Trial Outcomes & Findings for Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan. (NCT NCT04626505)

Last Updated: 2026-05-06

Results Overview

Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Baseline (day 1), end of treatment (average of week 10 and week 12)

Results posted on

2026-05-06

Participant Flow

The trial was conducted in Japan and included 12 sites that were initiated, 11 sites that screened study participants, and 10 sites that enrolled study participants.

Participants were randomized 1:1:1 to ziltivekimab 15 milligrams (mg), ziltivekimab 30 mg, or placebo groups for a 12-week treatment period. Participants were followed for safety from week 12 to week 20.

Participant milestones

Participant milestones
Measure	Placebo Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.	Ziltivekimab 15 mg Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.
Overall Study STARTED	13	11	12
Overall Study Treated	12	11	12
Overall Study Intent-to-Treat (ITT) Population	13	11	12
Overall Study Safety Population	12	11	12
Overall Study COMPLETED	12	11	12
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.	Ziltivekimab 15 mg Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Total n=36 Participants Total of all reporting groups
Age, Continuous	63.6 Years STANDARD_DEVIATION 12.01 • n=54 Participants	66.2 Years STANDARD_DEVIATION 10.26 • n=60 Participants	61.4 Years STANDARD_DEVIATION 15.09 • n=114 Participants	63.7 Years STANDARD_DEVIATION 12.44 • n=480 Participants
Sex: Female, Male Female	5 Participants n=54 Participants	4 Participants n=60 Participants	3 Participants n=114 Participants	12 Participants n=480 Participants
Sex: Female, Male Male	8 Participants n=54 Participants	7 Participants n=60 Participants	9 Participants n=114 Participants	24 Participants n=480 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=54 Participants	11 Participants n=60 Participants	12 Participants n=114 Participants	36 Participants n=480 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Asian	13 Participants n=54 Participants	11 Participants n=60 Participants	12 Participants n=114 Participants	36 Participants n=480 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) White	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=480 Participants

PRIMARY outcome

Timeframe: Baseline (day 1), end of treatment (average of week 10 and week 12)

Population: The Intent-to-Treat (ITT) Population was defined as all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) Levels From Baseline (Average of All Hs-CRP Values Prior to the Administration of Study Drug) to the End of Treatment (Average of Week 10 and Week 12)	-96.23 Percent change Interval -98.89 to -91.67	-93.41 Percent change Interval -96.59 to -88.34	-27.01 Percent change Interval -46.71 to -3.83

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

An adverse event (AE) was any undesirable event or any untoward medical occurrence that occurred in a participant during the course of the study or the protocol-defined time after study termination, whether or not that event was considered study drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). Number of TEAEs from randomization (day 1) to week 20 are presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Number of Treatment-emergent Adverse Events (TEAEs)	41 Events	16 Events	25 Events

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

An AE was any undesirable event or any untoward medical occurrence that occurred in a participant during the course of the study or the protocol-defined time after study termination, whether or not that event was considered study drug-related. An SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. ). Number of SAEs from randomization (day 1) to week 20 are presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Number of Serious Adverse Events (SAEs)	5 Events	0 Events	2 Events

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Number of participants with vital signs parameters (including systolic blood pressure, heart rate and respiratory rate) exceeding pre-defined criteria are presented. The pre-defined criteria were: 1) systolic blood pressure: greater than (\>25) millimeters of mercury (mmHg) increase or decrease from baseline and \>160 mmHg; 2) heart rate: \>100 beats per minute; 3)respiratory rate: \>24 breaths per minute.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria Systolic Blood Pressure: >25 mmHg increase or decrease from baseline	3 Participants	4 Participants	5 Participants
Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria Systolic Blood Pressure: >160 mmHg	2 Participants	0 Participants	2 Participants
Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria Respiratory Rate: >24 breaths per minute	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria Heart Rate: >100 beats per minute	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

The ECG was assessed by the investigator at baseline (Day 1) and week 20 and categorised as abnormal clinically significant, abnormal not clinically significant, indeterminate, normal, not evaluable and unknown. Number of participants in each ECG category at baseline and week 20 are presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change in Electrocardiogram (ECG) Baseline (Day 1) · Abnormal, clinically significant	2 Participants	1 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (Day 1) · Abnormal, not clinically significant	2 Participants	1 Participants	5 Participants
Change in Electrocardiogram (ECG) Baseline (Day 1) · Indeterminate	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (Day 1) · Normal	7 Participants	10 Participants	7 Participants
Change in Electrocardiogram (ECG) Baseline (Day 1) · Not evaluable	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (Day 1) · Unknown	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 20 · Abnormal, clinically significant	1 Participants	0 Participants	1 Participants
Change in Electrocardiogram (ECG) Week 20 · Abnormal, not clinically significant	3 Participants	2 Participants	5 Participants
Change in Electrocardiogram (ECG) Week 20 · Indeterminate	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 20 · Normal	7 Participants	10 Participants	6 Participants
Change in Electrocardiogram (ECG) Week 20 · Not evaluable	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 20 · Unknown	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug. Number analyzed = Participants with available data for a specified category.

Change from baseline (Day 1) to week 20 in alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, LDH and lipase pancreatic is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Aspartate Aminotransferase	11.5 Units per liter (U/L) Standard Deviation 14.17	0.7 Units per liter (U/L) Standard Deviation 5.14	-0.6 Units per liter (U/L) Standard Deviation 9.84
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Gamma Glutamyl Transferase	7.0 Units per liter (U/L) Standard Deviation 11.37	5.8 Units per liter (U/L) Standard Deviation 5.19	0.4 Units per liter (U/L) Standard Deviation 8.03
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic LDH	19.5 Units per liter (U/L) Standard Deviation 28.24	15.9 Units per liter (U/L) Standard Deviation 15.26	2.5 Units per liter (U/L) Standard Deviation 15.71
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Lipase, Pancreatic	27.9 Units per liter (U/L) Standard Deviation 40.90	6.8 Units per liter (U/L) Standard Deviation 41.20	15.9 Units per liter (U/L) Standard Deviation 22.74
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Alanine Aminotransferase	21.9 Units per liter (U/L) Standard Deviation 34.61	5.6 Units per liter (U/L) Standard Deviation 6.32	3.9 Units per liter (U/L) Standard Deviation 13.96
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Alkaline Phosphatase	-6.2 Units per liter (U/L) Standard Deviation 18.14	-12.4 Units per liter (U/L) Standard Deviation 14.43	0.4 Units per liter (U/L) Standard Deviation 8.64
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Amylase	6.7 Units per liter (U/L) Standard Deviation 24.60	2.3 Units per liter (U/L) Standard Deviation 18.19	2.3 Units per liter (U/L) Standard Deviation 13.37
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic Creatine Kinase	19.9 Units per liter (U/L) Standard Deviation 49.88	3.2 Units per liter (U/L) Standard Deviation 38.00	-36.2 Units per liter (U/L) Standard Deviation 64.57

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug. 'Number Analyzed' = number of participants with available data for each category.

Change from baseline (Day 1) to Week 20 in bicarbonate, chloride, potassium and sodium is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Bicarbonate, Chloride, Potassium and Sodium Bicarbonate	-1.7 millimoles/L (mmol/L) Standard Deviation 2.00	-1.6 millimoles/L (mmol/L) Standard Deviation 2.68	-0.4 millimoles/L (mmol/L) Standard Deviation 3.73
Change From Baseline in Bicarbonate, Chloride, Potassium and Sodium Chloride	1.1 millimoles/L (mmol/L) Standard Deviation 2.21	1.3 millimoles/L (mmol/L) Standard Deviation 3.44	0.8 millimoles/L (mmol/L) Standard Deviation 2.73
Change From Baseline in Bicarbonate, Chloride, Potassium and Sodium Potassium	-0.30 millimoles/L (mmol/L) Standard Deviation 0.650	0.15 millimoles/L (mmol/L) Standard Deviation 0.284	-0.38 millimoles/L (mmol/L) Standard Deviation 0.501
Change From Baseline in Bicarbonate, Chloride, Potassium and Sodium Sodium	0.1 millimoles/L (mmol/L) Standard Deviation 2.47	0.0 millimoles/L (mmol/L) Standard Deviation 3.62	0.7 millimoles/L (mmol/L) Standard Deviation 3.26

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug. 'Number Analyzed' = number of participants with available data for each category.

Change from baseline (Day 1) to week 20 in bilirubin, calcium, creatinine, direct bilirubin, glucose, phosphate, urate and urea nitrogen is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Glucose	15.9 milligrams/deciliter (mg/dL) Standard Deviation 21.64	1.7 milligrams/deciliter (mg/dL) Standard Deviation 14.84	13.4 milligrams/deciliter (mg/dL) Standard Deviation 45.58
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Phosphate	0.22 milligrams/deciliter (mg/dL) Standard Deviation 0.374	0.29 milligrams/deciliter (mg/dL) Standard Deviation 0.287	-0.13 milligrams/deciliter (mg/dL) Standard Deviation 0.408
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Urate	0.47 milligrams/deciliter (mg/dL) Standard Deviation 1.084	0.06 milligrams/deciliter (mg/dL) Standard Deviation 0.611	0.27 milligrams/deciliter (mg/dL) Standard Deviation 1.113
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Urea nitrogen	5.5 milligrams/deciliter (mg/dL) Standard Deviation 8.23	6.3 milligrams/deciliter (mg/dL) Standard Deviation 7.76	3.3 milligrams/deciliter (mg/dL) Standard Deviation 11.87
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Creatinine	0.188 milligrams/deciliter (mg/dL) Standard Deviation 0.2368	0.210 milligrams/deciliter (mg/dL) Standard Deviation 0.2895	0.176 milligrams/deciliter (mg/dL) Standard Deviation 0.2087
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Bilirubin	0.158 milligrams/deciliter (mg/dL) Standard Deviation 0.3073	0.030 milligrams/deciliter (mg/dL) Standard Deviation 0.1566	-0.122 milligrams/deciliter (mg/dL) Standard Deviation 0.1497
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Calcium	-0.17 milligrams/deciliter (mg/dL) Standard Deviation 0.413	0.08 milligrams/deciliter (mg/dL) Standard Deviation 0.357	-0.10 milligrams/deciliter (mg/dL) Standard Deviation 0.429
Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen Direct bilirubin	0.039 milligrams/deciliter (mg/dL) Standard Deviation 0.0973	0.007 milligrams/deciliter (mg/dL) Standard Deviation 0.0350	-0.019 milligrams/deciliter (mg/dL) Standard Deviation 0.0198

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in glomerular filtration rate is presented. Glomerular filtration rate was calculated by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)creatinine equation.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Glomerular Filtration Rate	-3.5 mL/min/1.73m^2 Standard Deviation 3.98	-3.8 mL/min/1.73m^2 Standard Deviation 3.02	-3.9 mL/min/1.73m^2 Standard Deviation 5.90

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in protein is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Protein	-0.49 grams per deciliter (g/dL) Standard Deviation 0.617	-0.02 grams per deciliter (g/dL) Standard Deviation 0.397	-0.02 grams per deciliter (g/dL) Standard Deviation 0.296

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in eosinophils, leukocyctes, lymphocytes, monocytes, neutrophils and platelets is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils	-0.05 cells*10^9/L Standard Deviation 0.288	0.08 cells*10^9/L Standard Deviation 0.134	0.02 cells*10^9/L Standard Deviation 0.083
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocyctes	-0.96 cells*10^9/L Standard Deviation 1.615	-0.73 cells*10^9/L Standard Deviation 1.150	0.44 cells*10^9/L Standard Deviation 1.394
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes	-0.047 cells*10^9/L Standard Deviation 0.4840	0.066 cells*10^9/L Standard Deviation 0.3977	0.288 cells*10^9/L Standard Deviation 0.4916
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes	0.11 cells*10^9/L Standard Deviation 0.187	0.01 cells*10^9/L Standard Deviation 0.183	0.07 cells*10^9/L Standard Deviation 0.277
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils	-0.974 cells*10^9/L Standard Deviation 1.4803	-0.900 cells*10^9/L Standard Deviation 1.3441	0.062 cells*10^9/L Standard Deviation 1.0308
Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets	-35.7 cells*10^9/L Standard Deviation 22.10	-39.6 cells*10^9/L Standard Deviation 35.56	-0.1 cells*10^9/L Standard Deviation 46.23

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in eosinophil/leukocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Eosinophil/Leukocytes	-0.38 Percentage of eosinophil/leukocytes Standard Deviation 3.828	1.43 Percentage of eosinophil/leukocytes Standard Deviation 1.966	0.24 Percentage of eosinophil/leukocytes Standard Deviation 1.150

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in erythrocyte mean corpuscular volume is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Erythrocyte Mean Corpuscular Volume	2.44 femtoliters (fL) Standard Deviation 2.368	2.92 femtoliters (fL) Standard Deviation 1.243	0.18 femtoliters (fL) Standard Deviation 1.207

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in erythrocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Erythrocytes	-0.113 cells x 10^12/L Standard Deviation 0.2376	-0.095 cells x 10^12/L Standard Deviation 0.1951	-0.037 cells x 10^12/L Standard Deviation 0.2324

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in erythrocyte distribution width (ery. distribution width) is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Erythrocyte Distribution Width	-0.15 Percentage of ery. distribution width Standard Deviation 0.747	0.22 Percentage of ery. distribution width Standard Deviation 0.658	0.42 Percentage of ery. distribution width Standard Deviation 0.575

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in hematocrit is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Hematocrit	-0.1 Percentage of hematocrit Standard Deviation 2.39	0.3 Percentage of hematocrit Standard Deviation 2.05	-0.3 Percentage of hematocrit Standard Deviation 2.22

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in lymphocytes/leukocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Lymphocytes/Leukocytes	1.76 Percentage of lymphocytes/leukocytes Standard Deviation 5.710	4.62 Percentage of lymphocytes/leukocytes Standard Deviation 6.592	3.07 Percentage of lymphocytes/leukocytes Standard Deviation 4.980

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in monocytes/leukocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Monocytes/Leukocytes	2.05 Percentage of monocytes/leukocytes Standard Deviation 2.508	0.71 Percentage of monocytes/leukocytes Standard Deviation 2.831	0.50 Percentage of monocytes/leukocytes Standard Deviation 3.108

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in neutrophils/leukocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Neutrophils/Leukocytes	-3.32 Percentage of neutrophils/leukocytes Standard Deviation 6.201	-6.76 Percentage of neutrophils/leukocytes Standard Deviation 9.278	-3.82 Percentage of neutrophils/leukocytes Standard Deviation 6.593

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 20 in reticulocytes/erythrocytes is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Reticulocytes/Erythrocytes	-0.02 Percentage of reticulocytes/erythrocytes Standard Deviation 0.389	-0.04 Percentage of reticulocytes/erythrocytes Standard Deviation 0.345	0.11 Percentage of reticulocytes/erythrocytes Standard Deviation 0.847

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12

Population: The safety population included all randomized participants who received at least one dose of study drug. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Change from baseline (Day 1) to week 12 in protein creatinine ratio is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=10 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Protein Creatinine Ratio	-148.9 grams per kilogram (g/kg) Standard Deviation 830.30	-382.3 grams per kilogram (g/kg) Standard Deviation 729.52	412.3 grams per kilogram (g/kg) Standard Deviation 1783.53

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 12 in specific gravity of urine is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Specific Gravity of Urine	-0.0009 Ratio Standard Deviation 0.00263	-0.0002 Ratio Standard Deviation 0.00558	0.0013 Ratio Standard Deviation 0.00341

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 12 in spot urine albumin, spot urine creatinine, spot urine protein and urobilinogen is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Spot Urine Albumin, Spot Urine Creatinine, Spot Urine Protein and Urobilinogen Spot urine albumin	28.103 milligrams/deciliter (mg/dL) Standard Deviation 94.3076	-25.408 milligrams/deciliter (mg/dL) Standard Deviation 36.3713	48.863 milligrams/deciliter (mg/dL) Standard Deviation 132.0202
Change From Baseline in Spot Urine Albumin, Spot Urine Creatinine, Spot Urine Protein and Urobilinogen Spot urine creatinine	10.95 milligrams/deciliter (mg/dL) Standard Deviation 43.490	0.34 milligrams/deciliter (mg/dL) Standard Deviation 51.873	7.48 milligrams/deciliter (mg/dL) Standard Deviation 31.854
Change From Baseline in Spot Urine Albumin, Spot Urine Creatinine, Spot Urine Protein and Urobilinogen Spot urine protein	38.8 milligrams/deciliter (mg/dL) Standard Deviation 132.45	-61.7 milligrams/deciliter (mg/dL) Standard Deviation 92.90	51.7 milligrams/deciliter (mg/dL) Standard Deviation 162.06
Change From Baseline in Spot Urine Albumin, Spot Urine Creatinine, Spot Urine Protein and Urobilinogen Urobilinogen	0.00 milligrams/deciliter (mg/dL) Standard Deviation 0.000	-0.13 milligrams/deciliter (mg/dL) Standard Deviation 0.311	0.07 milligrams/deciliter (mg/dL) Standard Deviation 0.231

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12

Population: The safety population included all randomized participants who received at least one dose of study drug.

Change from baseline (Day 1) to week 12 in urine pH is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Change From Baseline in Urine pH	0.23 pH Standard Deviation 0.467	0.13 pH Standard Deviation 0.433	0.21 pH Standard Deviation 0.450

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

Percentage of participants with AEs leading to discontinuation of study drug is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Drug	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: The safety population included all randomized participants who received at least one dose of study drug.

AESIs included serious infection, Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than or equal to (\>=) 3 injection-related reactions, gastrointestinal perforations, CTCAE Grade \>=3 anaphylaxis that occurred at any time, even if considered unrelated to the study drug, neutrophil less than (\<) 500/mm\^3 (CTCAE Grade 4) or neutrophil \<1000/mm\^3 (CTCAE Grade 3) with evidence of concurrent infection, thrombocytopenia (platelet count \<50,000/mm\^3 \[CTCAE Grade 3\]) or platelet count \<75,000/mm\^3 (CTCAE Grade 2) with evidence of concurrent major bleeding and malignancies. Number of treatment emergent adverse events of special interest (AESIs) is presented.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=11 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 Participants Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=12 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Number of Treatment Emergent Adverse Events of Special Interest (AESIs)	1 Events	0 Events	1 Events

SECONDARY outcome

Timeframe: From randomization (Day 1) to week 20

Population: Analysis population included all randomized participants who had one or more evaluable sample after their first Ziltivekimab administration.

Number of participants with ADAs to Ziltivekimab is presented. Data presented is partcipants who had at least 1 positive antibody sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration.

Outcome measures

Outcome measures
Measure	Ziltivekimab 15 mg n=12 Participants Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	Placebo n=11 Participants Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
Number of Participants With Antidrug Antibodies (ADAs) to Ziltivekimab	0 Participants	—	0 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Ziltivekimab 15 mg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Ziltivekimab 30 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=12 participants at risk Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.	Ziltivekimab 15 mg n=11 participants at risk Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	Ziltivekimab 30 mg n=12 participants at risk Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.
Cardiac disorders Angina unstable	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
Infections and infestations Appendicitis	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
Infections and infestations Corona virus infection	8.3% 1/12 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
General disorders Impaired healing	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	9.1% 1/11 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.
Renal and urinary disorders Nephrotic syndrome	8.3% 1/12 • Number of events 1 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/11 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.	0.00% 0/12 • From randomization (Day 1) to week 20 All presented adverse events are treatment emergent (i.e. TEAEs). A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). The safety population included all randomized participants who received at least one dose of study drug.

Other adverse events

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

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