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

Phase 3
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment (week 52
Awards & highlights

REMODEL 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.Check my eligibility
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.See study design
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.

REMODEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function, measured by eGFR, is between 40 and 75 mL/min.
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My kidney function, measured by eGFR, is between 30 and 75 mL/min.
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I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.
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My kidney function, measured by eGFR, is between 30 and 75 mL/min.
Select...
I was diagnosed with type 2 diabetes more than 6 months ago.
Select...
I am either male or female.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by eGFR, is between 30 and 75 mL/min.

REMODEL Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

REMODEL 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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,709 Total Patients Enrolled
Clinical Transparency (Dept.1452)Study DirectorNovo Nordisk A/S
3 Previous Clinical Trials
658 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a study like this ever been done before?

"Semaglutide has had a long journey to market, with the first clinical trial being performed in 2018. However, after Phase 4 drug approval was received in late 2018, 59 active trials for Semaglutide have cropped up across 766 cities and 55 countries."

Answered by AI

Did the FDA sign off on Semaglutide?

"Despite being a Phase 3 trial, there is already some data suggesting semaglutide's efficacy. Furthermore, the medication has gone through multiple rounds of testing for safety, so it received a score of 3 from our team."

Answered by AI

How many people are being included in this clinical trial?

"The clinical trial is currently ongoing, as reflected by the information available on clinicaltrials.gov. This specific study was posted on 4/28/2021 and last updated 5/27/2022. There are 105 participants enrolled at 7 different sites."

Answered by AI

In how many different places is this trial taking place?

"Currently, there are 7 sites where patients can enroll in this study. The locations of these centres are San Dimas, Aurora, Toronto and 4 other undisclosed cities. If you wish to participate in this trial, it might be best to select a site that is close to your home to reduce travel time and costs."

Answered by AI

Are we still able to include new test subjects in this research?

"That is correct, the online information shows that this research project is still recruiting people. The trial was first advertised on April 28th 2021 and updated as recently as May 27th 2022. There are 7 sites for this study and they are looking to enroll 105 patients in total."

Answered by AI

What is the primary goal of this experiment?

"The primary goal of this 52-week clinical trial is to observe the change in kidney inflammation via MRI T1 mapping. Additionally, researchers will be measuring the ADC in the medulla, glomerular basement membrane width, and mean arterial flow as secondary objectives."

Answered by AI

What is the primary indication for Semaglutide?

"Semaglutide is most often used as a weight management tool for obese patients, but it can also help those with other conditions like type 2 diabetes who are following a calorie-restricted diet and exercising regularly."

Answered by AI

Could you provide context for Semaglutide's efficacy by referencing other clinical trials?

"Semaglutide was first researched in 2018 at the Novo Nordisk Investigational Site. As of now, 124 studies have been completed with 59 more ongoing. The majority of these live trials are based in Toronto, Canada."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
California
Other
Texas
How old are they?
18 - 65
65+
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
How many prior treatments have patients received?
3+
1
2
0

Why did patients apply to this trial?

I have type 2 diabetes. I am very motivated to loose weight and lower my A1c.
PatientReceived no prior treatments
I can not afford semi gluten treatment this would give me access to it. I want to reduce any complications from type II diabetes to my kidneys or any other part of my body.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is it paid for ? How long do screening sessions take? How often and how long Will appointments be?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
~15 spots leftby Oct 2024