Trial Outcomes & Findings for A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure (NCT NCT06142383)

NCT ID: NCT06142383

Last Updated: 2025-12-24

Results Overview

Summary statistics for observed NT-proBNP values are reported: Geometric mean ratio to baseline at week 16 is calculated by the geometric mean of the ratio of the week 16 value to the baseline value. Baseline is defined as the value at randomization visit.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 136 participants
• Primary outcome timeframe: Baseline and week 16
• Results posted on: 2025-12-24

Participant Flow

All eligible participants were randomized via a validated Interactive Response Technology (IRT) to one of the treatment arms. Randomization was stratified by 2 factors: region, and ACEI/ARB or sacubitril/valsartan background treatment, respectively. Stratified randomization ensured that arms 1-4 had 1:2 ratio of participants on ACEI/ARB or sacubitril/valsartan background treatment, respectively, and arm 5 had only participants on prior ACEI/ARB background treatment.

Participant milestones

Measure	XXB750 Placebo (Arm 1) XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	XXB750 240 mg (Arm 4) No participants were exposed to the planned highest target dose of 240 mg	Sacubitril/Valsartan (Arm 5) Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Overall Study STARTED	29	26	56	0	25
Overall Study Full analysis set (FAS)	29	26	55	0	25
Overall Study Safety set (SAF)	29	26	54	0	25
Overall Study COMPLETED	9	6	16	0	3
Overall Study NOT COMPLETED	20	20	40	0	22

Reasons for withdrawal

Measure	XXB750 Placebo (Arm 1) XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	XXB750 240 mg (Arm 4) No participants were exposed to the planned highest target dose of 240 mg	Sacubitril/Valsartan (Arm 5) Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Overall Study Mis-randomized	0	0	1	0	0
Overall Study Adverse Event	0	1	1	0	0
Overall Study Death	0	1	3	0	1
Overall Study Study Terminated by Sponsor	20	17	33	0	21
Overall Study Subject Decision	0	1	2	0	0

Baseline Characteristics

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

Baseline characteristics by cohort

Measure	XXB750 Placebo (Arm 1) n=29 Participants XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) n=26 Participants XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) n=55 Participants XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	XXB750 240 mg (Arm 4) No participants were exposed to the planned highest target dose of 240 mg	Sacubitril/Valsartan (Arm 5) n=25 Participants Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=5449 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=30 Participants	8 Participants n=30 Participants	16 Participants n=60 Participants	0 Participants n=219 Participants	12 Participants n=880 Participants	43 Participants n=5449 Participants
Age, Categorical >=65 years	22 Participants n=30 Participants	18 Participants n=30 Participants	39 Participants n=60 Participants	0 Participants n=219 Participants	13 Participants n=880 Participants	92 Participants n=5449 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 11.0 • n=30 Participants	69.6 years STANDARD_DEVIATION 9.7 • n=30 Participants	70.1 years STANDARD_DEVIATION 10.0 • n=60 Participants	—	67.3 years STANDARD_DEVIATION 11.6 • n=880 Participants	69.8 years STANDARD_DEVIATION 10.5 • n=5449 Participants
Sex: Female, Male Female	8 Participants n=30 Participants	9 Participants n=30 Participants	14 Participants n=60 Participants	0 Participants n=219 Participants	10 Participants n=880 Participants	41 Participants n=5449 Participants
Sex: Female, Male Male	21 Participants n=30 Participants	17 Participants n=30 Participants	41 Participants n=60 Participants	0 Participants n=219 Participants	15 Participants n=880 Participants	94 Participants n=5449 Participants
Race/Ethnicity, Customized White	25 Participants n=30 Participants	24 Participants n=30 Participants	43 Participants n=60 Participants	0 Participants n=219 Participants	22 Participants n=880 Participants	114 Participants n=5449 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=30 Participants	1 Participants n=30 Participants	6 Participants n=60 Participants	0 Participants n=219 Participants	1 Participants n=880 Participants	10 Participants n=5449 Participants
Race/Ethnicity, Customized Asian	2 Participants n=30 Participants	1 Participants n=30 Participants	6 Participants n=60 Participants	0 Participants n=219 Participants	2 Participants n=880 Participants	11 Participants n=5449 Participants

PRIMARY outcome

Timeframe: Baseline and week 16

Population: Full analysis set, which includes all participants to whom study treatment has been assigned by randomization, except for those who have not been qualified for this (and have therefore not received any study drug) but have been inadvertently randomized into the trial. Only participants with a value at both baseline and week 16 visit are included for calculating geometric mean change from baseline at week 16.

Summary statistics for observed NT-proBNP values are reported: Geometric mean ratio to baseline at week 16 is calculated by the geometric mean of the ratio of the week 16 value to the baseline value. Baseline is defined as the value at randomization visit.

Outcome measures

Measure	XXB750 Placebo (Arm 1) n=28 Participants XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) n=21 Participants XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) n=45 Participants XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	XXB750 240 mg (Arm 4) No participants were exposed to the planned highest target dose of 240 mg	Sacubitril/Valsartan (Arm 5) n=21 Participants Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Geometric Mean Ratio to Baseline in NT-proBNP at Week 16	0.903 unitless Interval 0.696 to 1.172	1.021 unitless Interval 0.717 to 1.453	1.515 unitless Interval 1.147 to 2.001	—	0.701 unitless Interval 0.446 to 1.102

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Full analysis set. Only participants with a value at baseline visit are included

Baseline is defined as the NT-proBNP value at randomization visit.

Outcome measures

Measure	XXB750 Placebo (Arm 1) n=29 Participants XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) n=26 Participants XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) n=54 Participants XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	XXB750 240 mg (Arm 4) No participants were exposed to the planned highest target dose of 240 mg	Sacubitril/Valsartan (Arm 5) n=25 Participants Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Baseline NT-proBNP Levels	211.910 pmol/L Interval 142.532 to 315.058	163.501 pmol/L Interval 116.109 to 230.236	166.327 pmol/L Interval 132.519 to 208.761	—	186.753 pmol/L Interval 136.068 to 256.318

Adverse Events

XXB750 Placebo (Arm 1)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

XXB750 60 mg (Arm 2)

Serious events: 8 serious events

Other events: 16 other events

Deaths: 1 deaths

XXB750 120 mg (Arm 3)

Serious events: 18 serious events

Other events: 24 other events

Deaths: 3 deaths

Sacubitril/Valsartan (Arm 5)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Measure	XXB750 Placebo (Arm 1) n=29 participants at risk XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) n=26 participants at risk XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) n=54 participants at risk XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	Sacubitril/Valsartan (Arm 5) n=25 participants at risk Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Cardiac disorders Acute coronary syndrome	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Angina unstable	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac arrest	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac dysfunction	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	9.3% 5/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure acute	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure chronic	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure congestive	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Ventricular tachycardia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Duodenitis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Melaena	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Death	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Hepatobiliary disorders Post cholecystectomy syndrome	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Cellulitis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Endocarditis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Enterococcal sepsis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Pneumonia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	7.7% 2/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Femoral neck fracture	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Head injury	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Nervous system disorders Cerebral infarction	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Nervous system disorders Ischaemic stroke	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Nervous system disorders Movement disorder	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Acute kidney injury	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	11.5% 3/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Chronic kidney disease	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Hypertension	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Hypotension	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.

Other adverse events

Measure	XXB750 Placebo (Arm 1) n=29 participants at risk XXB750 Placebo SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 60 mg (Arm 2) n=26 participants at risk XXB750 60 mg SC injection every 4 weeks during the randomized treatment period (Day 1, Week 4, Week 8 and Week 12)	XXB750 120 mg (Arm 3) n=54 participants at risk XXB750 60 mg SC injection on Day 1 followed by XXB750 120 mg SC injection every 4 weeks during the randomized treatment period (Week 4, Week 8 and Week 12)	Sacubitril/Valsartan (Arm 5) n=25 participants at risk Participants switched from their pre-study ACEI/ARB treatment to open label tablet Sacubitril/valsartan, target dose 97/103 mg bid (Sac/Val)
Blood and lymphatic system disorders Anaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Atrial fibrillation	6.9% 2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	15.4% 4/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	13.0% 7/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Cardiac failure congestive	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Palpitations	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Cardiac disorders Ventricular tachycardia	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Eye disorders Dry eye	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Constipation	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Gastritis	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Gastrointestinal disorders Salivary gland calculus	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Asthenia	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Chest pain	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Gait disturbance	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Influenza like illness	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Malaise	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
General disorders and administration site conditions Pyrexia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Bronchitis	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations COVID-19	6.9% 2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Erysipelas	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Gastroenteritis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Gastroenteritis viral	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Influenza	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Nasopharyngitis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Pneumonia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Infections and infestations Urinary tract infection	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	11.5% 3/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	8.0% 2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Chest injury	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Contusion	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Fall	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Skin abrasion	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Injury, poisoning and procedural complications Subcutaneous haematoma	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations Blood creatinine increased	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	12.0% 3/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations Blood glucose increased	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations Blood urea increased	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	7.7% 2/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	8.0% 2/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations Breath sounds abnormal	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Investigations Protein urine present	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Nervous system disorders Cerebral microangiopathy	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Psychiatric disorders Insomnia	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Chronic kidney disease	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Dysuria	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Proteinuria	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Renal and urinary disorders Renal impairment	3.4% 1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	15.4% 4/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	7.4% 4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	1.9% 1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.8% 1/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Hypertension	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	3.7% 2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Hypotension	6.9% 2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	15.4% 4/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	13.0% 7/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	24.0% 6/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Orthostatic hypotension	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.
Vascular disorders Thrombophlebitis	0.00% 0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/26 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	0.00% 0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.	4.0% 1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum duration of 24 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER