← Back to Search

Semaglutide for Type 2 Diabetes with Chronic Kidney Disease (REMODEL Trial)

Phase 3
Waitlist Available
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
Age above or equal to 18 years at the time of signing informed consent.
For subjects in the biopsy sub-population: Serum creatinine-based eGFR greater than or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI)
Must not have
Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment (week 52
Awards & highlights
Pivotal Trial

Summary

This trial is testing if semaglutide can help fight chronic kidney disease in people with type 2 diabetes. Participants will be randomly assigned to receive either semaglutide or placebo, and will be monitored for a year through clinic visits and phone calls. Blood and urine samples will be taken, and participants will also have MRI scans.

Who is the study for?
Adults with type 2 diabetes and chronic kidney disease can join this study. They must have a certain level of albumin in their urine, stable kidney function within specific limits, and controlled blood sugar levels. Participants should be on steady doses of medication for kidney protection but cannot have used certain diabetes drugs recently or have had recent major cardiovascular events.
What is being tested?
The REMODEL trial is testing Semaglutide against a placebo to see if it helps the kidneys in people with type 2 diabetes. Patients will inject themselves weekly for about a year, attend clinic visits, provide urine samples, and undergo MRI scans of their kidneys.
What are the potential side effects?
While not specified here, common side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and loss of appetite. Side effects from MRIs are rare but could include discomfort or reactions to contrast agents if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My kidney function, measured by eGFR, is between 40 and 75 mL/min.
Select...
My kidney function, measured by eGFR, is between 30 and 75 mL/min.
Select...
I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by eGFR, is between 30 and 75 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a genetic or autoimmune kidney disease, like polycystic kidney disease or glomerulonephritis.
Select...
I am taking both an ACE inhibitor and an ARB medication.
Select...
I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment (week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment (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
Change in global kidney perfusion (MRI)
Change in kidney inflammation (cortex), T1 mapping (MRI)
Change in kidney inflammation (medulla), T1 mapping (MRI)
+2 more
Secondary study objectives
Change in ADC (apparent diffusion coefficient) (cortex) (MRI)
Change in ADC (medulla) (MRI)
Change in albumin excretion rate (urinalysis)
+6 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 1.0 mg OWExperimental Treatment1 Intervention
Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).
Group II: Placebo (Semaglutide) 1.0 mg OWPlacebo Group1 Intervention
Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,552 Previous Clinical Trials
2,444,955 Total Patients Enrolled
Clinical Transparency (Dept.1452)Study DirectorNovo Nordisk A/S
3 Previous Clinical Trials
665 Total Patients Enrolled
Clinical Transparency (Dept.2834)Study DirectorNovo Nordisk A/S

Media Library

Placebo (Semaglutide) Clinical Trial Eligibility Overview. Trial Name: NCT04865770 — Phase 3
Type 2 Diabetes Research Study Groups: Semaglutide 1.0 mg OW, Placebo (Semaglutide) 1.0 mg OW
Type 2 Diabetes Clinical Trial 2023: Placebo (Semaglutide) Highlights & Side Effects. Trial Name: NCT04865770 — Phase 3
Placebo (Semaglutide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04865770 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04865770 — Phase 3
~23 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top