A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
This research study is exploring a new medication known as tirzepatide. We want to understand if this medicine can help people who have chronic kidney disease, especially if they are also overweight or living with obesity. This includes individuals who may or may not have type 2 diabetes. The main goal is to see if tirzepatide can improve or prevent kidney issues in these groups. The study will last for about 56 weeks, which is just over a year, and involves up to 12 visits to the study clinic during this time. This is a common type of study where some people will receive the new medicine and others will receive a placebo, which is an inactive treatment, to compare the effects.
At a glance
What is this study about?
This study is investigating a new medicine called tirzepatide. We're trying to find out if it can help people who have ongoing kidney problems, known as chronic kidney disease. This is particularly important for individuals who are also overweight, living with obesity, and may or may not have type 2 diabetes. Kidney disease can be a serious condition, and finding new ways to manage it, especially in people with these related health issues, is very important.
At the moment, we believe tirzepatide might help because it has shown promise in managing weight and blood sugar, which can both impact kidney health. By taking part in this study, you could help us learn more about how this medicine works, and potentially contribute to developing new treatments for many people in the future. We're carefully comparing tirzepatide to a placebo (a dummy treatment) to understand its effects properly.
Your involvement is crucial. Studies like this help doctors and researchers understand if new medicines are safe and effective. All information gathered is used strictly for research purposes, and your privacy is always protected. This is a scientific process designed to improve health outcomes for people in the longer term.
Key takeaways
- The study investigates a new medicine, tirzepatide, for chronic kidney disease.
- It focuses on people who are overweight or have obesity, with or without type 2 diabetes.
- Participation involves up to 12 clinic visits over approximately 56 weeks.
- You might receive the active medicine or a placebo.
- Your safety and well-being are closely monitored throughout the study.
- Your involvement could help improve future treatments for kidney disease.
Who may be eligible?
To join this study, you need to be aged 18 or older. You must be overweight or living with obesity (meaning your BMI is 27 or higher) and have chronic kidney disease. This kidney condition means your kidneys aren't working as well as they should, with specific measures of kidney function falling within a certain range. You also need to be taking an ACE or ARB medication for your kidney or blood pressure problems, unless your doctor says your blood pressure is too low for this.
If you have type 2 diabetes, you must have been diagnosed at least six months ago and your blood sugar control needs to be within a certain range. If you don't have diabetes, your blood sugar levels must be below a specific point. We can't include you if your weight has changed a lot recently (more than 5 kg in the last 3 months), or if you've had or plan to have surgery or other treatments for obesity. People with severe stomach problems, active kidney disease that is getting worse quickly, or a history of pancreatitis are also unable to join. If you have type 2 diabetes, certain serious eye conditions related to diabetes would also prevent you from participating.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you overweight or living with obesity (BMI of 27 or higher)?
- Do you have chronic kidney disease?
- Are you currently taking ACE or ARB medication for your kidney or blood pressure (unless deemed unsuitable by your doctor)?
- Have you *not* had any major weight change (over 5kg) in the last 3 months?
- Have you *not* had or planned for obesity surgery or other obesity treatments (like gastric balloons)?
What does participation involve?
If you decide to take part, the study will last for about 56 weeks, which is just over a year. During this time, you'll need to attend up to 12 visits at the study clinic. These visits will involve various health checks, such as blood tests, urine tests, and monitoring your overall health. You will be given either the study medicine, tirzepatide, or a placebo (an inactive treatment) to take regularly, as instructed by the study team. Both you and the study team may not know whether you are receiving the active drug or the placebo until the end of the study. This helps ensure fair results. The study team will provide all necessary medication and support throughout your participation. You have the right to withdraw from the study at any time.
Potential risks and benefits
Locations (27)
- Valley Clinical Trials, Inc.Verified postcodeNorthridge, United States
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States
- Kidney Associates of ColoradoVerified postcodeDenver, United States
- American Health Network of Indiana, LLC - AvonVerified postcodeAvon, United States
- American Health Network of Indiana, LLC - GreenfieldVerified postcodeGreenfield, United States
- Indiana University Health University HospitalVerified postcodeIndianapolis, United States
- American Health Network of Indiana, LLC - MuncieVerified postcodeMuncie, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionVerified postcodeTroy, United States
- University of Washington Medical Center - MontlakeVerified postcodeSeattle, United States
- Providence Medical Research Center - SpokaneVerified postcodeSpokane, United States
- Klinik LandstraßeVerified postcodeVienna, Austria
- Zentrum für klinische Studien Dr Hanusch GmbhVerified postcodeVienna, Austria
Common questions
What is tirzepatide?
Tirzepatide is a new medicine being studied to see if it can help people with kidney disease, especially if they are also overweight or have type 2 diabetes.
What is a placebo?
A placebo is an inactive treatment that looks like the study medicine but contains no active drug. It helps researchers compare the effects of the real medicine.
How long will the study last?
The study will last for about 56 weeks, which is a little over a year, with up to 12 clinic visits during this period.
Is my privacy protected?
Yes, all information gathered during the study is used only for research and your personal details are kept private and confidential.
Can I leave the study if I change my mind?
Absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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