Trial Outcomes & Findings for Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition (NCT NCT03926117)

NCT ID: NCT03926117

Last Updated: 2025-12-31

Results Overview

Percent change from baseline in hs-CRP levels at week 13 are presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

264 participants

Primary outcome timeframe

Baseline (average of the hs-CRP value prior to randomization and day 1), week 13

Results posted on

2025-12-31

Participant Flow

The trial was conducted at 52 clinical sites in the United States.

Participants were randomized 1:1:1:1 to one of three Ziltivekimab dose levels (7.5 milligram (mg), 15 mg, or 30 mg) or matching placebo.

Participant milestones

Participant milestones
Measure	Ziltivekimab 7.5 mg Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Placebo Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Overall Study STARTED	66	66	66	66
Overall Study Intent-to-treat Analysis Population	66	66	66	66
Overall Study Safety Analysis Population	65	66	65	65
Overall Study Treated	65	66	65	65
Overall Study COMPLETED	57	60	59	60
Overall Study NOT COMPLETED	9	6	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ziltivekimab 7.5 mg Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Placebo Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Overall Study Unclassified	4	1	4	1
Overall Study Withdrawal by Subject	0	1	1	3
Overall Study Lost to Follow-up	2	1	0	0
Overall Study Adverse Event	2	3	1	1
Overall Study Randomized but not treated	1	0	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=66 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=66 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=66 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Total n=264 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 10.81 • n=1000 Participants	67.2 years STANDARD_DEVIATION 10.67 • n=1986 Participants	65.9 years STANDARD_DEVIATION 9.42 • n=2008 Participants	67.1 years STANDARD_DEVIATION 10.55 • n=4994 Participants	66.4 years STANDARD_DEVIATION 10.35 • n=62 Participants
Sex: Female, Male Female	29 Participants n=1000 Participants	32 Participants n=1986 Participants	36 Participants n=2008 Participants	32 Participants n=4994 Participants	129 Participants n=62 Participants
Sex: Female, Male Male	37 Participants n=1000 Participants	34 Participants n=1986 Participants	30 Participants n=2008 Participants	34 Participants n=4994 Participants	135 Participants n=62 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=1000 Participants	12 Participants n=1986 Participants	15 Participants n=2008 Participants	19 Participants n=4994 Participants	71 Participants n=62 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=1000 Participants	54 Participants n=1986 Participants	51 Participants n=2008 Participants	46 Participants n=4994 Participants	192 Participants n=62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1000 Participants	0 Participants n=1986 Participants	0 Participants n=2008 Participants	1 Participants n=4994 Participants	1 Participants n=62 Participants
Race/Ethnicity, Customized Race · White	50 Participants n=1000 Participants	48 Participants n=1986 Participants	49 Participants n=2008 Participants	52 Participants n=4994 Participants	199 Participants n=62 Participants
Race/Ethnicity, Customized Race · Black or African American	16 Participants n=1000 Participants	18 Participants n=1986 Participants	12 Participants n=2008 Participants	14 Participants n=4994 Participants	60 Participants n=62 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=1000 Participants	0 Participants n=1986 Participants	3 Participants n=2008 Participants	0 Participants n=4994 Participants	3 Participants n=62 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants	0 Participants n=4994 Participants	1 Participants n=62 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants	0 Participants n=4994 Participants	1 Participants n=62 Participants

PRIMARY outcome

Timeframe: Baseline (average of the hs-CRP value prior to randomization and day 1), week 13

Population: ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

Percent change from baseline in hs-CRP levels at week 13 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=58 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=61 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=57 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels	-4.49 Percent change Interval -35.54 to 46.27	-76.57 Percent change Interval -86.89 to -57.14	-88.12 Percent change Interval -92.11 to -78.95	-91.64 Percent change Interval -95.19 to -86.15

SECONDARY outcome

Timeframe: Baseline (average of the values at week -1 and day 1), week 13

Population: ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

Percent change from baseline in SAA at week 13 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=58 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=60 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=56 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percent Change From Baseline in Serum Amyloid A (SAA)	1.82 Percent change Interval -18.42 to 50.98	-40.24 Percent change Interval -61.54 to -12.38	-49.80 Percent change Interval -63.9 to -31.54	-42.45 Percent change Interval -68.91 to -13.48

SECONDARY outcome

Timeframe: Baseline (day 1), week 13

Population: ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

Percent change from baseline in fibrinogen at week 13 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=55 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=60 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=54 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percent Change From Baseline in Fibrinogen	-1.62 Percent change Interval -12.9 to 13.35	-25.20 Percent change Interval -33.27 to -7.93	-24.69 Percent change Interval -36.25 to -16.48	-37.17 Percent change Interval -44.94 to -28.57

SECONDARY outcome

Timeframe: From week 0 to week 32

Population: The safety analysis population included all randomized participants who received at least 1 dose of study drug.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAEs are defined as AEs that initiated or worsened on or after the date of first dose of study drug up to the end of safety-follow-up. A 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. TEAEs that met any of these criteria were considered severe hematologic AEs: grade 3 neutropenia, grade 3 anemia, grade 3 leukopenia, grade 3 lymphopenia, grade 3 eosinophilia, and grade 3 thrombocytopenia.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=65 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation TEAEs	69.2 Percentage of participants	66.2 Percentage of participants	66.7 Percentage of participants	72.3 Percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation TESAEs	15.4 Percentage of participants	20.0 Percentage of participants	13.6 Percentage of participants	12.3 Percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation Severe hematologic AEs	1.5 Percentage of participants	0.0 Percentage of participants	1.5 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation Severe non-hematologic AEs	10.8 Percentage of participants	18.5 Percentage of participants	9.1 Percentage of participants	12.3 Percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation AEs leading to study drug discontinuation	4.6 Percentage of participants	6.2 Percentage of participants	7.6 Percentage of participants	4.6 Percentage of participants

SECONDARY outcome

Timeframe: From week 0 to week 32

Population: The safety analysis population included all randomized participants who received at least 1 dose of study drug.

Bleeding events were classified using the TIMI bleeding classification as follows: 1) major: intracranial hemorrhage or a \>=5 g/dL decrease in the hemoglobin concentration or a \>=15 percent (%) absolute decrease in the hematocrit; 2) minor: (a) observed blood loss: \>=3 g/dL decrease in the hemoglobin concentration or \>=10% decrease in the hematocrit. (b) no observed blood loss: \>=4 g/dL decrease in the hemoglobin concentration or \>=12% decrease in the hematocrit; 3) minimal: any clinically overt sign of hemorrhage (including imaging) that was associated with a \< 3 g/dL decrease in the hemoglobin concentration or \<9% decrease in the hematocrit.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=65 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From week 0 to week 32

Population: The safety analysis population included all randomized participants who received at least 1 dose of study drug.

An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AESI included serious infections, malignancies, anaphylaxis occurring at any time, even if considered unrelated to the study drug, gastrointestinal perforations, hypersensitivity reaction during investigational product (IP) administration, neutrophils per cubic millimeter (500/mm\^3) (severe) or neutrophils \<1000/mm\^3 (severe) with evidence of concurrent infection, severe injection-related reactions, thrombocytopenia (platelet count \<50,000/mm\^3 (severe)) or platelet count \<75,000/mm\^3 (moderate) with evidence of concurrent TIMI major bleeding.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=65 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Serious infection	4.6 Percentage of participants	10.8 Percentage of participants	4.5 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Malignancy	1.5 Percentage of participants	0.0 Percentage of participants	1.5 Percentage of participants	1.5 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Anaphylaxis	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Gastrointestinal perforations	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Hypersensitivity reaction during IP administration	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Severe injection-related reaction	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Neutropenia, severe	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Neutropenia, severe with evidence of concurrent infection	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Thrombocytopenia, moderate with evidence of concurrent TIMI major bleeding	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) Thrombocytopenia, severe	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Population: The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data.

Change from baseline in systolic blood pressure at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=52 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Systolic Blood Pressure (SBP)	4.8 Millimeters of mercury (mmHg) Standard Deviation 15.94	4.9 Millimeters of mercury (mmHg) Standard Deviation 16.31	0.6 Millimeters of mercury (mmHg) Standard Deviation 18.89	1.2 Millimeters of mercury (mmHg) Standard Deviation 14.71

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in diastolic blood pressure at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=52 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Diastolic Blood Pressure (DBP)	0.7 mmHg Standard Deviation 10.33	2.9 mmHg Standard Deviation 10.97	1.1 mmHg Standard Deviation 11.17	3.1 mmHg Standard Deviation 10.35

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in respiratory rate at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=52 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Respiratory Rate	0.4 Breaths per minute (breaths/min) Standard Deviation 2.24	0.2 Breaths per minute (breaths/min) Standard Deviation 2.18	-0.7 Breaths per minute (breaths/min) Standard Deviation 2.36	-0.5 Breaths per minute (breaths/min) Standard Deviation 1.62

SECONDARY outcome

Timeframe: Baseline (week 1), week 24

Change from baseline in BMI at week 24 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=32 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=31 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=34 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=30 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Body Mass Index (BMI)	0.13 Kilograms per square meter (kg/m^2) Standard Deviation 1.102	0.51 Kilograms per square meter (kg/m^2) Standard Deviation 1.904	0.58 Kilograms per square meter (kg/m^2) Standard Deviation 1.664	0.40 Kilograms per square meter (kg/m^2) Standard Deviation 0.879

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in heart rate at Week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=52 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Heart Rate	2.8 Beats per minute (beats/min) Standard Deviation 9.70	1.5 Beats per minute (beats/min) Standard Deviation 10.18	-0.6 Beats per minute (beats/min) Standard Deviation 8.93	1.2 Beats per minute (beats/min) Standard Deviation 11.56

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in temperature at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=52 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Temperature	0.03 Degree Celsius (°C) Standard Deviation 0.456	-0.01 Degree Celsius (°C) Standard Deviation 0.430	-1.13 Degree Celsius (°C) Standard Deviation 8.366	-0.02 Degree Celsius (°C) Standard Deviation 0.615

SECONDARY outcome

Timeframe: Baseline (week -1), Week 24

The ECG was assessed by the investigator at baseline (week -1) and week 24 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 24 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=65 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=64 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Electrocardiogram (ECG) Baseline (week-1) · Abnormal, not clinically significant	44 Participants	38 Participants	40 Participants	46 Participants
Change in Electrocardiogram (ECG) Baseline (week-1) · Indeterminate	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (week-1) · Normal	21 Participants	27 Participants	25 Participants	18 Participants
Change in Electrocardiogram (ECG) Baseline (week-1) · Not evaluable	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (week-1) · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 24 · Abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 24 · Abnormal, not clinically significant	36 Participants	32 Participants	35 Participants	34 Participants
Change in Electrocardiogram (ECG) Week 24 · Indeterminate	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 24 · Normal	14 Participants	22 Participants	18 Participants	18 Participants
Change in Electrocardiogram (ECG) Week 24 · Not evaluable	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 24 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Baseline (week-1) · Abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in ALP, ALT and AAT levels at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=53 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels ALP: Change from baseline to Week 32	-1.9 Units per liter (U/L) Standard Deviation 14.75	-6.3 Units per liter (U/L) Standard Deviation 18.28	-9.6 Units per liter (U/L) Standard Deviation 18.56	-15.7 Units per liter (U/L) Standard Deviation 13.94
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels ALT: Change from baseline to Week 32	1.3 Units per liter (U/L) Standard Deviation 5.53	2.6 Units per liter (U/L) Standard Deviation 6.56	5.3 Units per liter (U/L) Standard Deviation 11.76	7.2 Units per liter (U/L) Standard Deviation 13.73
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels AAT: Change from baseline to Week 32	0.6 Units per liter (U/L) Standard Deviation 6.05	2.3 Units per liter (U/L) Standard Deviation 4.65	3.3 Units per liter (U/L) Standard Deviation 8.28	4.8 Units per liter (U/L) Standard Deviation 9.15

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in bicarbonate, chloride, potassium, sodium at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=53 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Bicarbonate, Chloride, Potassium, Sodium Bicarbonate: Change from baseline to Week 32	-0.9 millimoles per liter (mmol/L) Standard Deviation 2.60	-0.3 millimoles per liter (mmol/L) Standard Deviation 2.66	-0.7 millimoles per liter (mmol/L) Standard Deviation 2.96	-1.2 millimoles per liter (mmol/L) Standard Deviation 2.72
Change in Bicarbonate, Chloride, Potassium, Sodium Chloride: Change from baseline to Week 32	1.7 millimoles per liter (mmol/L) Standard Deviation 3.86	0.0 millimoles per liter (mmol/L) Standard Deviation 3.27	0.7 millimoles per liter (mmol/L) Standard Deviation 2.95	0.9 millimoles per liter (mmol/L) Standard Deviation 3.39
Change in Bicarbonate, Chloride, Potassium, Sodium Potassium: Change from baseline to Week 32	0.00 millimoles per liter (mmol/L) Standard Deviation 0.445	-0.28 millimoles per liter (mmol/L) Standard Deviation 0.739	-0.29 millimoles per liter (mmol/L) Standard Deviation 0.570	-0.16 millimoles per liter (mmol/L) Standard Deviation 0.567
Change in Bicarbonate, Chloride, Potassium, Sodium Sodium: Change from baseline to Week 32	1.0 millimoles per liter (mmol/L) Standard Deviation 2.92	0.0 millimoles per liter (mmol/L) Standard Deviation 2.70	0.3 millimoles per liter (mmol/L) Standard Deviation 2.44	-0.1 millimoles per liter (mmol/L) Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline (week 1), week 32

Change from baseline in direct bilirubin, bilirubin, calcium, creatinine, glucose, phosphate and urea nitrogen at week 32 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=53 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=55 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=53 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Direct Bilirubin: Change from baseline to Week 32	-0.007 milligrams per deciliter (mg/dL) Standard Deviation 0.0297	0.008 milligrams per deciliter (mg/dL) Standard Deviation 0.0263	0.018 milligrams per deciliter (mg/dL) Standard Deviation 0.0300	0.009 milligrams per deciliter (mg/dL) Standard Deviation 0.0367
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Bilirubin: Change from baseline to Week 32	-0.028 milligrams per deciliter (mg/dL) Standard Deviation 0.1284	0.060 milligrams per deciliter (mg/dL) Standard Deviation 0.1013	0.105 milligrams per deciliter (mg/dL) Standard Deviation 0.1576	0.065 milligrams per deciliter (mg/dL) Standard Deviation 0.1812
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Calcium: Change from baseline to Week 32	-0.04 milligrams per deciliter (mg/dL) Standard Deviation 0.494	0.09 milligrams per deciliter (mg/dL) Standard Deviation 0.407	0.16 milligrams per deciliter (mg/dL) Standard Deviation 0.524	0.11 milligrams per deciliter (mg/dL) Standard Deviation 0.405
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Creatinine: Change from baseline to Week 32	-0.041 milligrams per deciliter (mg/dL) Standard Deviation 0.6114	0.216 milligrams per deciliter (mg/dL) Standard Deviation 0.5291	0.054 milligrams per deciliter (mg/dL) Standard Deviation 0.3404	0.141 milligrams per deciliter (mg/dL) Standard Deviation 0.4618
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Glucose: Change from baseline to Week 32	-15.1 milligrams per deciliter (mg/dL) Standard Deviation 83.48	8.9 milligrams per deciliter (mg/dL) Standard Deviation 80.50	9.2 milligrams per deciliter (mg/dL) Standard Deviation 64.86	1.7 milligrams per deciliter (mg/dL) Standard Deviation 48.43
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Phosphate: Change from baseline to Week 32	-0.04 milligrams per deciliter (mg/dL) Standard Deviation 0.778	0.04 milligrams per deciliter (mg/dL) Standard Deviation 0.766	0.02 milligrams per deciliter (mg/dL) Standard Deviation 0.620	0.21 milligrams per deciliter (mg/dL) Standard Deviation 0.641
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen Urea Nitrogen: Change from baseline to Week 32	0.4 milligrams per deciliter (mg/dL) Standard Deviation 11.76	4.7 milligrams per deciliter (mg/dL) Standard Deviation 12.15	1.6 milligrams per deciliter (mg/dL) Standard Deviation 7.97	5.6 milligrams per deciliter (mg/dL) Standard Deviation 13.89

SECONDARY outcome

Timeframe: Baseline (week -1)

FSH levels at baseline (week -1) are presented.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=15 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=16 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=13 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Follicle Stimulating Hormone (FSH) Levels	57.45 International units per liter (IU/L) Standard Deviation 20.496	72.70 International units per liter (IU/L) Standard Deviation 36.519	77.49 International units per liter (IU/L) Standard Deviation 33.827	58.79 International units per liter (IU/L) Standard Deviation 48.167

SECONDARY outcome

Timeframe: From week 0 to week 32

Population: Analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.

Participants who had at least 1 positive sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration were classified as positive for ADAs. In the instance that a participant had a positive sample at the baseline visit, the participant was considered positive only if the peak titer of the post-treatment sample was at least 2-fold higher (i.e., \>=2-fold) than the titer of the baseline sample. Number of participants positive for antibodies to Ziltivekimab are presented.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 Participants Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 Participants Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=64 Participants Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Number of Participants With Anti-drug Antibodies (ADAs)	0 Participants	4 Participants	5 Participants	7 Participants

Adverse Events

Placebo

Serious events: 10 serious events

Other events: 19 other events

Deaths: 1 deaths

Ziltivekimab 7.5 mg

Serious events: 13 serious events

Other events: 22 other events

Deaths: 0 deaths

Ziltivekimab 15 mg

Serious events: 9 serious events

Other events: 18 other events

Deaths: 0 deaths

Ziltivekimab 30 mg

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=65 participants at risk Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 7.5 mg n=65 participants at risk Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 15 mg n=66 participants at risk Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.	Ziltivekimab 30 mg n=65 participants at risk Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 1/65 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 5 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	3.0% 2/66 • Number of events 2 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	1.5% 1/65 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 5/65 • Number of events 5 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	1.5% 1/65 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.5% 3/66 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	3.1% 2/65 • Number of events 2 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	9.2% 6/65 • Number of events 6 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	3.1% 2/65 • Number of events 2 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	1.5% 1/66 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.6% 3/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	1.5% 1/65 • Number of events 2 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.6% 3/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.1% 4/66 • Number of events 4 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.6% 3/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	3.1% 2/65 • Number of events 2 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	7.7% 5/65 • Number of events 6 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	9.1% 6/66 • Number of events 6 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	0.00% 0/65 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypovolaemia	3.1% 2/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 5 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	0.00% 0/66 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	0.00% 0/65 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	1.5% 1/65 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 4 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.5% 3/66 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.6% 3/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
General disorders Oedema peripheral	3.1% 2/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 4 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	1.5% 1/66 • Number of events 1 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 5 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	6.2% 4/65 • Number of events 5 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	6.2% 4/65 • Number of events 4 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.5% 3/66 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.	4.6% 3/65 • Number of events 3 • From week 0 to week 32 All presented AEs are treatment-emergent adverse events (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 (week 32). The results are based on the safety analysis set which included all randomized participants who received at least one dose of study drug.

Additional Information

Clinical Reporting Office (1452)

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