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REMODEL

CompletedPhase 3Results posted

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)

Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

49

Recruiting sites

-

Actual enrollment

106

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

eGFR ≥30UACR ≥20

Primary endpoints

Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent MagneticKidney Oxygenation (Medulla), BOLD MRI (R2*)Global Kidney Perfusion (MRI)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04865770
Org study IDNN9535-4662
Secondary ID2020-000828-19
Secondary IDU1111-1248-7912World Health Organization (WHO)

Timeline

Milestones

Study start2021-04-28actual
Study first posted2021-04-29actual
Primary completion2024-11-21actual
Study completion2024-11-21actual
Results first posted2026-01-14actual
Last update posted2026-02-10actual

Assets

Investigational agents

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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).

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney
22
Other (unclassified)
6

Renal / kidney

22 endpoints
Primary/registry result

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)

change from baseline, improvement

Posted result

GroupGeometric mean · Ratio of kidney oxygenation (cortex)95% CI
Semaglutide 1.0 mgBilateral cortex0.98-
Right cortex0.98-
Left cortex0.98-
PlaceboBilateral cortex1.00-
Right cortex0.99-
Left cortex1.01-
Treatment ratio0.9895% CI0.96 - 1.01p0.1333ANCOVA

Bilateral cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.

Treatment ratio0.9995% CI0.96 - 1.01p0.2487ANCOVA

Right cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.

Treatment ratio0.9795% CI0.94 - 1.00p0.0907ANCOVA

Left cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.

Primary/registry result

Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupGeometric mean · Ratio of kidney oxygenation (medulla)95% CI
Semaglutide 1.0 mgBilateral medulla0.99-
Right medulla0.98-
Left medulla0.99-
PlaceboBilateral medulla1.01-
Right medulla1.02-
Left medulla1.02-
Treatment ratio0.9995% CI0.94 - 1.03p0.5619ANCOVA

Bilateral medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio0.9795% CI0.93 - 1.02p0.2774ANCOVA

Right medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio0.9995% CI0.94 - 1.04p0.7924ANCOVA

Left medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Primary/registry result

Change in Global Kidney Perfusion (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupGeometric mean · Ratio of global kidney perfusion95% CI
Semaglutide 1.0 mgBilateral kidney1.03-
Right kidney1.04-
Left kidney1.02-
PlaceboBilateral kidney0.99-
Right kidney0.98-
Left kidney1.01-
Treatment ratio1.1095% CI0.98 - 1.24p0.0958ANCOVA

Bilateral kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.1795% CI1.03 - 1.33p0.0145ANCOVA

Right kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.0695% CI0.94 - 1.21p0.3311ANCOVA

Left kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Primary/registry result

Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

ratio, improvement

Posted result

GroupGeometric mean · Ratio of kidney inflammation (cortex)95% CI
Semaglutide 1.0 mgBilateral cortex1.01-
Right cortex1.01-
Left cortex1.01-
PlaceboBilateral cortex1.01-
Right cortex1.01-
Left cortex1.01-
Treatment ratio1.0095% CI0.98 - 1.02p0.8651ANCOVA

Bilateral cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.0095% CI0.98 - 1.02p0.7240ANCOVA

Right cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.0095% CI0.98 - 1.02p0.7195ANCOVA

Left cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Primary/registry result

Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

ratio, improvement

Posted result

GroupGeometric mean · Ratio of kidney inflammation (medulla)95% CI
Semaglutide 1.0 mgBilateral medulla1.00-
Right medulla1.00-
Left medulla1.00-
PlaceboBilateral medulla1.00-
Right medulla1.01-
Left medulla1.00-
Treatment ratio1.0095% CI0.98 - 1.02p0.9335ANCOVA

Bilateral medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.0095% CI0.98 - 1.01p0.6517ANCOVA

Right medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Treatment ratio1.0095% CI0.98 - 1.02p0.9017ANCOVA

Left medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.

Primary/protocol endpoint

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)

change from baseline, improvement

Primary/protocol endpoint

Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Primary/protocol endpoint

Change in Global Kidney Perfusion (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Primary/protocol endpoint

Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Primary/protocol endpoint

Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Secondary/registry result

Change in Glomerular Basement Membrane Width (Kidney Biopsy)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupMean · Nanometer (nm)95% CI
Semaglutide 1.0 mg-72.67-
Placebo-8.66-
Secondary/registry result/low confidence

Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

ratio, descriptive

Posted result

GroupGeometric mean · Ratio of ADC (cortex)95% CI
Semaglutide 1.0 mgBilateral cortex1.00-
Left cortex1.01-
Right cortex0.98-
PlaceboBilateral cortex0.94-
Left cortex0.96-
Right cortex0.93-
Secondary/registry result

Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupGeometric mean · Ratio of ADC (medulla)95% CI
Semaglutide 1.0 mgBilateral medulla0.98-
Left medulla0.99-
Right medulla0.98-
PlaceboBilateral medulla0.94-
Left medulla0.95-
Right medulla0.93-
Secondary/registry result

Change in Mean Renal Artery Resistive Index (RARI) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupGeometric mean · Ratio of RARI95% CI
Semaglutide 1.0 mgBilateral renalartery0.97-
Right renalartery0.98-
Left renalartery0.97-
PlaceboBilateral renalartery1.01-
Right renalartery1.01-
Left renalartery1.01-
Secondary/registry result

Change in Albumin Excretion Rate (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupMean · Milligrams per day (mg/d)95% CI
Semaglutide 1.0 mg-81.9-
Placebo-233.2-
Secondary/registry result

Change in Kidney Function (Creatinine Clearance) (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Posted result

GroupMean · Milliliter per minute95% CI
Semaglutide 1.0 mg3.8-
Placebo-12.6-
Secondary/protocol endpoint

Change in Glomerular Basement Membrane Width (Kidney Biopsy)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Renal Artery Resistive Index (RARI) (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Albumin Excretion Rate (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Secondary/protocol endpoint

Change in Kidney Function (Creatinine Clearance) (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, improvement

Other (unclassified)

6 endpoints
Secondary/registry result/low confidence

Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Posted result

GroupNumber · log2 fold-change95% CI
Semaglutide 1.0 mg/PlaceboCNT-2, RSPO33.468216523-
CNT-Immune, SLC8A1-AS12.8531071-
EC-GC-1, KCNK6-1.952545192-
EC-GC-1, EMC10-2.485824696-
EC-GC-1, ENSG000002861451.831300888-
EC-GC-1, LMF1-1.528463786-
EC-GC-1, ANKUB11.783402404-
EC-GC-1, AHNAK-1.368952211-
EC-GC-1, ENSG000002861501.318309657-
EC-GC-1, NSUN6-1.464540152-
EC-GC-1, TFCP2L1-2.24516792-
EC-GC-1, ENSG00000274422-1.860725608-
EC-GC-1, DPYD-AS11.996950045-
EC-GC-1, ENSG000002481382.110414741-
EC-GC-1, ACSM2B-1.785467699-
EC-GC-1, CCNH1.033873239-
EC-GC-1, QTRT1-2.415240141-
EC-GC-1, CROCCP3-1.254541813-
EC-GC-1, ENSG000002510341.750285729-
EC-GC-1, LSAMP-2.439268964-
EC-GC-1, LHX1-DT-4.256689925-
EC-GC-1, ESRRG-1.527414037-
EC-GC-1, CNTNAP2-2.377391827-
EC-GC-1, ENSG000002849661.665764749-
EC-GC-1, BICC1-1.445239386-
EC-GC-1, GNA14-AS11.192645521-
EC-GC-1, GUSBP11-1.318511642-
EC-GC-1, ENSG000002337831.668536087-
EC-GC-1, SEMA6A-AS11.183886707-
EC-GC-1, RBMS3-AS21.572052032-
EC-GC-1, ENSG00000286147-4.468841041-
EC-GC-1, LINC00342-1.151143461-
EC-GC-1, IRF3-1.566408786-
EC-GC-1, ENSG000002492071.35685803-
EC-GC-1, CRADD-AS11.972404772-
EC-GC-1, TOX3-2.206055055-
EC-GC-1, ENSG000002864581.271036656-
EC-GC-1, SLC12A3-2.531722898-
EC-GC-1, TALAM11.235573321-
EC-GC-1, PCDH171.107442597-
EC-GC-1, ATP13A31.078246118-
EC-GC-1, ENSG00000231772-2.382264501-
EC-GC-1, FBXL19-2.166973377-
EC-GC-1, ENSG000002544201.74612131-
EC-GC-1, SPC251.329461228-
EC-GC-1, SMAD41.13655744-
EC-GC-1, UFM11.20264148-
EC-GC-1, ENSG000002595642.071724947-
EC-GC-1, SHOC11.634369451-
EC-GC-1, MEF2C-AS21.753288691-
EC-GC-1, ENSG000002858011.440844025-
EC-GC-1, FAM228B-1.22996414-
EC-GC-1, GLS0.868999317-
EC-GC-1, GDPD4-6.564026305-
EC-GC-1, INSYN2A1.759769032-
EC-GC-1, TNFRSF14-1.254004029-
EC-GC-1, PRX-1.199880651-
EC-GC-1, PNN-1.024604708-
EC-GC-1, KCNQ1OT1-0.794847103-
EC-GC-1, ACAP3-1.44397269-
EC-GC-1, BASP1-AS1-4.83539932-
EC-GC-1, RBFOX1-1.706411849-
EC-GC-1, CCDC90B-AS1-1.678217382-
EC-GC-1, ENSG000002404991.514399208-
EC-GC-1, LINC030761.545248095-
EC-GC-1, LINC01409-1.022992954-
EC-GC-1, CCT41.455396063-
EC-GC-1, CDC730.802691458-
EC-GC-1, NUMA1-0.931923316-
EC-GC-1, FLT4-0.935590968-
EC-GC-1, PDLIM50.764926487-
EC-GC-1, SPCS31.02068757-
EC-GC-1, ENSG000002506461.917331079-
EC-GC-1, ENSG000002581681.083991656-
EC-GC-1, ST8SIA40.901071433-
EC-GC-1, BCL2L1-AS11.262413164-
EC-GC-1, NRSN2-AS1-1.275348201-
EC-GC-1, STARD13-AS1.148054491-
EC-GC-1, CFLAR-AS11.168941896-
EC-GC-1, PRKAR1A1.257792414-
EC-GC-1, ENSG000002262391.126077043-
EC-GC-1, CTNNA3-1.819759686-
EC-GC-1, KCNK5-2.491597199-
EC-GC-1, ESR21.071576206-
EC-GC-1, SLC25A461.062235788-
EC-GC-1, REV3L0.792446528-
EC-GC-1, ZC2HC1C2.027909336-
EC-GC-1, ENSG00000279686-1.453758633-
EC-GC-1, ACER1-5.256214457-
EC-GC-1, MALRD1-2.36001857-
EC-GC-1, RRBP1-0.837125744-
EC-GC-1, ZNF451-AS11.853753635-
EC-GC-1, SHANK2-1.481833304-
EC-GC-1, ENSG000002483882.196067138-
EC-GC-1, KPNA50.936135624-
EC-GC-1, APPAT-1.750949862-
EC-GC-1, PCNT-0.932423432-
EC-GC-1, ENSG000002338482.752498803-
EC-GC-1, MORF4L21.28059543-
EC-GC-1, ENSG00000236283-1.572597604-
EC-GC-1, SNRNP70-0.883484114-
EC-GC-1, EXD3-0.805539835-
EC-GC-1, CNTNAP5-2.392758482-
EC-GC-1, CASR-2.323412555-
EC-GC-1, ENSG000002856921.124516569-
EC-GC-1, WDR81-2.102548546-
EC-GC-1, ZNF160-0.907890266-
EC-GC-1, CA12-1.63720477-
EC-GC-1, MAPK8IP3-0.998528168-
EC-GC-1, ABTB3-2.945080572-
EC-GC-1, CHORDC11.047593755-
EC-GC-1, FREM1-1.948982139-
EC-GC-1, FXYD6-AS12.22442108-
EC-GC-1, SPACA6-1.045439073-
EC-GC-1, AGBL1-2.851170905-
EC-GC-2, NES-2.451444521-
EC-GC-2, ADARB2-3.212266234-
EC-GC-2, SERPINB92.315559798-
EC-GC-2, ENSG00000274422-2.329265154-
EC-GC-2, BTNL9-2.01168798-
EC-GC-2, CPEB21.51543417-
EC-GC-2, TBX2-2.604511077-
EC-GC-2, ENSG000002905602.378813977-
EC-GC-2, CFAP541.988387042-
EC-GC-2, ABI3BP1.57362138-
EC-GC-2, SPACA6-1.724379529-
EC-GC-2, ADAMTSL2-2.009897896-
EC-GC-2, LZTS1-2.659531511-
EC-GC-2, ENSG000002857441.889210245-
EC-GC-2, ENSG00000225689-1.414674941-
EC-GC-2, LUZP2-4.384000321-
EC-GC-2, NCKAP5-1.592351284-
EC-GC-2, FAT1-1.855192898-
NKC-NKT, AGBL4-2.145446805-
NKC-NKT, TFEC1.989578132-
NKC-NKT, ENSG00000254186-2.913048038-
NKC-NKT, PDE10A-2.170777761-
NKC-NKT, SHANK2-2.431773845-
PEC, RGS6-3.331377896-
PEC, AHNAK-1.645129407-
PT-2, LRRC4C-2.167101922-
PT-2, DSCAM-3.104786855-
PT-2, RCN3-1.636040003-
Secondary/registry result/low confidence

Change in Mean Arterial Flow (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

ratio, descriptive

Posted result

GroupGeometric mean · Ratio of mean arterial flow95% CI
Semaglutide 1.0 mgBilateral renalartery0.96-
Right renalartery0.97-
Left renalartery0.96-
PlaceboBilateral renalartery0.96-
Right renalartery0.95-
Left renalartery0.98-
Secondary/registry result/low confidence

Change in Natriuresis (Urinary Sodium Excretion) (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Posted result

GroupMean · Millimoles per day (mmol/day)95% CI
Semaglutide 1.0 mg-7.3-
Placebo-26.9-
Secondary/protocol endpoint/low confidence

Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Mean Arterial Flow (MRI)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Natriuresis (Urinary Sodium Excretion) (Urinalysis)

Time frame:Baseline (week 0), End of treatment (week 52)

change from baseline, descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.