Trial Outcomes & Findings for 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) (NCT NCT04865770)
NCT ID: NCT04865770
Last Updated: 2026-01-14
Results Overview
Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2\* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2\* value means lower tissue oxygenation while a lower R2\* value means higher tissue oxygenation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
Baseline (week 0), End of treatment (week 52)
Results posted on
2026-01-14
Participant Flow
The trial was conducted at 31 sites in 8 countries.
Participants were randomized in a 2:1 ratio to receive semaglutide or placebo, respectively. Both added to standard-of-care treatment.
Participant milestones
| Measure |
Semaglutide 1.0 mg
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
Placebo
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
35
|
|
Overall Study
Full Analysis Set
|
71
|
35
|
|
Overall Study
Safety Analysis Set
|
71
|
35
|
|
Overall Study
COMPLETED
|
58
|
34
|
|
Overall Study
NOT COMPLETED
|
13
|
1
|
Reasons for withdrawal
| Measure |
Semaglutide 1.0 mg
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
Placebo
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
9
|
0
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.2 • n=14 Participants
|
65.1 Years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
65.3 Years
STANDARD_DEVIATION 9.9 • n=24 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=14 Participants
|
9 Participants
n=10 Participants
|
25 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=14 Participants
|
26 Participants
n=10 Participants
|
81 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=14 Participants
|
28 Participants
n=10 Participants
|
87 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
2 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
5 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
6 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=14 Participants
|
22 Participants
n=10 Participants
|
65 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
15 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2\* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2\* value means lower tissue oxygenation while a lower R2\* value means higher tissue oxygenation.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)
Bilateral cortex
|
1.00 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 7.39
|
0.98 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 5.35
|
|
Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)
Right cortex
|
0.99 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 7.26
|
0.98 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 5.65
|
|
Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)
Left cortex
|
1.01 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 9.12
|
0.98 Ratio of kidney oxygenation (cortex)
Geometric Coefficient of Variation 7.51
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in kidney oxygenation in medulla assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2\* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2\* value means lower tissue oxygenation while a lower R2\* value means higher tissue oxygenation.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
Bilateral medulla
|
1.01 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 11.37
|
0.99 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 8.97
|
|
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
Right medulla
|
1.02 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 10.83
|
0.98 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 10.09
|
|
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)
Left medulla
|
1.02 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 13.02
|
0.99 Ratio of kidney oxygenation (medulla)
Geometric Coefficient of Variation 10.25
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in global kidney perfusion assessed by phase contrast MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Global Kidney Perfusion (MRI)
Left kidney
|
1.01 Ratio of global kidney perfusion
Geometric Coefficient of Variation 26.83
|
1.02 Ratio of global kidney perfusion
Geometric Coefficient of Variation 29.25
|
|
Change in Global Kidney Perfusion (MRI)
Bilateral kidney
|
0.99 Ratio of global kidney perfusion
Geometric Coefficient of Variation 24.39
|
1.03 Ratio of global kidney perfusion
Geometric Coefficient of Variation 26.43
|
|
Change in Global Kidney Perfusion (MRI)
Right kidney
|
0.98 Ratio of global kidney perfusion
Geometric Coefficient of Variation 28.85
|
1.04 Ratio of global kidney perfusion
Geometric Coefficient of Variation 27.84
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in kidney inflammation in cortex assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)
Right cortex
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 5.57
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 3.88
|
|
Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)
Left cortex
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 5.71
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 3.93
|
|
Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)
Bilateral cortex
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 5.43
|
1.01 Ratio of kidney inflammation (cortex)
Geometric Coefficient of Variation 3.78
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in kidney inflammation in medulla assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)
Bilateral medulla
|
1.00 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 5.13
|
1.00 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 3.56
|
|
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)
Right medulla
|
1.01 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 4.85
|
1.00 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 3.90
|
|
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)
Left medulla
|
1.00 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 5.91
|
1.00 Ratio of kidney inflammation (medulla)
Geometric Coefficient of Variation 3.69
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.
Changes in gene expression were assessed by single nucleus RNA sequencing (kidney biopsies) from baseline (week 0) to end of treatment (week 52). Cell type annotation was performed prior to the analysis. The analysis reports the log2 fold change in form of differential gene expression per cell type from baseline, comparing treatment arms. Genes are considered significant if fold change \> 0.5 or \< 0.5 and false discovery rate (FDR) \<0.1; these criteria help identify biologically significant genes that are reliably differentially expressed in patients with conditions such as Type 2 diabetes and chronic kidney disease. The differential expression was estimated using a linear mixed model that included participant as a random effect. The cell types presented are those that contain these differentially expressed genes demonstrating the treatment response. This threshold is based on findings published in cross-sectional observational studies related to disease impact and gene activity.
Outcome measures
| Measure |
Placebo
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=22 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
CNT-2, RSPO3
|
—
|
3.468216523 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
CNT-Immune, SLC8A1-AS1
|
—
|
2.8531071 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, KCNK6
|
—
|
-1.952545192 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, EMC10
|
—
|
-2.485824696 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000286145
|
—
|
1.831300888 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LMF1
|
—
|
-1.528463786 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ANKUB1
|
—
|
1.783402404 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, AHNAK
|
—
|
-1.368952211 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000286150
|
—
|
1.318309657 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, NSUN6
|
—
|
-1.464540152 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, TFCP2L1
|
—
|
-2.24516792 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000274422
|
—
|
-1.860725608 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, DPYD-AS1
|
—
|
1.996950045 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000248138
|
—
|
2.110414741 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ACSM2B
|
—
|
-1.785467699 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CCNH
|
—
|
1.033873239 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, QTRT1
|
—
|
-2.415240141 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CROCCP3
|
—
|
-1.254541813 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000251034
|
—
|
1.750285729 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LSAMP
|
—
|
-2.439268964 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LHX1-DT
|
—
|
-4.256689925 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ESRRG
|
—
|
-1.527414037 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CNTNAP2
|
—
|
-2.377391827 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000284966
|
—
|
1.665764749 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, BICC1
|
—
|
-1.445239386 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, GNA14-AS1
|
—
|
1.192645521 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, GUSBP11
|
—
|
-1.318511642 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000233783
|
—
|
1.668536087 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SEMA6A-AS1
|
—
|
1.183886707 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, RBMS3-AS2
|
—
|
1.572052032 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000286147
|
—
|
-4.468841041 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LINC00342
|
—
|
-1.151143461 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, IRF3
|
—
|
-1.566408786 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000249207
|
—
|
1.35685803 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CRADD-AS1
|
—
|
1.972404772 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, TOX3
|
—
|
-2.206055055 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000286458
|
—
|
1.271036656 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SLC12A3
|
—
|
-2.531722898 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, TALAM1
|
—
|
1.235573321 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PCDH17
|
—
|
1.107442597 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ATP13A3
|
—
|
1.078246118 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000231772
|
—
|
-2.382264501 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, FBXL19
|
—
|
-2.166973377 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000254420
|
—
|
1.74612131 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SPC25
|
—
|
1.329461228 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SMAD4
|
—
|
1.13655744 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, UFM1
|
—
|
1.20264148 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000259564
|
—
|
2.071724947 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SHOC1
|
—
|
1.634369451 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, MEF2C-AS2
|
—
|
1.753288691 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000285801
|
—
|
1.440844025 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, FAM228B
|
—
|
-1.22996414 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, GLS
|
—
|
0.868999317 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, GDPD4
|
—
|
-6.564026305 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, INSYN2A
|
—
|
1.759769032 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, TNFRSF14
|
—
|
-1.254004029 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PRX
|
—
|
-1.199880651 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PNN
|
—
|
-1.024604708 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, KCNQ1OT1
|
—
|
-0.794847103 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ACAP3
|
—
|
-1.44397269 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, BASP1-AS1
|
—
|
-4.83539932 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, RBFOX1
|
—
|
-1.706411849 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CCDC90B-AS1
|
—
|
-1.678217382 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000240499
|
—
|
1.514399208 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LINC03076
|
—
|
1.545248095 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, LINC01409
|
—
|
-1.022992954 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CCT4
|
—
|
1.455396063 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CDC73
|
—
|
0.802691458 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, NUMA1
|
—
|
-0.931923316 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, FLT4
|
—
|
-0.935590968 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PDLIM5
|
—
|
0.764926487 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SPCS3
|
—
|
1.02068757 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000250646
|
—
|
1.917331079 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000258168
|
—
|
1.083991656 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ST8SIA4
|
—
|
0.901071433 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, BCL2L1-AS1
|
—
|
1.262413164 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, NRSN2-AS1
|
—
|
-1.275348201 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, STARD13-AS
|
—
|
1.148054491 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CFLAR-AS1
|
—
|
1.168941896 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PRKAR1A
|
—
|
1.257792414 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000226239
|
—
|
1.126077043 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CTNNA3
|
—
|
-1.819759686 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, KCNK5
|
—
|
-2.491597199 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ESR2
|
—
|
1.071576206 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SLC25A46
|
—
|
1.062235788 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, REV3L
|
—
|
0.792446528 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ZC2HC1C
|
—
|
2.027909336 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000279686
|
—
|
-1.453758633 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ACER1
|
—
|
-5.256214457 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, MALRD1
|
—
|
-2.36001857 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, RRBP1
|
—
|
-0.837125744 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ZNF451-AS1
|
—
|
1.853753635 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SHANK2
|
—
|
-1.481833304 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000248388
|
—
|
2.196067138 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, KPNA5
|
—
|
0.936135624 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, APPAT
|
—
|
-1.750949862 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, PCNT
|
—
|
-0.932423432 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000233848
|
—
|
2.752498803 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, MORF4L2
|
—
|
1.28059543 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000236283
|
—
|
-1.572597604 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SNRNP70
|
—
|
-0.883484114 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, EXD3
|
—
|
-0.805539835 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CNTNAP5
|
—
|
-2.392758482 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CASR
|
—
|
-2.323412555 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ENSG00000285692
|
—
|
1.124516569 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, WDR81
|
—
|
-2.102548546 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ZNF160
|
—
|
-0.907890266 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CA12
|
—
|
-1.63720477 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, MAPK8IP3
|
—
|
-0.998528168 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, ABTB3
|
—
|
-2.945080572 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, CHORDC1
|
—
|
1.047593755 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, FREM1
|
—
|
-1.948982139 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, FXYD6-AS1
|
—
|
2.22442108 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, SPACA6
|
—
|
-1.045439073 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-1, AGBL1
|
—
|
-2.851170905 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, NES
|
—
|
-2.451444521 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ADARB2
|
—
|
-3.212266234 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, SERPINB9
|
—
|
2.315559798 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ENSG00000274422
|
—
|
-2.329265154 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, BTNL9
|
—
|
-2.01168798 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, CPEB2
|
—
|
1.51543417 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, TBX2
|
—
|
-2.604511077 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ENSG00000290560
|
—
|
2.378813977 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, CFAP54
|
—
|
1.988387042 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ABI3BP
|
—
|
1.57362138 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, SPACA6
|
—
|
-1.724379529 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ADAMTSL2
|
—
|
-2.009897896 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, LZTS1
|
—
|
-2.659531511 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ENSG00000285744
|
—
|
1.889210245 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, ENSG00000225689
|
—
|
-1.414674941 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, LUZP2
|
—
|
-4.384000321 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, NCKAP5
|
—
|
-1.592351284 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
EC-GC-2, FAT1
|
—
|
-1.855192898 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
NKC-NKT, AGBL4
|
—
|
-2.145446805 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
NKC-NKT, TFEC
|
—
|
1.989578132 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
NKC-NKT, ENSG00000254186
|
—
|
-2.913048038 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
NKC-NKT, PDE10A
|
—
|
-2.170777761 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
NKC-NKT, SHANK2
|
—
|
-2.431773845 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
PEC, RGS6
|
—
|
-3.331377896 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
PEC, AHNAK
|
—
|
-1.645129407 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
PT-2, LRRC4C
|
—
|
-2.167101922 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
PT-2, DSCAM
|
—
|
-3.104786855 log2 fold-change
|
|
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)
PT-2, RCN3
|
—
|
-1.636040003 log2 fold-change
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.
Change in glomerular basement membrane width assessed in kidney biopsy from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=12 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Glomerular Basement Membrane Width (Kidney Biopsy)
|
-8.66 Nanometer (nm)
Standard Deviation 206.35
|
-72.67 Nanometer (nm)
Standard Deviation 96.60
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in apparent diffusion coefficient in cortex assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)
Right cortex
|
0.93 Ratio of ADC (cortex)
Geometric Coefficient of Variation 12.12
|
0.98 Ratio of ADC (cortex)
Geometric Coefficient of Variation 6.70
|
|
Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)
Bilateral cortex
|
0.94 Ratio of ADC (cortex)
Geometric Coefficient of Variation 11.40
|
1.00 Ratio of ADC (cortex)
Geometric Coefficient of Variation 6.56
|
|
Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)
Left cortex
|
0.96 Ratio of ADC (cortex)
Geometric Coefficient of Variation 10.48
|
1.01 Ratio of ADC (cortex)
Geometric Coefficient of Variation 8.50
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in apparent diffusion coefficient in medulla assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)
Bilateral medulla
|
0.94 Ratio of ADC (medulla)
Geometric Coefficient of Variation 13.51
|
0.98 Ratio of ADC (medulla)
Geometric Coefficient of Variation 8.90
|
|
Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)
Left medulla
|
0.95 Ratio of ADC (medulla)
Geometric Coefficient of Variation 13.41
|
0.99 Ratio of ADC (medulla)
Geometric Coefficient of Variation 9.51
|
|
Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)
Right medulla
|
0.93 Ratio of ADC (medulla)
Geometric Coefficient of Variation 13.94
|
0.98 Ratio of ADC (medulla)
Geometric Coefficient of Variation 10.00
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in renal arterial resistive index assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. RARI measures the preservation of blood flow in renal arteries throughout the cardiac cycle and is therefore a measure for resistance of blood flow within the renal arteries. It serves as an indicator of kidney vascular health and potential arterial stiffness or obstruction. It is prognostic for primary cardiovascular and renal events in type 2 diabetes, where a lower RARI predicts a lower rate of events. RARI is calculated by relating the difference between blood flow at maximum velocity during the cardiac contraction phase (peak systolic velocity, PSV) and the speed at the end of the relaxation phase, at the point of minimal velocity (end diastolic velocity, EDV) with PSV, i.e., RARI = (PSV-EDV)/PSV.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Mean Renal Artery Resistive Index (RARI) (MRI)
Bilateral renalartery
|
1.01 Ratio of RARI
Geometric Coefficient of Variation 6.13
|
0.97 Ratio of RARI
Geometric Coefficient of Variation 7.00
|
|
Change in Mean Renal Artery Resistive Index (RARI) (MRI)
Right renalartery
|
1.01 Ratio of RARI
Geometric Coefficient of Variation 8.62
|
0.98 Ratio of RARI
Geometric Coefficient of Variation 8.38
|
|
Change in Mean Renal Artery Resistive Index (RARI) (MRI)
Left renalartery
|
1.01 Ratio of RARI
Geometric Coefficient of Variation 6.43
|
0.97 Ratio of RARI
Geometric Coefficient of Variation 7.44
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.
Change in mean arterial flow assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=71 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Mean Arterial Flow (MRI)
Left renalartery
|
0.98 Ratio of mean arterial flow
Geometric Coefficient of Variation 27.38
|
0.96 Ratio of mean arterial flow
Geometric Coefficient of Variation 25.06
|
|
Change in Mean Arterial Flow (MRI)
Bilateral renalartery
|
0.96 Ratio of mean arterial flow
Geometric Coefficient of Variation 25.06
|
0.96 Ratio of mean arterial flow
Geometric Coefficient of Variation 24.96
|
|
Change in Mean Arterial Flow (MRI)
Right renalartery
|
0.95 Ratio of mean arterial flow
Geometric Coefficient of Variation 29.09
|
0.97 Ratio of mean arterial flow
Geometric Coefficient of Variation 30.21
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.
Change in natriuresis (urinary sodium excretion) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=57 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Natriuresis (Urinary Sodium Excretion) (Urinalysis)
|
-26.9 Millimoles per day (mmol/day)
Standard Deviation 85.2
|
-7.3 Millimoles per day (mmol/day)
Standard Deviation 71.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.
Change in albumin excretion rate (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=56 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Albumin Excretion Rate (Urinalysis)
|
-233.2 Milligrams per day (mg/d)
Standard Deviation 964.8
|
-81.9 Milligrams per day (mg/d)
Standard Deviation 708.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 52)Population: Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.
Change in kidney function (creatinine clearance) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
Semaglutide 1.0 mg
n=53 Participants
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
|---|---|---|
|
Change in Kidney Function (Creatinine Clearance) (Urinalysis)
|
-12.6 Milliliter per minute
Standard Deviation 34.2
|
3.8 Milliliter per minute
Standard Deviation 26.6
|
Adverse Events
Semaglutide 1.0 mg
Serious events: 14 serious events
Other events: 15 other events
Deaths: 2 deaths
Placebo
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Semaglutide 1.0 mg
n=71 participants at risk
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
Placebo
n=35 participants at risk
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
4/71 • Number of events 4 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Psychiatric disorders
Anger
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
General disorders
Death
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
2.9%
1/35 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Renal and urinary disorders
End stage renal disease
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
2.9%
1/35 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Infections and infestations
Osteomyelitis
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
2.9%
1/35 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Vascular disorders
Peripheral vascular disorder
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
2.9%
1/35 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Psychiatric disorders
Suicide attempt
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
2.9%
1/35 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
Other adverse events
| Measure |
Semaglutide 1.0 mg
n=71 participants at risk
Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
|
Placebo
n=35 participants at risk
Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
5.6%
4/71 • Number of events 4 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
4/71 • Number of events 4 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
0.00%
0/35 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Eye disorders
Diabetic retinopathy
|
5.6%
4/71 • Number of events 4 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
5.7%
2/35 • Number of events 2 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
4/71 • Number of events 4 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
11.4%
4/35 • Number of events 5 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
5.7%
2/35 • Number of events 2 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
4/71 • Number of events 5 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
5.7%
2/35 • Number of events 2 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/71 • Number of events 1 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
5.7%
2/35 • Number of events 2 • Up to week 57
Safety analysis set- all participants randomly assigned to trial treatment \& who take at least 1 dose of trial product. All presented AEs are treatment emergent adverse events (TEAEs). A TEAE was defined as an AE with onset in all observed data points from first date of study product until permanent discontinuation of treatment. A participant died after discontinuing study by physician decision hence was counted in 'physician decision' category in 'Participant Flow' in semaglutide arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER