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GLP-1 Receptor Agonist
Retatrutide for Chronic Kidney Disease and Obesity
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 24
Awards & highlights
Study Summary
This trial will investigate how retatrutide affects kidney health in people with obesity/overweight, CKD, and/or T2D over 31 weeks.
Who is the study for?
This trial is for adults with overweight or obesity and chronic kidney disease, with or without Type 2 Diabetes. Participants must have a BMI ≥27 kg/m², stable treatment for at least 90 days, and specific HbA1c levels depending on their diabetes status. Exclusions include recent significant weight change, certain diabetes medications within the last 90 days, and a history of cancer in the past five years.Check my eligibility
What is being tested?
The study tests Retatrutide (LY3437943) to see its effects on kidney function in people who are overweight or obese with chronic kidney disease. Some participants will receive LY3437943 while others will get a placebo (a substance with no active drug). The trial lasts approximately 31 weeks.See study design
What are the potential side effects?
While not specified here, common side effects from similar drugs may include gastrointestinal symptoms like nausea or vomiting, potential allergic reactions, injection site reactions if applicable, and possibly changes in blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Glomerular Filtration Rate (GFR)
Secondary outcome measures
Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)
Change from Baseline in Body Weight
Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))
+14 moreSide effects data
From 2022 Phase 2 trial • 281 Patients • NCT0486778520%
Decreased appetite
20%
Nausea
15%
Diarrhoea
11%
Constipation
11%
Vomiting
11%
Upper respiratory tract infection
11%
Urinary tract infection
7%
Fatigue
7%
Dyspepsia
4%
Anaemia
4%
Covid-19
4%
Lipase increased
4%
Dizziness
4%
Weight decreased
2%
Cellulitis
2%
Diabetic ketoacidosis
2%
Abdominal pain
2%
Eructation
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3437943 (2 mg)
8 mg LY3437943 (2 mg)
Placebo
1.5 Milligram (mg) Dulaglutide
0.5 mg LY3437943
4 mg LY3437943 (2 mg)
4 mg LY3437943 (4 mg)
8 mg LY3437943 (4 mg)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3437943Experimental Treatment1 Intervention
Participants will receive multiple doses of LY3437943 subcutaneously (SC)
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive LY3437943
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3437943
2022
Completed Phase 2
~950
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,479 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost or gained more than 11 pounds in the last 3 months.I have hepatitis.I have had or am planning to have surgery for weight loss.I have Type 1 Diabetes.I have had cancer within the last 5 years.I have been diagnosed with chronic kidney disease.I have not used specific diabetes medications in the last 90 days.My diabetes is under control with diet, exercise, or up to 3 medications.My diabetes is either not present with an HbA1c under 6.5%, or it's managed with up to 3 pills and possibly insulin.
Research Study Groups:
This trial has the following groups:- Group 1: LY3437943
- 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.
Has LY3437943 been granted clearance by the Food and Drug Administration?
"Based on the information available, LY3437943 received a rating of 2 in regard to safety as this is currently only a Phase 2 trial with limited data supporting efficacy."
Answered by AI
How many venues are administering this clinical experiment?
"This medical study is now recruiting participants across 20 locations, spanning from Montclair to New Port Richey and beyond. It would be prudent for those interested in joining the trial to select a nearby site so as to limit their travel commitment."
Answered by AI
Is recruitment for this experimental program ongoing?
"This particular medical experiment, which was initially publicised on July 17th 2023 and last updated June 30th 2023 is not currently accepting candidates. Fortunately, there are nearly three thousand other trials looking for volunteers presently."
Answered by AI
Who else is applying?
What site did they apply to?
Catalina Research Institute, LLC
Tranquility Research
Palm Research Center Tenaya
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'D LIKE TO TRY. To help with others. Possible benefit to myself and other people.
PatientReceived 2+ prior treatments
Anything that can help with kidney disease is a good thing. Wanting to find a medication that will help me control my diabetes.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Duration and compensation?
PatientReceived no prior treatments
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