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

Launched by ELI LILLY AND COMPANY · Sep 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirzepatide to see how it can help people with overweight or obesity who also have chronic kidney disease (CKD), whether or not they have type 2 diabetes (T2D). The goal is to learn more about how this medication might improve kidney health in these individuals. The study will last for about 56 weeks, during which participants will come in for up to 12 visits.

To be eligible for the trial, participants should be between 65 and 74 years old and have a Body Mass Index (BMI) of 27 or higher, indicating they are overweight. They must also have been diagnosed with chronic kidney disease and meet specific kidney function requirements. Participants with T2D need to have been diagnosed for at least six months and have specific blood sugar levels. Throughout the study, participants will be monitored closely, and all treatments will be provided under careful supervision to ensure safety. This trial is a great opportunity for those looking to contribute to research aimed at improving health outcomes for people with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All participants with or without diabetes:
• • 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)
• Participants without diabetes:
• • Have Hemoglobin A1c (HbA1c) \<6.5% at screening
• Participants with Type 2 diabetes:
• • Have been diagnosed at least 180 days prior to screening
• • Have HbA1c ≤9.5% at screening
• Exclusion Criteria:
• All participants:
• • 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
• Participants with T2D:
• • 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