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COMPLETED Phase 3

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)

NCT04865770 · View on ClinicalTrials.gov ↗

Study 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

  • DRUG Semaglutide
  • DRUG Placebo (Semaglutide)

Study Locations (20)

Texas

  • Prolato Clinical Research Cntr — Houston
  • Sun Research Institute — San Antonio
  • NE Clin Res of San Antonio — San Antonio
  • University of Texas San Antonio — San Antonio

California

  • Academic Medical Research Institute — Los Angeles
  • Roderick A. Comunale II MD Inc. — National City
  • N America Res Inst - San Dimas — San Dimas

Georgia

  • Atlanta Diabetes Associates — Atlanta
  • Emory University Hsptl - Atlanta — Atlanta

Illinois

  • Endeavor Health Glenbook Hosp — Evanston
  • North Suburban Nephrology LLC — Gurnee

Washington

  • Univ of Washington Med Ctr — Seattle
  • Providence Medical Research Center — Spokane

Arizona

  • University of Arizona-CaTs — Tucson

Colorado

  • UC Anschutz Medical Campus — Aurora

Florida

  • Advent Health-Res Inst — Orlando

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2021-04-28
Est. Completion 2024-11-21
Phase Phase 3

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04865770

The ClinicalTrials.gov registry entry for NCT04865770 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions — of which Semaglutide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04865770 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04865770 about?

NCT04865770 is a clinical study 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)". 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 partic...

What is the current status of trial NCT04865770?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2021-04-28. Estimated completion is 2024-11-21.

What conditions does trial NCT04865770 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Chronic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04865770?

The interventions under investigation include: Semaglutide (DRUG), Placebo (Semaglutide) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04865770?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04865770 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial