Tirzepatide for Obesity and Chronic Kidney Disease
(TREASURE-CKD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the drug tirzepatide (also known as Mounjaro, Zepbound, or LY3298176) can benefit individuals with obesity and chronic kidney disease. Researchers aim to determine if tirzepatide can improve kidney health, regardless of type 2 diabetes status. Participants will receive either tirzepatide or a placebo (a substance with no active medicine) for comparison. Suitable candidates have a BMI of 27 or more and a diagnosis of chronic kidney disease. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of ACE or ARB medications for chronic kidney disease or hypertension unless you have low blood pressure.
Is there any evidence suggesting that tirzepatide is likely to be safe for humans?
Studies have shown that tirzepatide is generally safe and well-tolerated. Research indicates that it may lower the risk of major heart and kidney problems. In previous studies, people taking tirzepatide experienced fewer serious health issues compared to those not taking it. Another study found that tirzepatide maintained a consistent safety record, with no unexpected side effects. Most side effects were mild, such as nausea or diarrhea, and often improved over time. Overall, the evidence suggests that tirzepatide is safe for use.12345
Why do researchers think this study treatment might be promising for chronic kidney disease?
Researchers are excited about tirzepatide because it offers a new approach to managing obesity and chronic kidney disease. Unlike most treatments that focus solely on reducing appetite or inhibiting fat absorption, tirzepatide is a dual-action drug that mimics the effects of two hormones, GLP-1 and GIP, which are involved in blood sugar regulation and appetite control. This novel mechanism not only aids in weight loss but also holds promise for improving kidney function. Additionally, tirzepatide is administered via a simple subcutaneous injection, making it a convenient option for patients.
What evidence suggests that tirzepatide might be an effective treatment for chronic kidney disease in people with obesity?
Research shows that tirzepatide, which participants in this trial may receive, can greatly reduce serious kidney and heart problems in people with obesity, especially those with type 2 diabetes. Studies have found that tirzepatide lowers the risk of death from any cause and reduces serious kidney issues. It also helps people with obesity lose weight and maintain that weight loss over time. These findings suggest that tirzepatide could be a promising option for managing chronic kidney disease in people with obesity.12567
Who Is on the Research Team?
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)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with obesity and chronic kidney disease (CKD), with or without type 2 diabetes. They should have a BMI ≥27 kg/m², stable CKD, and be on certain blood pressure medications unless they have low blood pressure. People can't join if they've had recent weight changes over 5kg, gastric issues affecting digestion, unstable kidney disease, specific eye conditions related to diabetes, pancreatitis history, or any surgical treatment for obesity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tirzepatide or placebo administered subcutaneously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Tirzepatide
Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:
- Type 2 diabetes
- Type 2 diabetes
- Type 2 diabetes
- Weight loss
- Moderate to severe obstructive sleep apnea
- Weight loss
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University