ACTIVE_NOT_RECRUITING

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

Conditions

Overweight Obesity Chronic Kidney Disease Type 2 Diabetes T2D

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.

Official Title

Tirzepatide Study of Renal Function in People With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease Using Multiparametric Magnetic Resonance Imaging

Quick Facts

Study Start:2023-02-08

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05536804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening * Diagnosed with chronic kidney disease (CKD) * Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \>30 milligram/gram (mg/g) * Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension) * Have Hemoglobin A1c (HbA1c) \<6.5% at screening * Have been diagnosed at least 180 days prior to screening * Have HbA1c ≤9.5% at screening	* Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening. * Have a prior or planned surgical treatment for obesity * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days * Have eGFR \<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening. * Have a history of unstable or rapidly progressing renal disease according to investigator judgment * Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility) * Have had a history of chronic or acute pancreatitis * Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment. * Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

Inclusion Criteria

Exclusion Criteria

* Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
* Diagnosed with chronic kidney disease (CKD)
* Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \>30 milligram/gram (mg/g)
* Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)
* Have Hemoglobin A1c (HbA1c) \<6.5% at screening
* Have been diagnosed at least 180 days prior to screening
* Have HbA1c ≤9.5% at screening

* Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days
* Have eGFR \<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.
* Have a history of unstable or rapidly progressing renal disease according to investigator judgment
* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)
* Have had a history of chronic or acute pancreatitis
* Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.
* Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Valley Clinical Trials, Inc.

Northridge, California, 91325

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Kidney Associates of Colorado

Denver, Colorado, 80210

United States

American Health Network of Indiana, LLC - Avon

Avon, Indiana, 46123

United States

American Health Network of Indiana, LLC - Greenfield

Greenfield, Indiana, 46140

United States

Indiana University Health University Hospital

Indianapolis, Indiana, 46202

United States

American Health Network of Indiana, LLC - Muncie

Muncie, Indiana, 47304

United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

Providence Medical Research Center - Spokane

Spokane, Washington, 99204

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-08

Study Completion Date2026-10

Study Record Updates

Study Start Date2023-02-08

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Overweight
Obesity
Chronic Kidney Disease
Type 2 Diabetes
T2D