A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)

2023-506082-60-00 Protocol I8F-MC-GPIG Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 28 Feb 2023 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 6 sites · Protocol I8F-MC-GPIG

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 140
Countries 3
Sites 6

Chronic Kidney Disease

To compare the effect of tirzepatide MTD QW and placebo on kidney oxygenation after 52 weeks of treatment, in participants with and without T2D

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Phenomena and Processes [G] - Metabolism [G03]
Trial duration
28 Feb 2023 → ongoing
Decision date (initial)
2024-01-02
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-506082-60-00
EudraCT number
2021-005273-47
WHO UTN
U1111-1294-9394

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacogenetic, Pharmacokinetic, Pharmacodynamic, Pharmacogenomic

To compare the effect of tirzepatide MTD QW and placebo on kidney oxygenation after 52 weeks of treatment, in participants with and without T2D

Conditions and MedDRA coding

Chronic Kidney Disease

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 3

  1. Have obesity or overweight
  2. Have chronic kidney disease
  3. Half of participants must have type 2 diabetes and half of participants must not have type 2 diabetes

Exclusion criteria 3

  1. Have a history of diabetic eye diseases
  2. Have gained weight within 90 days before study
  3. Have a history of unstable or severe kidney disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from Baseline in Kidney Oxygenation in Participants with or without T2D BOLD MRI (blood oxygenation-level dependent magnetic resonance imaging). [Time Frame: Baseline, Week 52]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Tirzepatide

PRD11922455 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922454 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922456 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922453 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922458 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922457 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS
Max daily dose
00 Other
Max total dose
00 Other
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

Placebo to match LY3298176

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

Iohexol

SCP1841905 · ATC

Active substance
Iohexol
Route of administration
SOLUTION FOR INJECTION
Max daily dose
647 mg/ml milligram(s)/millilitre
Max total dose
1294 mg/ml milligram(s)/millilitre
Max treatment duration
2 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.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 12

OrganisationCity, countryDuties
Quintiles Laboratories Europe
ORG-100017355
 Livingston, United Kingdom Laboratory analysis
IQVIA RDS (India) Private Limited
ORG-100047036
 Mumbai, India Laboratory analysis
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Clinical Trial Media Inc.
ORG-100046339
 Hauppauge, United States Code 2
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring
Q Squared Solutions Holdings LLC
ORG-100043288
 Valencia, United States Laboratory analysis
Bioclinica Inc.
ORG-100033079
 Princeton, United States Laboratory analysis

Locations

3 EU/EEA countries · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 12 3
Denmark Ended 12 1
Netherlands Ended 20 2
Rest of world
United States, Canada, Mexico
 — 96 —

Investigational sites

Austria

3 sites · Ongoing, recruitment ended
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstrasse 1, Hietzing, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Centre for Clinical Studies Dr. Hanusch GmbH, Gumpendorfer Strasse 95/9, Mariahilf, Vienna
Klinik Landstrabe
1st Medical Department, Juchgasse 25, Landstrasse, Vienna

Denmark

1 site · Ended
Region Midtjylland
Steno Diabetes Center - Aarhaus, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Netherlands

2 sites · Ended
VUmc Stichting
Clinical Endocrinology and Internal medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Ziekenhuisgroep Twente Stichting
Internal Medicine, Zilvermeeuw 1, 7609 PP, Almelo

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-09-01 2023-09-15 2025-07-08
Denmark 2023-02-28 2026-03-09 2023-03-17 2025-07-08
Netherlands 2023-05-30 2026-05-07 2023-07-06 2025-07-08

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.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-506082-60-00_Redacted d
Protocol (for publication) D4_Patient facing document Copyright Statement 1
Recruitment arrangements (for publication) K2_AT_Recruitment Poster_GEA 1
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_DK 2.0
Recruitment arrangements (for publication) K2_AT_Appointment Reminder Card_GEA 1
Recruitment arrangements (for publication) K2_AT_Digital Ads_GEA 1
Recruitment arrangements (for publication) K2_AT_Dr to Patient Letter_GEA_Redacted 1
Recruitment arrangements (for publication) K2_AT_Emergency Card_GEA 1
Recruitment arrangements (for publication) K2_AT_Participant Study Guide_GEA 1
Recruitment arrangements (for publication) K2_AT_Print Ad_GEA 1
Recruitment arrangements (for publication) K2_AT_Recruitment Brochure_GEA_Redacted 1
Recruitment arrangements (for publication) K2_AT_Recruitment Flyer_GEA 1
Recruitment arrangements (for publication) K2_AT_Search Ad_GEA 1
Recruitment arrangements (for publication) K2_AT_Thank You Card_GEA 1
Recruitment arrangements (for publication) K2_AT_Website Copy_GEA_Redacted 1
Recruitment arrangements (for publication) K2_AT_WS Prescreener_GEA_Redacted 2
Recruitment arrangements (for publication) K2_CTM_ELI LILLY_GPIG_WS Prescreener_DAN 1.0
Recruitment arrangements (for publication) K2_Protocol Supplement 1.0
Recruitment arrangements (for publication) K2_Recruitment material Digital Ads 1.0
Recruitment arrangements (for publication) K2_Recruitment material Dr to Patient Email_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material Dr to Patient Letter_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material Pre-screening Questions_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material Print Ad 1
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Brochure_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Flyer 1.1
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Poster 1.1
Recruitment arrangements (for publication) K2_Recruitment material Search Ad 1
Recruitment arrangements (for publication) K2_Recruitment material Website Copy_Redacted 1.1
Subject information and informed consent form (for publication) Dine rettigheder som forsgsperson i forsg med medicin 1.0
Subject information and informed consent form (for publication) I8F-MC-GPIG ICF Denmark_V6_18Jul2024dan_clean_Redacted 6.0
Subject information and informed consent form (for publication) I8F-MC-GPIG ICF Denmark_V6_18Jul2024dan_TC 6.0
Subject information and informed consent form (for publication) L1_AT_Travel Cost Reimbursement Form_Redacted 2
Subject information and informed consent form (for publication) L1_Main ICF_Austria_Redacted 6.0
Subject information and informed consent form (for publication) L1_Reimbursement ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and Main ICF_Redacted 6.0
Subject information and informed consent form (for publication) L2_List of ssICF contact details_Redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material Confidentiality Notice Netherlands 3
Subject information and informed consent form (for publication) L3_Patient Card_German_Ludvik 1
Subject information and informed consent form (for publication) L3_Patient Card_Hanusch 1
Subject information and informed consent form (for publication) L3_Patient Card_Stulnig 1
Synopsis of the protocol (for publication) D1_AT_Protocol Synopsis_Redacted b
Synopsis of the protocol (for publication) D1_Protocol synopsis_ATDE_2023-506082-60-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_DK_2023-506082-60-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL_2023-506082-60-00_Redacted d

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-10-26 Austria Acceptable
2024-01-02
 2024-01-02
2 SUBSTANTIAL MODIFICATION SM-1 2024-02-15 Austria Acceptable
2024-05-28
 2024-05-29
3 SUBSTANTIAL MODIFICATION SM-3 2024-06-07 Acceptable 2024-07-15
4 SUBSTANTIAL MODIFICATION SM-4 2024-07-23 Austria Acceptable
2024-09-23
 2024-09-25
5 NON SUBSTANTIAL MODIFICATION NSM-1 2025-07-03 Austria Acceptable
2024-09-23
 2025-07-03
6 NON SUBSTANTIAL MODIFICATION NSM-2 2025-07-16 Acceptable
2024-09-23
 2025-07-16
7 SUBSTANTIAL MODIFICATION SM-6 2025-08-20 Austria Acceptable
2025-10-20
 2025-10-21

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