana
U.O. Medicina Interna I Universitaria, Via Roma 67, 56126, Pisa
Ospedale San Raffaele S.r.l.
Unità Cardio-Metabolica e Trials Clinici, Via Olgettina 60, 20132, Milan
Centro Cardiologico Monzino S.p.A.
diabetology, Via Carlo Parea 4, 20138, Milan
Hospital Clinico Universitario De Valencia
Nephrology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Dr Peset Aleixandre
Nephrology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endocrinology, Calle Alejo Fernandez 9, 41003, Sevilla
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 |
|---|---|---|---|---|---|
| Italy | 2024-05-07 | 2025-10-21 | 2024-06-04 | 2025-04-08 | |
| Spain | 2024-05-07 | 2025-09-17 | 2024-05-15 | 2025-04-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 46 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504583-42-00_Redacted | c |
| Protocol (for publication) | D1_Protocol 2023-504583-42-00_redacted | d |
| 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 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_GGG_GI-AE-REFERENCE-CARD_V3_20JUN2023_IT | 3.0 |
| Recruitment arrangements (for publication) | K2_GGG_HYPOGLYCAEMIA-ONE-PAGE-AWARENESS-BROCHURE_V2_21MAR2023_IT | 2.0 |
| Recruitment arrangements (for publication) | K2_GZBU_THANK-YOU-PARTICIPATION-EU_MASTER_V1_31MAR2023_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_GZBU_TRIAL-AWARENESS-BROCHURE-EU_MASTER_V1_31MAR2023_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_GZBU_VISIT-CARD-EU_MASTER_V1_31MAR2023_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_LETTER-DOCTOR-REFERRAL-EU_MASTER | 1 |
| Recruitment arrangements (for publication) | K2_POSTER-EU_MASTER | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material _GZBU_Trial Referral Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC_ WS_Script_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Database_Messaging_Master | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Copy_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Policies_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_Edition 2_Master | 7.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_DG_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBU_Database_ Patient_Messaging_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBU_Website_Copy_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Guide_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Awareness brochure_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_DG_ES | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_ES | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit Card_ES | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GP Letter_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_CONTACT-CARD-EU_MASTER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU-VIAL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_STUDY-GUIDE-EU_MASTER | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_THANK-YOU-SCREENING-EU_MASTER | 1.0 |
| Synopsis of the protocol (for publication) | D1 _Please disregard this document_ Reference INC0112457 | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-504583-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-504583-42_Redacted | d |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_IT_2023-504583-42_Redacted | c |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-25 | Italy | Acceptable with conditions 2023-11-10
|
2023-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-24 | Italy | Acceptable 2024-04-15
|
2024-04-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-22 | Italy | Acceptable 2024-04-15
|
2024-04-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-22 | Italy | Acceptable | 2024-06-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-28 | Acceptable | 2024-06-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-08 | Acceptable | 2024-12-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-12 | Italy | Acceptable 2025-05-08
|
2025-05-12 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-12 | Italy | Acceptable 2025-05-08
|
2025-09-12 |