Clinical trial • Phase II • Endocrinology|Nephrology
TIRZEPATIDE for Chronic kidney disease|Obesity|Overweight|Type 2 diabetes
Phase II trial of TIRZEPATIDE for Chronic kidney disease|Obesity|Overweight|Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology|Nephrology
- Trial Disease
- Chronic kidney disease|Obesity|Overweight|Type 2 diabetes
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme|Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 26-10-2023
- First CTIS Authorization Date
- 02-01-2024
Trial design
Randomised, tirzepatide mtd qw (investigational arm) versus placebo to match ly3298176 (placebo arm); tirzepatide administered qw (once weekly) as stated in the main objective. no numeric doses given in provided data.-controlled Phase II trial across 6 sites in Denmark, Austria, Netherlands.
- Randomised
- Yes
- Comparator
- Tirzepatide MTD QW (investigational arm) versus Placebo to match LY3298176 (placebo arm); tirzepatide administered QW (once weekly) as stated in the main objective. No numeric doses given in provided data.
- Target Sample Size
- 96
- Trial Duration For Participant
- 364
Stratification factors
- Type 2 diabetes status (with vs without T2D)
Eligibility
Recruits 96 Vulnerable population flag selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the documents for participating countries (Denmark, Austria, Netherlands). No specific details on assent or age‑specific consent procedures are provided in the available data..
- Vulnerable Population
- Vulnerable population flag selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the documents for participating countries (Denmark, Austria, Netherlands). No specific details on assent or age‑specific consent procedures are provided in the available data.
Inclusion criteria
- {"criterion_text":"- Have obesity or overweight"}
- {"criterion_text":"- Have chronic kidney disease"}
- {"criterion_text":"- Half of participants must have type 2 diabetes and half of participants must not have type 2 diabetes"}
Exclusion criteria
- {"criterion_text":"- Have a history of diabetic eye diseases"}
- {"criterion_text":"- Have gained weight within 90 days before study"}
- {"criterion_text":"- Have a history of unstable or severe kidney disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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]","definition_or_measurement_approach":"Measured by BOLD MRI (blood oxygenation-level dependent magnetic resonance imaging) comparing change from baseline to Week 52."}
Recruitment
- Digital Remote Recruitment
- True, using digital ads, search ads, website copy and online recruitment materials as listed in recruitment documents (country-specific digital materials referenced)
- Planned Sample Size
- 96
- Recruitment Window Months
- 45
- Consent Approach
- Subject information and informed consent forms are provided and listed by country (e.g. 'I8F-MC-GPIG ICF Denmark_V6_18Jul2024dan_clean_Redacted' for Denmark; 'L1_Main ICF_Austria_Redacted' for Austria; 'L1_SIS and Main ICF_Redacted' for Netherlands). Contact for trial information: EU_lilly_clinical_trials@lilly.com. No further details on who provides consent (e.g. legal guardian) or on assent procedures are provided in the available data.
Methods
- Digital Ads (titles in documents: K2_AT_Digital Ads_GEA, K2_Recruitment material Digital Ads) targeting potential participants
- Website copy / online recruitment (K2_AT_Website Copy_GEA, K2_Recruitment material Website Copy_Redacted)
- Search ads / Print ads (K2_AT_Search Ad_GEA, K2_AT_Print Ad_GEA, K2_Recruitment material Print Ad)
- Recruitment flyers, brochures, posters (K2_AT_Recruitment Flyer_GEA, K2_AT_Recruitment Flyer_GEA, K2_Recruitment material Recruitment Flyer, K2_Recruitment material Recruitment Poster)
- Doctor-to-patient letters and emails (K2_AT_Dr to Patient Letter_GEA_Redacted, K2_Recruitment material Dr to Patient Email_Redacted, K2_Recruitment material Dr to Patient Letter_Redacted)
- Prescreener / prescreening questions and site prescreener materials (K2_CTM_ELI LILLY_GPIG_WS Prescreener_DAN, K2_AT_WS Prescreener_GEA, K2_Recruitment material Pre-screening Questions_Redacted)
- Appointment reminder cards, thank you cards and patient study guides (K2_AT_Appointment Reminder Card_GEA, K2_AT_Thank You Card_GEA, K2_AT_Participant Study Guide_GEA)
- Country-specific printed and electronic recruitment materials (documents labelled K1_... for Denmark, K2_AT_... for Austria, K2_.../K1_... for Netherlands)
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 44
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-11-2023
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 708
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Region Midtjylland
- Department Name
- Steno Diabetes Center - Aarhaus
- Contact Person Name
- Soren Tang Knudsen
- Contact Person Email
- soerknud@rm.dk
Austria
- Earliest CTIS Part Ii Submission Date
- 13-11-2023
- Latest Decision Or Authorization Date
- 22-10-2025
- Processing Time Days
- 709
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Klinik Landstrabe
- Department Name
- 1st Medical Department
- Contact Person Name
- Bernhard Ludvik
- Contact Person Email
- bernhard.ludvik@gesundheitsverbund.at
- Site Name
- Klinik Hietzing
- Department Name
- Karl Landsteiner Institute for Metabolic Disease and Nephrology
- Contact Person Name
- Thomas Stulnig
- Contact Person Email
- thomas.stulnig@meduniwien.ac.at
- Site Name
- Zentrum Fur Klinische Studien Dr. Hanusch GmbH
- Department Name
- Centre for Clinical Studies Dr. Hanusch GmbH
- Contact Person Name
- Ursula Hanusch
- Contact Person Email
- dr.hanusch@dieinternistin.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-11-2023
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 708
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Ziekenhuisgroep Twente Stichting
- Department Name
- Internal Medicine
- Contact Person Name
- Goos Laverman
- Contact Person Email
- g.laverman@zgt.nl
- Site Name
- VUmc Stichting
- Department Name
- Clinical Endocrinology and Internal medicine
- Contact Person Name
- Daniel Van Raalte
- Contact Person Email
- d.vanraalte@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Quintiles Laboratories Europe
- Responsibilities
- code 4
- Name
- IQVIA RDS (India) Private Limited
- Responsibilities
- code 4
- Name
- Q2 Solutions LLC
- Responsibilities
- code 4
- Name
- Q Squared Solutions Holdings LLC
- Responsibilities
- code 4
- Name
- Bioclinica Inc.
- Responsibilities
- code 4
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- code 4
- Name
- Iqvia Rds Inc.
- Responsibilities
- code 1
Third parties
- {"country":"United Kingdom","full_name":"Quintiles Laboratories Europe","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"IQVIA RDS (India) Private Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- TIRZEPATIDE
- Active Substance
- TIRZEPATIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once weekly (QW) as stated in objective
- Investigational Product Name
- Placebo to match LY3298176
- Modality
- Other
- Investigational Product Name
- IOHEXOL
- Active Substance
- IOHEXOL
- Modality
- Diagnostic agent
- Routes Of Administration
- Solution for injection
- Route
- Injection (contrast agent)
- Authorisation Status
- Authorised (SCP1841905)
- Maximum Dose
- 1294 mg/ml (max total amount as listed)
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