← Trials/Trial dossier/NCT04865770
REMODEL
CompletedPhase 3Results postedA 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
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 ≥30•UACR ≥20
Primary endpoints
•Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic•Kidney 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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).
Exclusion criteria
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 endpointsChange 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
| Group | Value (geometric_mean), Ratio of kidney oxygenation (cortex) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral cortex | 0.98 | — |
| Right cortex | 0.98 | — |
| Left cortex | 0.98 | — |
| PlaceboBilateral cortex | 1.00 | — |
| Right cortex | 0.99 | — |
| Left cortex | 1.01 | — |
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.
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.
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.
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of kidney oxygenation (medulla) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral medulla | 0.99 | — |
| Right medulla | 0.98 | — |
| Left medulla | 0.99 | — |
| PlaceboBilateral medulla | 1.01 | — |
| Right medulla | 1.02 | — |
| Left medulla | 1.02 | — |
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.
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.
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.
Change in Global Kidney Perfusion (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of global kidney perfusion | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral kidney | 1.03 | — |
| Right kidney | 1.04 | — |
| Left kidney | 1.02 | — |
| PlaceboBilateral kidney | 0.99 | — |
| Right kidney | 0.98 | — |
| Left kidney | 1.01 | — |
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.
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.
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.
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
| Group | Value (geometric_mean), Ratio of kidney inflammation (cortex) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral cortex | 1.01 | — |
| Right cortex | 1.01 | — |
| Left cortex | 1.01 | — |
| PlaceboBilateral cortex | 1.01 | — |
| Right cortex | 1.01 | — |
| Left cortex | 1.01 | — |
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.
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.
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.
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of kidney inflammation (medulla) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral medulla | 1.00 | — |
| Right medulla | 1.00 | — |
| Left medulla | 1.00 | — |
| PlaceboBilateral medulla | 1.00 | — |
| Right medulla | 1.01 | — |
| Left medulla | 1.00 | — |
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.
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.
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.
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
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Global Kidney Perfusion (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
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
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Glomerular Basement Membrane Width (Kidney Biopsy)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (mean), Nanometer (nm) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -72.67 | — |
| Placebo | -8.66 | — |
Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of ADC (cortex) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral cortex | 1.00 | — |
| Left cortex | 1.01 | — |
| Right cortex | 0.98 | — |
| PlaceboBilateral cortex | 0.94 | — |
| Left cortex | 0.96 | — |
| Right cortex | 0.93 | — |
Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of ADC (medulla) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral medulla | 0.98 | — |
| Left medulla | 0.99 | — |
| Right medulla | 0.98 | — |
| PlaceboBilateral medulla | 0.94 | — |
| Left medulla | 0.95 | — |
| Right medulla | 0.93 | — |
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
| Group | Value (geometric_mean), Ratio of RARI | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral renalartery | 0.97 | — |
| Right renalartery | 0.98 | — |
| Left renalartery | 0.97 | — |
| PlaceboBilateral renalartery | 1.01 | — |
| Right renalartery | 1.01 | — |
| Left renalartery | 1.01 | — |
Change in Albumin Excretion Rate (Urinalysis)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (mean), Milligrams per day (mg/d) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -81.9 | — |
| Placebo | -233.2 | — |
Change in Kidney Function (Creatinine Clearance) (Urinalysis)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Posted result
| Group | Value (mean), Milliliter per minute | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | 3.8 | — |
| Placebo | -12.6 | — |
Change in Glomerular Basement Membrane Width (Kidney Biopsy)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, descriptive
Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Mean Renal Artery Resistive Index (RARI) (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Albumin Excretion Rate (Urinalysis)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Change in Kidney Function (Creatinine Clearance) (Urinalysis)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, improvement
Other (unclassified)
6 endpointsChange 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
| Group | Value (number), log2 fold-change | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg/PlaceboCNT-2, RSPO3 | 3.468216523 | — |
| CNT-Immune, SLC8A1-AS1 | 2.8531071 | — |
| EC-GC-1, KCNK6 | -1.952545192 | — |
| EC-GC-1, EMC10 | -2.485824696 | — |
| EC-GC-1, ENSG00000286145 | 1.831300888 | — |
| EC-GC-1, LMF1 | -1.528463786 | — |
| EC-GC-1, ANKUB1 | 1.783402404 | — |
| EC-GC-1, AHNAK | -1.368952211 | — |
| EC-GC-1, ENSG00000286150 | 1.318309657 | — |
| EC-GC-1, NSUN6 | -1.464540152 | — |
| EC-GC-1, TFCP2L1 | -2.24516792 | — |
| EC-GC-1, ENSG00000274422 | -1.860725608 | — |
| EC-GC-1, DPYD-AS1 | 1.996950045 | — |
| EC-GC-1, ENSG00000248138 | 2.110414741 | — |
| EC-GC-1, ACSM2B | -1.785467699 | — |
| EC-GC-1, CCNH | 1.033873239 | — |
| EC-GC-1, QTRT1 | -2.415240141 | — |
| EC-GC-1, CROCCP3 | -1.254541813 | — |
| EC-GC-1, ENSG00000251034 | 1.750285729 | — |
| 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, ENSG00000284966 | 1.665764749 | — |
| EC-GC-1, BICC1 | -1.445239386 | — |
| EC-GC-1, GNA14-AS1 | 1.192645521 | — |
| EC-GC-1, GUSBP11 | -1.318511642 | — |
| EC-GC-1, ENSG00000233783 | 1.668536087 | — |
| EC-GC-1, SEMA6A-AS1 | 1.183886707 | — |
| EC-GC-1, RBMS3-AS2 | 1.572052032 | — |
| EC-GC-1, ENSG00000286147 | -4.468841041 | — |
| EC-GC-1, LINC00342 | -1.151143461 | — |
| EC-GC-1, IRF3 | -1.566408786 | — |
| EC-GC-1, ENSG00000249207 | 1.35685803 | — |
| EC-GC-1, CRADD-AS1 | 1.972404772 | — |
| EC-GC-1, TOX3 | -2.206055055 | — |
| EC-GC-1, ENSG00000286458 | 1.271036656 | — |
| EC-GC-1, SLC12A3 | -2.531722898 | — |
| EC-GC-1, TALAM1 | 1.235573321 | — |
| EC-GC-1, PCDH17 | 1.107442597 | — |
| EC-GC-1, ATP13A3 | 1.078246118 | — |
| EC-GC-1, ENSG00000231772 | -2.382264501 | — |
| EC-GC-1, FBXL19 | -2.166973377 | — |
| EC-GC-1, ENSG00000254420 | 1.74612131 | — |
| EC-GC-1, SPC25 | 1.329461228 | — |
| EC-GC-1, SMAD4 | 1.13655744 | — |
| EC-GC-1, UFM1 | 1.20264148 | — |
| EC-GC-1, ENSG00000259564 | 2.071724947 | — |
| EC-GC-1, SHOC1 | 1.634369451 | — |
| EC-GC-1, MEF2C-AS2 | 1.753288691 | — |
| EC-GC-1, ENSG00000285801 | 1.440844025 | — |
| EC-GC-1, FAM228B | -1.22996414 | — |
| EC-GC-1, GLS | 0.868999317 | — |
| EC-GC-1, GDPD4 | -6.564026305 | — |
| EC-GC-1, INSYN2A | 1.759769032 | — |
| 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, ENSG00000240499 | 1.514399208 | — |
| EC-GC-1, LINC03076 | 1.545248095 | — |
| EC-GC-1, LINC01409 | -1.022992954 | — |
| EC-GC-1, CCT4 | 1.455396063 | — |
| EC-GC-1, CDC73 | 0.802691458 | — |
| EC-GC-1, NUMA1 | -0.931923316 | — |
| EC-GC-1, FLT4 | -0.935590968 | — |
| EC-GC-1, PDLIM5 | 0.764926487 | — |
| EC-GC-1, SPCS3 | 1.02068757 | — |
| EC-GC-1, ENSG00000250646 | 1.917331079 | — |
| EC-GC-1, ENSG00000258168 | 1.083991656 | — |
| EC-GC-1, ST8SIA4 | 0.901071433 | — |
| EC-GC-1, BCL2L1-AS1 | 1.262413164 | — |
| EC-GC-1, NRSN2-AS1 | -1.275348201 | — |
| EC-GC-1, STARD13-AS | 1.148054491 | — |
| EC-GC-1, CFLAR-AS1 | 1.168941896 | — |
| EC-GC-1, PRKAR1A | 1.257792414 | — |
| EC-GC-1, ENSG00000226239 | 1.126077043 | — |
| EC-GC-1, CTNNA3 | -1.819759686 | — |
| EC-GC-1, KCNK5 | -2.491597199 | — |
| EC-GC-1, ESR2 | 1.071576206 | — |
| EC-GC-1, SLC25A46 | 1.062235788 | — |
| EC-GC-1, REV3L | 0.792446528 | — |
| EC-GC-1, ZC2HC1C | 2.027909336 | — |
| 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-AS1 | 1.853753635 | — |
| EC-GC-1, SHANK2 | -1.481833304 | — |
| EC-GC-1, ENSG00000248388 | 2.196067138 | — |
| EC-GC-1, KPNA5 | 0.936135624 | — |
| EC-GC-1, APPAT | -1.750949862 | — |
| EC-GC-1, PCNT | -0.932423432 | — |
| EC-GC-1, ENSG00000233848 | 2.752498803 | — |
| EC-GC-1, MORF4L2 | 1.28059543 | — |
| 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, ENSG00000285692 | 1.124516569 | — |
| 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, CHORDC1 | 1.047593755 | — |
| EC-GC-1, FREM1 | -1.948982139 | — |
| EC-GC-1, FXYD6-AS1 | 2.22442108 | — |
| 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, SERPINB9 | 2.315559798 | — |
| EC-GC-2, ENSG00000274422 | -2.329265154 | — |
| EC-GC-2, BTNL9 | -2.01168798 | — |
| EC-GC-2, CPEB2 | 1.51543417 | — |
| EC-GC-2, TBX2 | -2.604511077 | — |
| EC-GC-2, ENSG00000290560 | 2.378813977 | — |
| EC-GC-2, CFAP54 | 1.988387042 | — |
| EC-GC-2, ABI3BP | 1.57362138 | — |
| EC-GC-2, SPACA6 | -1.724379529 | — |
| EC-GC-2, ADAMTSL2 | -2.009897896 | — |
| EC-GC-2, LZTS1 | -2.659531511 | — |
| EC-GC-2, ENSG00000285744 | 1.889210245 | — |
| 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, TFEC | 1.989578132 | — |
| 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 | — |
Change in Mean Arterial Flow (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of mean arterial flow | 95% CI |
|---|---|---|
| Semaglutide 1.0 mgBilateral renalartery | 0.96 | — |
| Right renalartery | 0.97 | — |
| Left renalartery | 0.96 | — |
| PlaceboBilateral renalartery | 0.96 | — |
| Right renalartery | 0.95 | — |
| Left renalartery | 0.98 | — |
Change in Natriuresis (Urinary Sodium Excretion) (Urinalysis)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, descriptive
Posted result
| Group | Value (mean), Millimoles per day (mmol/day) | 95% CI |
|---|---|---|
| Semaglutide 1.0 mg | -7.3 | — |
| Placebo | -26.9 | — |
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
Change in Mean Arterial Flow (MRI)
Time frame:Baseline (week 0), End of treatment (week 52)
change from baseline, descriptive
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
- Kidney international2026 Jan (month)PMID41207620doi:10.1016/j.kint.2025.10.005via clinicaltrials gov reference derived + pubmed nct search
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2025 Oct 30PMID40608494doi:10.1093/ndt/gfaf114via pubmed nct search
- The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
- Clinical journal of the American Society of Nephrology : CJASN2025 Feb 1PMID39480988doi:10.2215/CJN.0000000584via clinicaltrials gov reference derived + pubmed nct search
- American journal of preventive cardiology2023 Jun (month)PMID37313358doi:10.1016/j.ajpc.2023.100502via pubmed nct search
Provenance
Sources
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.