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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE3 INTERVENTIONAL NCT04865770

A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys. Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance. Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week. The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations. Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours. The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.

Interventions

Name: Semaglutide
Type: DRUG
Description: Semaglutide given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.
Name: Placebo (Semaglutide)
Type: DRUG
Description: Placebo (Semaglutide) given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.

Primary Outcomes

Measure: Change in kidney oxygenation (cortex), BOLD (blood oxygenation-level dependent) MRI ( magnetic resonance imaging )
TimeFrame: From baseline (week 0) to end of treatment (week 52)
Description: ratio
Measure: Change in kidney oxygenation (medulla), BOLD MRI(R2)
TimeFrame: From baseline (week 0) to end of treatment (week 52)
Description: ratio
Measure: Change in global kidney perfusion (MRI)
TimeFrame: From baseline (week 0) to end of treatment (week 52)
Description: ratio
Measure: Change in kidney inflammation (cortex), T1 mapping (MRI)
TimeFrame: From baseline (week 0) to end of treatment (week 52)
Description: ratio
Measure: Change in kidney inflammation (medulla), T1 mapping (MRI)
TimeFrame: From baseline (week 0) to end of treatment (week 52)
Description: ratio

Trial Information

NCT ID

NCT04865770

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025