What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) similar to Tirzepatide, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), often cause gastrointestinal side effects like nausea and vomiting. They are also linked to an increased risk of pancreatitis and potential pancreatic cancer, with concerns about long-term pancreatic effects, including glucagon-producing neuroendocrine tumors. Tolvaptan, another CKD treatment, can slow kidney function decline but may cause liver toxicity. TRF-budesonide can lead to glucocorticoid-related adverse events, including Cushingoid features.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes, which have shown benefits in weight loss and glycemic control, indirectly benefiting patients with Chronic Kidney Disease (CKD). Notable drugs in this category include Liraglutide and Semaglutide. These drugs have demonstrated cardiovascular benefits and are used in patients with or without diabetes. While specific FDA approvals for CKD treatment using dual GIP and GLP-1 receptor agonists like Tirzepatide are still under investigation, the existing GLP-1 receptor agonists provide a promising foundation for future therapies targeting CKD.

What other types of research exist?

Promising alternatives to Tirzepatide for CKD patients include: 1) Liraglutide, a GLP-1 receptor agonist, which has shown cardiovascular and kidney benefits in the LEADER trial. 2) TRF-budesonide, which has demonstrated a reduction in urine protein-to-creatinine ratio and stable eGFR in patients with IgA nephropathy. 3) Dipeptidyl Peptidase-4 (DPP-4) inhibitors, which have shown renoprotective effects in patients with type 2 diabetes. These alternatives should be discussed with a healthcare provider to determine the best treatment option based on individual patient needs and conditions.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Tirzepatide for Obesity and Chronic Kidney Disease (TREASURE-CKD Trial)

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 52

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of drugs like Tirzepatide may include digestive issues such as nausea or diarrhea; potential risks could also involve low blood sugar levels especially in those with type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kidney

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Tirzepatide administered subcutaneously (SC)

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered SC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) include GLP-1 receptor agonists and SGLT2 inhibitors. GLP-1 receptor agonists, such as those similar to Tirzepatide, work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which helps in controlling blood glucose levels and reducing weight. This is crucial for CKD patients as it can slow the progression of kidney damage and reduce cardiovascular risks. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to lower blood glucose levels and reduced blood pressure, which also helps in mitigating kidney damage and improving cardiovascular outcomes. These mechanisms are vital for managing CKD as they address both glycemic control and the associated cardiovascular risks, which are common complications in CKD patients.

Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Timing of Dialysis Initiation: What Has Changed Since IDEAL?HMG CoA reductase inhibitors (statins) for dialysis patients.