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)

What Was Tested

This registered phase 3 trial tested Semaglutide.

The researchers are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes.

The researchers 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.

It had two arms (groups): one (experimental) and one (placebo comparator).

Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).

Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).

The registry classes the interventions as drug.

Who Took Part

106 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Age above or equal to 18 years at the time of signing informed consent. Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening. Depending on biopsy/non-biopsy population:.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: use of any glucagon-like peptide 1 receptor agonist (glp-1 ra) within 30 days prior to screening; A prior solid organ transplant or awaiting solid organ transplant; myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-04-28 with completion listed for 2024-11-21.

It ran at 49 sites in United States (20), France (6), Italy (5), Poland (5), South Africa (4) and Spain (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*) (time frame: Baseline (week 0), End of treatment (week 52)). Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*) (time frame: Baseline (week 0), End of treatment (week 52)). Change in Global Kidney Perfusion (MRI) (time frame: Baseline (week 0), End of treatment (week 52)).

It also tracked 9 secondary outcomes, for example Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy), Change in Glomerular Basement Membrane Width (Kidney Biopsy), Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI), Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI), Change in Mean Renal Artery Resistive Index (RARI) (MRI) and Change in Mean Arterial Flow (MRI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 106 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.