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Prediabetes
Type 2

New Trial Studying Tirzepatide for Chronic Kidney Disease

4 Minute Read
Zepbound

Eli Lilly's weight-loss drug, Zepbound (tirzepatide).

If you are an adult living with kidney disease and excess weight or obesity, you may be eligible to join a trial studying the impact of tirzepatide on kidney function.

Clinical Trials Identifier: NCT05536804

Trial Name: 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 (TREASURE-CKD)

Diabetes Type: With or without type 2 diabetes

Trial Sponsor: Eli Lilly and Company

What is the aim of the study? 

This study is investigating whether the dual GIP/GLP-1 agonist tirzepatide (sold as Mounjaro for type 2 diabetes and Zepbound for obesity) can help fight chronic kidney disease in people with obesity with or without type 2 diabetes.

Therapies such as tirzepatide belong to a medication class known as incretins. Some drugs in this class, like semaglutide (sold as Ozempic for type 2 diabetes and Wegovy for weight loss), have recently become FDA-approved for uses beyond type 2 diabetes management, including weight management and reduction of cardiovascular events.

Recent research has also shown that semaglutide can significantly prevent kidney disease progression and cut the risk of death from kidney disease; the FDA is currently reviewing a requested label expansion to reflect this new use.

Similarly, conducting research like this to evaluate whether tirzepatide can help slow kidney disease could potentially lead to a label expansion from the FDA for chronic kidney disease as well.

How does the trial work?

For this trial, researchers are recruiting roughly 140 adults with or without type 2 diabetes who also have a body mass index (BMI) of 27 or above and have chronic kidney disease. 

Participants will receive either tirzepatide or a placebo (the active comparator or control). All participants will receive multiple methods of magnetic resonance imaging (MRI). 

Participants will also be tested for body weight, estimated glomerular filtration rate (eGFR), urine albumin-to-creatinine ratio (UACR), and 24-hour urinary albumin excretion (UAE), both at the time of screening and at week 52 near the conclusion of the study. In total, the study will last about 13 months and include up to 12 visits. 

Why is this study important?

If study data indicates that tirzepatide can significantly slow the progression of kidney disease and reduce the risk of death from kidney disease, then tirzepatide could potentially receive FDA approval for chronic kidney disease. It would join other SGLT-2 inhibitors and GLP-1 medications as another viable treatment for kidney disease.

Are you interested in participating? 

You may be eligible if you: 

  • Are aged 18 or older, either with or without type 2 diabetes, with a BMI of 27 or greater
  • Have been diagnosed with chronic kidney disease
  • Either have an eGFR between 25-60, or an eGFR between 25-75 with a UACR of more than 30
  • Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximum appropriate dose for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)
  • Have an A1C of below 6.5 (if you do not have type 2 diabetes)
  • Have an A1C of below 9.5 (if you do have type 2 diabetes), as well as a diabetes diagnosis that occurred more than 180 days prior to screening

People who have lost or gained more than 11 pounds (5 kg) within 90 days of screening, people with type 1 diabetes, and people who have had or plan to have bariatric surgery or device-based therapy for obesity may not be eligible to participate. 

Other exclusions include an eGFR of more than 25, a history of unstable or rapidly progressing kidney disease, severe gastroparesis or other gastric emptying conditions, pancreatitis, diabetic macular edema, and certain types of diabetic retinopathy. See a full list of inclusion and exclusion criteria here.

This study is recruiting in California, Colorado, Indiana, Michigan, and Washington, as well as Austria, Canada, Denmark, Mexico, and the Netherlands. To enroll or learn more, contact the Eli Lilly and Company clinical trials team at [email protected] or call 1-877-CTLILLY (1-877-285-4559) or (317) 615-4559.

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Photo credit: Eli Lilly and Company