Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy (NCT NCT03193047)
NCT ID: NCT03193047
Last Updated: 2020-04-03
Results Overview
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline; Month 2
Results posted on
2020-04-03
Participant Flow
170 participants were screened; out of 170, 59 participants were randomized. One participant never received study medication and withdrew from the study due to the Sponsor's decision.
Participant milestones
| Measure |
Placebo Plus Evolocumab
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected once a month over 9 minutes as background therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
28
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo Plus Evolocumab
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected once a month over 9 minutes as background therapy.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Participant Left State
|
1
|
0
|
Baseline Characteristics
Only those participants with data available were analyzed.
Baseline characteristics by cohort
| Measure |
Placebo Plus Evolocumab
n=30 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=28 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 11.16 • n=30 Participants
|
62.0 years
STANDARD_DEVIATION 9.36 • n=28 Participants
|
60.1 years
STANDARD_DEVIATION 10.40 • n=58 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
21 Participants
n=28 Participants
|
36 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
7 Participants
n=28 Participants
|
22 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=30 Participants
|
4 Participants
n=28 Participants
|
6 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=30 Participants
|
24 Participants
n=28 Participants
|
52 Participants
n=58 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (L-DLC) Values
|
104.12 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 32.121 • n=30 Participants
|
102.09 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 28.982 • n=28 Participants
|
103.14 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 30.395 • n=58 Participants
|
|
Baseline Total Cholesterol (TC) and Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Values
TC
|
190.33 mg/dL
STANDARD_DEVIATION 39.387 • n=30 Participants
|
186.20 mg/dL
STANDARD_DEVIATION 38.343 • n=28 Participants
|
188.34 mg/dL
STANDARD_DEVIATION 38.601 • n=58 Participants
|
|
Baseline Total Cholesterol (TC) and Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Values
non-HDL-C
|
132.95 mg/dL
STANDARD_DEVIATION 36.599 • n=30 Participants
|
129.68 mg/dL
STANDARD_DEVIATION 36.301 • n=28 Participants
|
131.37 mg/dL
STANDARD_DEVIATION 36.172 • n=58 Participants
|
|
Baseline Apolipoprotein B (apoB) Values
|
87.9 mg/dL
STANDARD_DEVIATION 23.80 • n=28 Participants • Only those participants with data available were analyzed.
|
87.5 mg/dL
STANDARD_DEVIATION 27.13 • n=28 Participants • Only those participants with data available were analyzed.
|
87.7 mg/dL
STANDARD_DEVIATION 25.29 • n=56 Participants • Only those participants with data available were analyzed.
|
|
Baseline High-Sensitivity C-Reactive Protein (hs-CRP) Values
|
2.090 milligrams per Liter
n=29 Participants • Only those participants with data available were analyzed.
|
3.125 milligrams per Liter
n=28 Participants • Only those participants with data available were analyzed.
|
2.340 milligrams per Liter
n=57 Participants • Only those participants with data available were analyzed.
|
PRIMARY outcome
Timeframe: Baseline; Month 2Population: Modified Intent-to-Treat (mITT) Population: all randomized participants with a Baseline lipid value and at least 1 post-Baseline lipid value who received investigational medicinal product (IMP) within 2 days before the lipid measurement and evolocumab 420 mg within 30 days plus or minus 3 days before the lipid measurement
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=26 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=27 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
|
2.783 percent change
Standard Error 3.412
|
-27.478 percent change
Standard Error 4.310
|
SECONDARY outcome
Timeframe: Baseline; Month 1Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=25 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=26 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Month 1
|
3.172 percent change
Standard Error 2.700
|
-32.712 percent change
Standard Error 4.385
|
SECONDARY outcome
Timeframe: Baseline; Month 1 and Month 2Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=26 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=27 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Month 1
|
1.75 milligrams per deciliter (mg/dL)
Standard Error 3.118
|
-36.51 milligrams per deciliter (mg/dL)
Standard Error 46.41
|
|
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Month 2
|
-0.02 milligrams per deciliter (mg/dL)
Standard Error 3.386
|
-29.92 milligrams per deciliter (mg/dL)
Standard Error 4.461
|
SECONDARY outcome
Timeframe: Baseline; Month 1 and Month 2Population: mITT Population
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=26 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=27 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
apo-B at Month 1
|
0.547 percent change
Standard Error 2.948
|
-26.484 percent change
Standard Error 4.175
|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
non-HDL-C at Month 1
|
2.077 percent change
Standard Error 2.378
|
-29.563 percent change
Standard Error 4.031
|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
TC at Month 1
|
1.170 percent change
Standard Error 1.877
|
-20.770 percent change
Standard Error 3.025
|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
apo-B at Month 2
|
2.706 percent change
Standard Error 2.182
|
-21.763 percent change
Standard Error 3.736
|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
non-HDL-C at Month 2
|
1.285 percent change
Standard Error 2.783
|
-22.960 percent change
Standard Error 3.951
|
|
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
TC at Month 2
|
0.557 percent change
Standard Error 2.009
|
-16.963 percent change
Standard Error 3.228
|
SECONDARY outcome
Timeframe: Baseline; Month 1 and Month 2Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=26 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=27 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
hs-CRP at Month 1
|
10.658 percent change
Interval -36.488 to 66.374
|
-23.349 percent change
Interval -57.857 to 5.128
|
|
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
hs-CRP at Month 2
|
-1.623 percent change
Interval -39.445 to 26.531
|
-34.444 percent change
Interval -57.599 to -7.083
|
SECONDARY outcome
Timeframe: up to Month 2 (until 30 days after last dose)Population: Safety Population: all randomized participants who received at least 1 dose of IMP. Participants in the Safety Population were included in the treatment group that they received, regardless of their randomized treatment.
Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=30 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=28 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Any TEAE
|
7 Participants
|
9 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
TEAEs related to IMP
|
1 Participants
|
1 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
TEAEs related to evolocumab
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
TESAEs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
TESAEs related to IMP
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
TESAEs related to evolocumab
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Deaths
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Discontinuation of IMP due to TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Mild TEAEs
|
5 Participants
|
4 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Moderate TEAEs
|
2 Participants
|
4 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Severe TEAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 1 and Month 2Population: Safety Population. Only those participants with available data were analyzed.
The number of participants with ALT or AST \>3x ULN was measured.
Outcome measures
| Measure |
Placebo Plus Evolocumab
n=30 Participants
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=28 Participants
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
ALT, Month 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
ALT, Month 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
AST, Month 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
AST, Month 2
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo Plus Evolocumab
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bempedoic Acid Plus Evolocumab
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Plus Evolocumab
n=30 participants at risk
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=28 participants at risk
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
Other adverse events
| Measure |
Placebo Plus Evolocumab
n=30 participants at risk
Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy.
|
Bempedoic Acid Plus Evolocumab
n=28 participants at risk
Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy.
|
|---|---|---|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Reproductive system and breast disorders
Ejaculation failure
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
General disorders
Injection site reaction
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Infections and infestations
Pyelonephritis acute
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
3.6%
1/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
0.00%
0/28 • up to Month 2 (until 30 days after last dose)
Treatment-emergent adverse events (TEAEs) and serious TEAEs, defined as those events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were reported for the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
- Publication restrictions are in place
Restriction type: OTHER