Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx (NCT NCT04083222)
NCT ID: NCT04083222
Last Updated: 2023-01-18
Results Overview
The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline up to Day 57 (start of Week 9)
Results posted on
2023-01-18
Participant Flow
Participants took part in the study at 9 investigative sites from 13 November 2019 to 20 July 2020.
A total of 64 participants were screened out of which 26 were enrolled and randomized in 2:1 ratio to receive either ISIS 757456 80 mg or placebo.
Participant milestones
| Measure |
Placebo
Participants received ISIS 757456-matching placebo, subcutaneous (SC) injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
18
|
|
Overall Study
COMPLETED
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received ISIS 757456-matching placebo, subcutaneous (SC) injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Overall Study
Voluntary Withdrawal
|
0
|
1
|
|
Overall Study
Reason not Specified
|
0
|
1
|
Baseline Characteristics
Per Protocol Set (PPS) included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments.
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=18 Participants
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10 • n=8 Participants
|
60 years
STANDARD_DEVIATION 8 • n=18 Participants
|
60 years
STANDARD_DEVIATION 9 • n=26 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
14 Participants
n=18 Participants
|
20 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=8 Participants
|
8 Participants
n=18 Participants
|
10 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
16 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
7 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=8 Participants
|
15 Participants
n=18 Participants
|
19 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=26 Participants
|
|
Plasma Angiotensinogen (AGT)
|
25.5 micrograms per milliliter (μg/mL)
STANDARD_DEVIATION 4.4 • n=8 Participants • Per Protocol Set (PPS) included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments.
|
25.2 micrograms per milliliter (μg/mL)
STANDARD_DEVIATION 3.4 • n=16 Participants • Per Protocol Set (PPS) included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments.
|
25.3 micrograms per milliliter (μg/mL)
STANDARD_DEVIATION 3.7 • n=24 Participants • Per Protocol Set (PPS) included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments.
|
PRIMARY outcome
Timeframe: Baseline up to Day 57 (start of Week 9)Population: PPS included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments.
The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=16 Participants
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 57 Compared to Placebo
|
-3.4 percent change
Standard Deviation 17.8
|
-67.4 percent change
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141Population: PPS included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments. 'Number analyzed' indicates the number of participants with available data at the specific timepoint.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=16 Participants
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 57
|
-5 mmHg
Standard Deviation 10
|
-12 mmHg
Standard Deviation 16
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 64
|
-8 mmHg
Standard Deviation 16
|
-16 mmHg
Standard Deviation 11
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 78
|
-8 mmHg
Standard Deviation 14
|
-12 mmHg
Standard Deviation 13
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 92
|
-5 mmHg
Standard Deviation 13
|
-15 mmHg
Standard Deviation 15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Baseline
|
152 mmHg
Standard Deviation 8
|
153 mmHg
Standard Deviation 10
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 3
|
-6 mmHg
Standard Deviation 15
|
-12 mmHg
Standard Deviation 14
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 8
|
-8 mmHg
Standard Deviation 9
|
-14 mmHg
Standard Deviation 15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 15
|
-0 mmHg
Standard Deviation 16
|
-9 mmHg
Standard Deviation 13
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 22
|
-8 mmHg
Standard Deviation 15
|
-8 mmHg
Standard Deviation 16
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 29
|
3 mmHg
Standard Deviation 14
|
-8 mmHg
Standard Deviation 16
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 36
|
0 mmHg
Standard Deviation 15
|
-13 mmHg
Standard Deviation 15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 43
|
-2 mmHg
Standard Deviation 9
|
-11 mmHg
Standard Deviation 12
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 50
|
-3 mmHg
Standard Deviation 12
|
-17 mmHg
Standard Deviation 16
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 120
|
-3 mmHg
Standard Deviation 10
|
-10 mmHg
Standard Deviation 14
|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 141
|
0 mmHg
Standard Deviation 13
|
-11 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141Population: PPS included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments. 'Number analyzed' indicates the number of participants with available data at the specific timepoint.
The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=16 Participants
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Baseline
|
25.5 ug/mL
Standard Deviation 4.4
|
25.2 ug/mL
Standard Deviation 3.4
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 3
|
-1.7 ug/mL
Standard Deviation 2.3
|
-2.5 ug/mL
Standard Deviation 4.2
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 8
|
-1.5 ug/mL
Standard Deviation 3.1
|
-9.6 ug/mL
Standard Deviation 4.3
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 15
|
-1.6 ug/mL
Standard Deviation 2.1
|
-13.4 ug/mL
Standard Deviation 5.7
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 22
|
-0.7 ug/mL
Standard Deviation 1.6
|
-15.7 ug/mL
Standard Deviation 4.7
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 29
|
-0.8 ug/mL
Standard Deviation 3.9
|
-17.1 ug/mL
Standard Deviation 4.0
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 36
|
-2.0 ug/mL
Standard Deviation 2.6
|
-17.2 ug/mL
Standard Deviation 4.0
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 43
|
-2.9 ug/mL
Standard Deviation 2.5
|
-17.5 ug/mL
Standard Deviation 3.7
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 50
|
-2.2 ug/mL
Standard Deviation 3.2
|
-17.7 ug/mL
Standard Deviation 3.8
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 57
|
-1.1 ug/mL
Standard Deviation 4.5
|
-17.0 ug/mL
Standard Deviation 4.1
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 64
|
-4.3 ug/mL
Standard Deviation 3.7
|
-15.9 ug/mL
Standard Deviation 3.7
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 78
|
-3.0 ug/mL
Standard Deviation 3.1
|
-12.9 ug/mL
Standard Deviation 3.9
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 92
|
-1.7 ug/mL
Standard Deviation 3.9
|
-9.8 ug/mL
Standard Deviation 4.2
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 120
|
-3.1 ug/mL
Standard Deviation 1.9
|
-5.7 ug/mL
Standard Deviation 4.0
|
|
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Change From Baseline at Day 141
|
-3.4 ug/mL
Standard Deviation 4.7
|
-5.8 ug/mL
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 64, 78, 92, 120, and 141Population: PPS included all randomized participants who had at least 1 post-baseline efficacy or exploratory measurement, received at least 7 of the 9 doses of study drug, did not alter antihypertensive medications during the treatment period and prior to Day 57, and had no significant protocol deviations that would have been expected to affect efficacy or exploratory assessments. 'Number analyzed' indicates the number of participants with available data at the specific timepoint.
The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=16 Participants
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 8
|
-4.8 percent change
Standard Deviation 12.9
|
-38.5 percent change
Standard Deviation 16.6
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 15
|
-6.6 percent change
Standard Deviation 8.1
|
-53.3 percent change
Standard Deviation 22.1
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 43
|
-10.6 percent change
Standard Deviation 8.2
|
-69.5 percent change
Standard Deviation 11.3
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 50
|
-7.9 percent change
Standard Deviation 11.4
|
-70.3 percent change
Standard Deviation 11.1
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 22
|
-2.4 percent change
Standard Deviation 6.3
|
-62.4 percent change
Standard Deviation 17.9
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 29
|
-2.8 percent change
Standard Deviation 15.5
|
-67.9 percent change
Standard Deviation 13.5
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 36
|
-8.1 percent change
Standard Deviation 10.2
|
-68.4 percent change
Standard Deviation 13.9
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 64
|
-18.0 percent change
Standard Deviation 15.5
|
-63.5 percent change
Standard Deviation 14.0
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 78
|
-12.3 percent change
Standard Deviation 12.2
|
-51.1 percent change
Standard Deviation 14.5
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 92
|
-6.6 percent change
Standard Deviation 14.5
|
-38.9 percent change
Standard Deviation 15.7
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 120
|
-12.4 percent change
Standard Deviation 7.7
|
-22.1 percent change
Standard Deviation 14.9
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 141
|
-14.3 percent change
Standard Deviation 17.4
|
-22.3 percent change
Standard Deviation 19.8
|
|
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Percent Change From Baseline at Day 3
|
-6.6 percent change
Standard Deviation 9.5
|
-10.3 percent change
Standard Deviation 16.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ISIS 757456
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants received ISIS 757456-matching placebo, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
ISIS 757456
n=18 participants at risk
Participants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
11.1%
2/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
11.1%
2/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chills
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritis
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Injection site rash
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Confusion
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Genitourinary symptom
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.5%
1/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
5.6%
1/18 • From signing of informed consent up to end of post-treatment period (Day 141)
Safety set included all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER