Rationale, design and baseline characteristics of REMODEL, a mechanism-of-action trial with semaglutide in people with type 2 diabetes and chronic kidney disease

What Was Tested

The paper reports a study of Semaglutide, published as a clinical study.

Type 2 diabetes (T2D) is the leading cause of chronic kidney disease (CKD) and kidney failure globally.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

The REMODEL trial (NCT04865770) is a 52-week placebo-controlled, double-blind, parallel-group, randomized trial in adults with T2D and CKD.

A subgroup had kidney biopsies at baseline and at the end of the treatment for tissue-based interrogation, including single nucleus and spatial transcriptomics, pathology and advanced histological assessment.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter and parallel-group study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

A placebo (an inactive look-alike) gave the Semaglutide group a baseline to be compared against.

More than one site took part, so the participants came from several places.

The co-primary outcomes were magnetic resonance imaging (MRI) based, including change in kidney oxygenation, perfusion and inflammation.

Secondary outcomes include change from baseline in creatine clearance rate, urinary sodium excretion, albumin excretion rate and kidney fibrosis and blood flow parameters measured by MRI.

What Was Measured

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Glomerular Filtration Rate, Glucagon-Like Peptides, Glycated Hemoglobin, Hypoglycemic Agents, Prognosis and Renal Insufficiency, Chronic.

Author keywords: functional magnetic resonance imaging, gene expression, incretin therapy, kidney and nutrient-stimulated hormone (NuSH) therapy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association), a journal based in England.

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