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)

Last updated: June 17, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Nephropathy

Treatment

Semaglutide

Placebo (Semaglutide)

Clinical Study ID

NCT04865770
NN9535-4662
2020-000828-19
U1111-1248-7912
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 theday of screening.

  • HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75mmol/mol).

  • Depending on biopsy/non-biopsy population:

  1. For subjects in the non-biopsy population: Serum creatinine-based eGFR greaterthan or equal to 30 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).

  2. For subjects in the biopsy sub-population: Serum creatinine-based eGFR greaterthan or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).

  • UACR ( Urinary albumin-to-creatinine ratio ) greater than or equal to 20 and below 5000 mg/g.

  • Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosteronesystem (RAAS) blocking agent including an angiotensin converting enzyme (ACE)inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment iscontraindicated or not tolerated.Treatment dose must be stable for at least 28 daysprior to screening.

Exclusion

Exclusion Criteria:

  • Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days priorto screening.

  • A prior solid organ transplant or awaiting solid organ transplant.

  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris ortransient ischaemic attack within 180 days prior to the day of screening.

  • Presence or history of malignant neoplasms (other than basal or squamous cell skincancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 yearsprior to the day of screening.

  • Congenital or hereditary kidney diseases including polycystic kidney disease,autoimmune kidney diseases including glomerulonephritis or congenital urinary tractmalformations.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within the past 90 days prior to screening or inthe period between screening and Visit 2. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.

  • Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 daysprior to screening. Stable treatment with acetylsalicylic acid for prevention ofcardiovascular events and occasional use of propionic acid derivatives drugs (e.g.ibuprofen) is allowed.

  • Any contraindication for MRI according to standard checklist used in clinicalroutine, including claustrophobia or metallic foreign bodies, metallic implants,internal electrical devices, or permanent makeup/tattoos that cannot be declared MRcompatible.

  • Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers).

Study Design

Total Participants: 106
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
April 28, 2021
Estimated Completion Date:
November 21, 2024

Connect with a study center

  • Novo Nordisk Investigational Site

    Toronto, Ontario M5G 2N2
    Canada

    Active - Recruiting

  • UHN-Toronto General Hospital

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • Nefrologisk Klinik P 2132

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Steno Diabetes Center Copenhagen

    Herlev, 2730
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire Amiens Picardie-Site Sud

    AMIENS cedex 1, 80054
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    AMIENS cedex 1, 80054
    France

    Completed

  • Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume

    Bois-Guillaume, 76230
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Bois-Guillaume, 76230
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2

    Grenoble - Cédex 09, 38043
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Grenoble - Cédex 09, 38043
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Reims-Hopital Maison Blanche

    Reims, 51092
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Reims, 51092
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse, 31059
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Istituto Scientifico San Raffaele

    Milano, MI 20132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, MI 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Padova Clin.Med.3

    Padova, 35128
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria Sant'Andrea

    Roma, 00189
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00189
    Italy

    Active - Recruiting

  • In-Vivo Sp. z o.o.

    Bydgoszcz, 85-048
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bydgoszcz, 85-048
    Poland

    Active - Recruiting

  • Centrum Medyczne "Diabetika"

    Radom, 26-600
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Radom, 26-600
    Poland

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Szczecin, 70-111
    Poland

    Suspended

  • SPSK nr 2 PUM, Kl. Nefrologii, Transplantologii i Ch. Wewn.

    Szczecin, 70-111
    Poland

    Site Not Available

  • Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny

    Warszawa, 04-749
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 04-749
    Poland

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • Prywatny Gabinet Janusz Gumprecht

    Zabrze, 41-800
    Poland

    Site Not Available

  • Maxwell Centre

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4092
    South Africa

    Active - Recruiting

  • Precise Clinical Solutions (Pty) Ltd

    Durban, KwaZulu-Natal 4092
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape 7925
    South Africa

    Active - Recruiting

  • Prof Rayner

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Prof Rayner_Division of Nephrology

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Tucson, Arizona 85724
    United States

    Site Not Available

  • University of Arizona-CaTs

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90022
    United States

    Suspended

  • N America Res Inst - San Dimas

    San Dimas, California 91773
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Dimas, California 91773
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UC Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Advent Health-Res Inst

    Orlando, Florida 32804
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Clinical Research Consultants, LLC

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Prolato Clinical Research Cntr

    Houston, Texas 77054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Live Oak, Texas 78233
    United States

    Site Not Available

  • NE Clin Res of San Antonio

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Univ of Washington Med Ctr

    Seattle, Washington 98195
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Providence Medical Research Center

    Spokane, Washington 99204
    United States

    Site Not Available

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