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)

Conditions

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  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.
• Placebo (Semaglutide) — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 28, 2021

Status verified

Feb 2026

Primary completion

Nov 21, 2024

Completion

Nov 21, 2024

Study Design

Enrollment

106 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 1.0 mg OW
  Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).
• Placebo Comparator: Placebo (Semaglutide) 1.0 mg OW
  Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).

Primary Outcome Measure

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) ]

Locations (20)

Related coverage on Hipa.ai

• Semaglutide in Type 2 Diabetes, CKD: No Significant Impact on Kidney Oxygenation
  Semaglutide · Jan 14, 2026 · ClinicalTrials.gov

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