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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
Awards & highlights

Summary

This trial is testing a new drug to see if it can help fight chronic kidney disease in obese people, with or 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kidney
Secondary outcome measures
Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)
Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI
Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)
+7 more

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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

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
~5560

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.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,970 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
416,336 Total Patients Enrolled

Media Library

Tirzepatide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05536804 — Phase 2
Chronic Kidney Disease Research Study Groups: Tirzepatide, Placebo
Chronic Kidney Disease Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05536804 — Phase 2
Tirzepatide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536804 — Phase 2
~72 spots leftby Jan 2026