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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
TREASURE-CKD Trial 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.
TREASURE-CKD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52
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 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
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
TREASURE-CKD 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
~7590
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,616 Previous Clinical Trials
3,201,030 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,345 Previous Clinical Trials
405,224 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My HbA1c level is 9.5% or lower.My kidneys are stable and not getting worse quickly.I haven't had, nor plan to have, any device-based obesity treatments.I have been diagnosed with chronic kidney disease.My kidney function is within the required range for the study.I have been diagnosed with chronic kidney disease.Your HbA1c level is between 7.0% and 10.5% at screening.I have not had, nor am I planning to have, surgery for weight loss.I have never had chronic or acute pancreatitis.My kidney function is not severely reduced.My BMI is 27 or higher.I was diagnosed with Type 2 diabetes more than 6 months ago.I have type 2 diabetes but no serious eye problems from it.I don't have stomach emptying issues or take drugs for GI movement.I have type 2 diabetes and have never been diagnosed with type 1 diabetes or had ketoacidosis.I am taking the highest dose possible of ACE inhibitors or ARBs for my kidney disease or high blood pressure, unless I have low blood pressure.Your body mass index (BMI) is 27 or higher.I am on the highest dose of ACE inhibitors or ARBs for my kidney disease or high blood pressure, unless I have low blood pressure.My kidney function is moderately reduced but not severe.Your Hemoglobin A1c level is less than 6.5% at the initial check-up.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What detrimental effects may Tirzepatide have on its users?
"Tirzepatide is currently assessed as a Level 2, given that safety data has been collected but efficacy results have yet to be seen."
Answered by AI
Is enrollment open for this medical experiment at the moment?
"As per the details on clinicaltrials.gov, this medical study is not currently accepting new participants, having been initially posted on November 29th 2022 and last modified on November 18th 2022. However, there are nearly three thousand other trials actively seeking patients at present."
Answered by AI
Are any medical facilities in North America involved with this clinical research?
"Participating in this trial can take place at 14 distinct medical facilities which include, but are not limited to LMC Clinical Research Inc. (Thornhill) in Concord, Kidney Associates of Colorado in Denver, and Arcturus Healthcare , PLC, Troy Internal Medicine Research Division in Troy."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What state do they live in?
California
Michigan
Washington
What site did they apply to?
Valley Clinical Trials, Inc.
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
University of Washington Medical Center
Why did patients apply to this trial?
I have tried for years to lose weight. It's been a hard process and will be thankful for any help I can get in accomplishing my goals. When I do lose a little weight, I gain it all back plus a few extra pounds each time. I have gained over 40 pounds. Help! Thank you so much. 🙏🏻😇.
PatientReceived 2+ prior treatments
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