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CagriSema for Chronic Kidney Disease and Type 2 Diabetes in Obesity
Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening
Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 milliliters per minutes per 1.73^m^2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed by central laboratory at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 32)
Awards & highlights
Study Summary
This trial will test if CagriSema can lower kidney damage in people with CKD, T2D and obesity, compared to existing medicines and a placebo.
Who is the study for?
Adults over 18 with chronic kidney disease, type 2 diabetes, and a BMI of at least 27 can join this study. They must have some kidney function left (eGFR ≥15 to <90), not be on dialysis, and have been treated with specific blood pressure meds for at least a month. Pregnant women or those planning pregnancy are excluded.Check my eligibility
What is being tested?
The trial is testing CagriSema against Semaglutide, Cagrilintide, and placebo in reducing kidney damage for people with CKD and T2D who are overweight. Treatments are assigned randomly like flipping a coin, and neither participants nor doctors know which one they get.See study design
What are the potential side effects?
Potential side effects may include digestive issues such as nausea or diarrhea due to the nature of these medications affecting glucose metabolism but will vary based on individual reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 27 or higher.
Select...
My kidney function is reduced but not severely impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to end of study (week 32)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 32)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in urinary albumin-to-creatinine ratio (UACR)
Secondary outcome measures
Achievement of greater than or equal to (≥) 5 % weight reduction
Achievement of ≥ 10 % weight reduction
Change in diastolic blood pressure
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 2.4 mgExperimental Treatment2 Interventions
Participants will receive semaglutide 2.4 mg and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Group II: Cagrilintide 2.4 mgExperimental Treatment2 Interventions
Participants will receive cagrilintide 2.4 mg and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Group III: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions
Participants will receive 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive 2.4 mg placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2019
Completed Phase 4
~5160
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,450 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,208 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health care facilities are presently conducting this research endeavor?
"Currently, this clinical trial is being conducted at 68 different sites. Notable locations include Fresno, San Dimas and San Ramon to name a few. If you choose to participate in the study it would be advisable to select a nearby location so that travel needs can be kept minimal."
Answered by AI
Are there any opportunities open to participants for this clinical trial?
"As highlighted by clinicaltrials.gov, this medical trial has ceased recruitment for the time being; it was initially posted on April 1st of 2024 and last updated November 9th 2023. Thankfully, there are other 3,068 trials that are still recruiting individuals at present."
Answered by AI
Is CagriSema 2.4 mg/2.4 mg associated with any acute adverse effects?
"Based on the available data, our team has assigned CagriSema 2.4 mg/2.4mg a score of two for safety; this is because Phase 2 trials demonstrate that its use is safe but not necessarily effective."
Answered by AI
Who else is applying?
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I just want to see if my kidney problem can be improved. I am currently on Moiunjaro because I could not tolerate Janumet.
PatientReceived no prior treatments
I want to try something that will help me with my issues. Medicine costs for this is so expensive and I can not afford it.
PatientReceived no prior treatments
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