Trial results for semaglutide in patients with Type 2 Diabetes and Chronic Kidney Disease were posted on ClinicalTrials.gov on 2026-01-14. The Phase 3 REMODEL trial (NCT04865770) investigated changes in kidney oxygenation, finding no statistically significant difference between semaglutide and placebo for this outcome.
Background
The REMODEL trial (NCT04865770) aimed to investigate how semaglutide works in the kidneys of people with Type 2 Diabetes and Chronic Kidney Disease. The study sought to understand the potential effects of semaglutide on kidney function, specifically focusing on kidney oxygenation.
Trial design
The REMODEL trial (NCT04865770) was a Phase 3 study that enrolled 106 participants with Type 2 Diabetes and Chronic Kidney Disease. Participants were randomized to receive either semaglutide or placebo, administered once weekly via injection. The study's objective was to assess changes in kidney oxygenation using Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI).
Key results
The study evaluated the change in kidney oxygenation, measured by BOLD MRI (R2*), in both the cortex and medulla regions of the kidney. The geometric mean ratios for change in kidney oxygenation (cortex) were 0.98 for the semaglutide 1.0 mg group across various measurements, compared to 1.00, 0.99, and 1.01 for the placebo group. For the medulla, geometric mean ratios for semaglutide 1.0 mg were 0.99, 0.98, and 0.99, versus 1.01, 1.02, and 1.02 for placebo.
Statistical analyses using ANCOVA showed the following treatment ratios (semaglutide vs. placebo) for kidney oxygenation:
- For bilateral cortex oxygenation, the treatment ratio was 0.98 (95.0% CI: 0.96 to 1.01), with a p-value of 0.1333.
- For right cortex oxygenation, the treatment ratio was 0.99 (95.0% CI: 0.96 to 1.01), with a p-value of 0.2487.
- For left cortex oxygenation, the treatment ratio was 0.97 (95.0% CI: 0.94 to 1.0), with a p-value of 0.0907.
- For bilateral medulla oxygenation, the treatment ratio was 0.99 (95.0% CI: 0.94 to 1.03), with a p-value of 0.5619.
- For right medulla oxygenation, the treatment ratio was 0.97 (95.0% CI: 0.93 to 1.02), with a p-value of 0.2774.
- For left medulla oxygenation, the treatment ratio was 0.99 (95.0% CI: 0.94 to 1.04), with a p-value of 0.7924.
None of these analyses demonstrated a statistically significant difference in kidney oxygenation between the semaglutide and placebo groups, as all p-values were greater than 0.05.
What this means
The results of the REMODEL trial indicate that semaglutide did not show a statistically significant effect on kidney oxygenation in patients with Type 2 Diabetes and Chronic Kidney Disease when compared to placebo. The treatment ratios for changes in kidney oxygenation were close to 1.00, and the confidence intervals consistently crossed 1.00, suggesting no clear benefit or detriment on this specific physiological measure within the study's parameters. These findings contribute to the understanding of semaglutide's effects in this patient population, particularly concerning its direct impact on kidney oxygenation.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04865770, titled "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)," were posted on 2026-01-14 on clinicaltrials.gov.