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New study reveals how diabetes drug semaglutide may protect kidneys

NCT ID NCT04865770

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how semaglutide, a diabetes medicine, affects the kidneys in people with type 2 diabetes and chronic kidney disease. 106 participants received either semaglutide or a placebo injection once a week for about a year. Researchers used MRI scans, blood and urine tests, and kidney biopsies to measure changes in kidney oxygen, blood flow, and inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

106 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 the day of screening. * HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75 mmol/mol). * Depending on biopsy/non-biopsy population: 1. For subjects in the non-biopsy population: Serum creatinine-based eGFR greater than 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 greater than 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-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment is contraindicated or not tolerated.Treatment dose must be stable for at least 28 days prior to screening. Exclusion Criteria: * Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days prior to screening. * A prior solid organ transplant or awaiting solid organ transplant. * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * Presence or history of malignant neoplasms (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening. * Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and Visit 2. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 days prior to screening. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed. * Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible. * Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Diabetes mellitus type 2

Contacts and locations

Locations

  • Academic Medical Research Institute

    Los Angeles, California, 90022, United States

  • Advent Health-Res Inst

    Orlando, Florida, 32804, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Azienda Ospedaliera di Padova Clin.Med.3

    Padova, 35128, Italy

  • Azienda Ospedaliero - Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Centre Hospitalier Universitaire Amiens Picardie-Site Sud

    Amiens, 80054, France

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

    Grenoble - Cédex 09, 38043, France

  • Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume

    Bois-Guillaume, 76230, France

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059, France

  • Centrum Medyczne "Diabetika"

    Radom, 26-600, Poland

  • Chu de Reims-Hopital Maison Blanche

    Reims, 51092, France

  • Cleveland Clinic_Cleveland

    Cleveland, Ohio, 44195, United States

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111, United States

  • Emory University Hsptl - Atlanta

    Atlanta, Georgia, 30322, United States

  • Endeavor Health Glenbook Hosp

    Evanston, Illinois, 60201, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • In-Vivo Sp. z o.o.

    Bydgoszcz, 85-048, Poland

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132, Italy

  • LMC ClinRsrh Inc.Brampton

    Brampton, Ontario, L6S 0C6, Canada

  • Lenmed Shifa Private Hospital

    Durban, KwaZulu-Natal, 4901, South Africa

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630, France

  • Maxwell Centre

    Durban, KwaZulu-Natal, 4001, South Africa

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny

    Warsaw, 04-749, Poland

  • N America Res Inst - San Dimas

    San Dimas, California, 91773, United States

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233, United States

  • Nefrologisk Klinik P 2132

    Copenhagen, 2100, Denmark

  • North Suburban Nephrology LLC

    Gurnee, Illinois, 60031, United States

  • Precise Clinical Solutions (Pty) Ltd

    Durban, KwaZulu-Natal, 4092, South Africa

  • Presidio Ospedaliero Cisanello

    Pisa, 56124, Italy

  • Prof Rayner_Division of Nephrology

    Cape Town, Western Cape, 7925, South Africa

  • Prolato Clinical Research Cntr

    Houston, Texas, 77054, United States

  • Providence Medical Research Center

    Spokane, Washington, 99204, United States

  • Prywatny Gabinet Janusz Gumprecht

    Zabrze, 41-800, Poland

  • Rigshospitalet - Nefrologisk Klinik P 2132

    Copenhagen, 2100, Denmark

  • Roderick A. Comunale II MD Inc.

    National City, California, 91950, United States

  • Steno Diabetes Center Copenhagen

    Herlev, 2730, Denmark

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • UC Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • UHN-Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

  • Univ of Washington Med Ctr

    Seattle, Washington, 98195, United States

  • University of Arizona-CaTs

    Tucson, Arizona, 85724, United States

  • University of Minnesota Health Clinical

    Minneapolis, Minnesota, 55455, United States

  • University of Texas San Antonio

    San Antonio, Texas, 78284, United States

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

    Szczecin, 70-111, Poland

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