Tirzepatide for Obesity and Chronic Kidney Disease

(TREASURE-CKD Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing tirzepatide to see if it can help people with obesity, with or without type 2 diabetes, who have chronic kidney disease. The medication works by controlling blood sugar and reducing weight, which may improve kidney function. Tirzepatide is a new medication given regularly, effective in treating obesity in patients with and without diabetes.

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.

What data supports the effectiveness of the drug tirzepatide for obesity and chronic kidney disease?

Tirzepatide has been shown to significantly reduce body weight and improve kidney health markers in people with type 2 diabetes, which suggests it may be effective for obesity and chronic kidney disease. In clinical trials, it decreased body weight, blood pressure, and improved kidney function compared to other treatments. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been tested in people with type 2 diabetes and has shown similar safety to other treatments in its class, with common side effects like nausea, vomiting, diarrhea, and constipation, especially at higher doses. It may also have benefits for heart and kidney health, but more research is needed to confirm these effects. ^{1 2 6 7 8}

How is the drug Tirzepatide unique for treating obesity and chronic kidney disease?

Tirzepatide is unique because it is a 'twincretin' that targets both GIP and GLP-1 receptors, which helps reduce body weight and improve metabolic health. It is administered once a week and has shown potential benefits for kidney health, making it different from other treatments that typically focus on just one of these aspects. ^{1 2 3 9 10}

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

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Placebo (Drug)
• Tirzepatide (Glucagon-like peptide-1 (GLP-1) receptor agonist)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Mounjaro for:

• Type 2 diabetes

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

Findings from Research

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, 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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tirzepatide and prevention of chronic kidney disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Challenging Clinical Perspectives in Type 2 Diabetes with Tirzepatide, a First-in-Class Twincretin. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. [2023]

4. England 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. [2022]

5. England 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. [2023]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. [2023]

9. United States 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. [2023]

10. Poland 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. [2022]