Tirzepatide for Obesity and Chronic Kidney Disease

(TREASURE-CKD Trial)

Not currently recruiting at 47 trial locations

Overseen By Eric Hewitt

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: ACE inhibitors, ARBs

Must not be taking: GI motility drugs

Disqualifiers: Obesity surgery, Pancreatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 52 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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

My HbA1c level is 9.5% or lower.

I have been diagnosed with chronic kidney disease.

My kidney function is within the required range for the study.

Exclusion Criteria

My kidneys are stable and not getting worse quickly.

I haven't had, nor plan to have, any device-based obesity treatments.

All participants must not have a self-reported change in body weight >5 kg within 90 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or placebo administered subcutaneously

52 weeks

Up to 12 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tirzepatide

Trial Overview The study tests Tirzepatide's effectiveness against CKD in obese individuals over approximately one year through up to 12 visits. Participants will either receive Tirzepatide or a placebo to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

Tirzepatide administered subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Placebo administered SC

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

• Type 2 diabetes

Approved in European Union as Mounjaro for:

• Type 2 diabetes

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Approved in United States as Zepbound for:

• Weight loss
• Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

• Weight loss

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

Published Research Related to This Trial

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide, a once-weekly GIP/GLP-1 receptor agonist, is being evaluated in a large cardiovascular outcomes trial involving 13,299 participants with type 2 diabetes and established cardiovascular disease to assess its safety and efficacy compared to dulaglutide.

The primary goal of the trial is to determine if tirzepatide is noninferior to dulaglutide in preventing major adverse cardiovascular events (MACE), which will help establish its cardiovascular benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Nicholls, SJ., Bhatt, DL., Buse, JB., et al.[2023]

Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).

Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. Mishra, R., Raj, R., Elshimy, G., et al.[2023]

Tirzepatide is a dual GIP/GLP-1 receptor agonist that can be administered once a week, showing significant improvements in glycemic control, insulin sensitivity, and body weight in patients with type 2 diabetes mellitus (T2DM) based on phase 1, 2, and 3 clinical trials.

The drug not only helps lower blood sugar levels but also positively affects lipid metabolism, making it a promising treatment option for T2DM and related cardiometabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide - a dual GIP/GLP-1 receptor agonist - a new antidiabetic drug with potential metabolic activity in the treatment of type 2 diabetes. Nowak, M., Nowak, W., Grzeszczak, W.[2022]

In the SURPASS-4 trial, tirzepatide significantly slowed the decline of kidney function (eGFR) compared to insulin glargine, with a difference of 2.2 mL/min per year, indicating better kidney protection for people with type 2 diabetes.

Tirzepatide also reduced the urine albumin-creatinine ratio (UACR) by 6.8%, while UACR increased by 36.9% in the insulin group, suggesting that tirzepatide may offer additional renal benefits in patients at high cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial. Heerspink, HJL., Sattar, N., Pavo, I., et al.[2022]

Tirzepatide, a novel GIP/GLP-1 receptor agonist, has shown significant reductions in HbA1c levels and clinically meaningful weight loss in type 2 diabetes patients, with low rates of hypoglycemia, based on results from the SURPASS clinical trial program.

The safety profile of tirzepatide is comparable to existing GLP-1 receptor agonists, and while dedicated cardiovascular and kidney trial results are pending, early indications suggest potential benefits in these areas for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging Clinical Perspectives in Type 2 Diabetes with Tirzepatide, a First-in-Class Twincretin. MacIsaac, RJ., Deed, G., D'Emden, M., et al.[2023]

Tirzepatide, a newly approved medication for type 2 diabetes, not only improves glycemic control but also significantly reduces body weight and various cardiovascular risk factors in individuals with obesity or overweight.

In a clinical trial, tirzepatide demonstrated protective effects on kidney health, reducing the risk of serious kidney-related outcomes by nearly half compared to insulin glargine, while also causing an initial decrease in kidney function that is common with kidney-protective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide and prevention of chronic kidney disease. Bosch, C., Carriazo, S., Soler, MJ., et al.[2023]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.

The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05536804

NCT05536804 | A Study of Tirzepatide (LY3298176) in ... 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 ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822209

Clinical Outcomes of Tirzepatide or GLP-1 Receptor ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11581768/

GLP-1 receptor agonists in patients with chronic kidney ... This review addresses the promising landscape of GLP-1 RAs to treat persons with overweight or obesity, with or without T2DM, within the context of CKD.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590059525000494

Utilization Trends of Dual GIP/GLP-1 Receptor Agonist ... Among 455,047 patients with CKD and T2D, tirzepatide any users increased to 4.8% in September 2023, while incident users rose from 0.8% to 8.6%.

6. investor.lilly.com investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist ... Results from the largest and longest Mounjaro trial to date reaffirm its established safety and tolerability profile. INDIANAPOLIS , July 31 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320168/

Clinical Outcomes of Tirzepatide or GLP-1 Receptor Agonists ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...