← Trials/Trial dossier/NCT04865770

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

Enrollment

106

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

eGFR ≥30UACR ≥20

Primary endpoints

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

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

GroupValue (geometric_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% CI0.961.01p0.1333ANCOVA

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% CI0.961.01p0.2487ANCOVA

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% CI0.941.00p0.0907ANCOVA

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

GroupValue (geometric_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% CI0.941.03p0.5619ANCOVA

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% CI0.931.02p0.2774ANCOVA

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% CI0.941.04p0.7924ANCOVA

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

GroupValue (geometric_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% CI0.981.24p0.0958ANCOVA

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% CI1.031.33p0.0145ANCOVA

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% CI0.941.21p0.3311ANCOVA

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

GroupValue (geometric_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% CI0.981.02p0.8651ANCOVA

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% CI0.981.02p0.7240ANCOVA

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% CI0.981.02p0.7195ANCOVA

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

GroupValue (geometric_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% CI0.981.02p0.9335ANCOVA

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% CI0.981.01p0.6517ANCOVA

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% CI0.981.02p0.9017ANCOVA

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

GroupValue (mean), 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

GroupValue (geometric_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

GroupValue (geometric_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

GroupValue (geometric_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

GroupValue (mean), 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

GroupValue (mean), 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

GroupValue (number), 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

GroupValue (geometric_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

GroupValue (mean), 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 1, 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 1, 2026 snapshot.