Trial Outcomes & Findings for Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) (NCT NCT03883607)
NCT ID: NCT03883607
Last Updated: 2021-10-28
Results Overview
Cmax was defined as maximum observed plasma concentration.
TERMINATED
PHASE2
10 participants
Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administration
2021-10-28
Participant Flow
The study was conducted at 2 centers in the United Sates from 25 June 2019 and 16 June 2020. A total of 27 participants were screened, of which 10 participants were enrolled and randomized (1:1 ratio) to receive elafibranor 80 milligrams (mg)/120 mg sequentially. A total of 17 participants failed screening mainly due to not meeting eligibility criteria.
Screening was performed up to 4 weeks before study drug administered. Randomization was stratified by age (Cohort 1: greater than or equal to \[\>=\] 12 to less than or equal to \[\<=\] 17 years of age and Cohort 2: \>=8 to \<=11 years of age) and participant's historical fibrosis severity stage (stratum 1: fibrosis stage 0 to 1 and stratum 2: fibrosis stage 2 to 3). Due to lack of efficacy study was prematurely terminated, only Cohort 1 participants were involved in this study.
Participant milestones
| Measure |
Elafibranor 80 mg
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.52 years
STANDARD_DEVIATION 2.23 • n=5 Participants
|
15.70 years
STANDARD_DEVIATION 2.31 • n=7 Participants
|
15.11 years
STANDARD_DEVIATION 2.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administrationPopulation: Analysis was performed on PK population that included all participants who had received at least 1 dose of the study drug, did not had protocol deviations or adverse events (AEs) that significantly affected the PK, and had at least 1 post-dose PK sample.
Cmax was defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007)
Elafibranor
|
385.216 nanograms per milliliter (ng/mL)
Standard Deviation 218.646
|
658.054 nanograms per milliliter (ng/mL)
Standard Deviation 403.201
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Elafibranor and Its Active Metabolite (GFT1007)
GFT1007
|
2367.620 nanograms per milliliter (ng/mL)
Standard Deviation 1088.123
|
2875.280 nanograms per milliliter (ng/mL)
Standard Deviation 1443.324
|
PRIMARY outcome
Timeframe: Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administrationPopulation: Analysis was performed on PK population.
Tmax was defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of Elafibranor and Active Metabolite (GFT1007)
Elafibranor
|
1.50 hours
Interval 0.52 to 2.0
|
1.00 hours
Interval 0.98 to 1.5
|
|
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of Elafibranor and Active Metabolite (GFT1007)
GFT1007
|
2.00 hours
Interval 1.5 to 2.0
|
1.50 hours
Interval 1.0 to 1.5
|
PRIMARY outcome
Timeframe: Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administrationPopulation: Analysis was performed on PK population.
AUC0-24 defined as the area under the plasma concentration versus time curve of the study drug from time 0 to 24 hours.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics: Area Under The Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Elafibranor and Active Metabolite (GFT1007)
Elafibranor
|
973.301 nanograms*hour per milliliter
Standard Deviation 311.803
|
1457.728 nanograms*hour per milliliter
Standard Deviation 724.018
|
|
Pharmacokinetics: Area Under The Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Elafibranor and Active Metabolite (GFT1007)
GFT1007
|
10011.405 nanograms*hour per milliliter
Standard Deviation 3575.220
|
10532.930 nanograms*hour per milliliter
Standard Deviation 3257.220
|
PRIMARY outcome
Timeframe: Day 1: at pre-dose; Day 29: at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours post dose; Day 30 and 85: at 24 hours after previous day dose administrationPopulation: Analysis was performed on PK population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
Plasma t1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics: Terminal Elimination Half-life ( t½) of Elafibranor and Active Metabolite (GFT1007)
Elafibranor
|
34.170 hours
Standard Deviation NA
Since one participant was evaluated, standard deviation (SD) was not calculable.
|
37.620 hours
Standard Deviation 15.473
|
|
Pharmacokinetics: Terminal Elimination Half-life ( t½) of Elafibranor and Active Metabolite (GFT1007)
GFT1007
|
9.572 hours
Standard Deviation 5.592
|
6.682 hours
Standard Deviation 1.120
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and 29Population: Analysis was performed on PK population.
Ctrough was defined as the plasma concentration of study drug observed just before treatment administration during repeated dosing.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics: Plasma Trough Concentrations (Ctrough) of Elafibranor and Active Metabolite (GFT1007)
GFT1007
|
97.771 ng/mL
Standard Deviation 49.636
|
55.243 ng/mL
Standard Deviation 27.769
|
|
Pharmacokinetics: Plasma Trough Concentrations (Ctrough) of Elafibranor and Active Metabolite (GFT1007)
Elafibranor
|
14.904 ng/mL
Standard Deviation 3.516
|
29.035 ng/mL
Standard Deviation 15.087
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis. Normal range at screening: AST: 0 - 39 international units per liter (IU/L), ALT: 5 - 30 IU/L, GGT: 2 - 24 IU/L, and ALP: 74 - 390 IU/L.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALT: Day 15
|
4.2 IU/L
Standard Deviation 21.7
|
-13.8 IU/L
Standard Deviation 25.0
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALT: Day 29
|
-0.2 IU/L
Standard Deviation 35.9
|
-27.6 IU/L
Standard Deviation 18.4
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALT: Day 57
|
0.2 IU/L
Standard Deviation 27.3
|
-30.8 IU/L
Standard Deviation 16.5
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALT: Day 85
|
17.8 IU/L
Standard Deviation 56.6
|
-34.6 IU/L
Standard Deviation 25.6
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALT: Day 113
|
37.3 IU/L
Standard Deviation 46.9
|
-28.0 IU/L
Standard Deviation 22.2
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
AST: Day 15
|
4.0 IU/L
Standard Deviation 16.0
|
0.8 IU/L
Standard Deviation 9.5
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
AST: Day 29
|
4.0 IU/L
Standard Deviation 16.3
|
-4.0 IU/L
Standard Deviation 9.5
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
AST: Day 57
|
1.0 IU/L
Standard Deviation 6.1
|
-5.8 IU/L
Standard Deviation 4.1
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
AST: Day 85
|
7.4 IU/L
Standard Deviation 15.3
|
-8.2 IU/L
Standard Deviation 8.3
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
AST: Day 113
|
9.3 IU/L
Standard Deviation 8.4
|
-7.8 IU/L
Standard Deviation 8.7
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
GGT: Day 15
|
-9.2 IU/L
Standard Deviation 6.8
|
-8.8 IU/L
Standard Deviation 4.4
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
GGT: Day 29
|
-15.6 IU/L
Standard Deviation 9.9
|
-16.0 IU/L
Standard Deviation 5.9
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
GGT: Day 57
|
-1.0 IU/L
Standard Deviation 20.7
|
-15.6 IU/L
Standard Deviation 9.1
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
GGT: Day 85
|
11.2 IU/L
Standard Deviation 39.1
|
-16.2 IU/L
Standard Deviation 9.9
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
GGT: Day 113
|
45.3 IU/L
Standard Deviation 43.8
|
-9.5 IU/L
Standard Deviation 6.6
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALP: Day 15
|
-4.6 IU/L
Standard Deviation 23.1
|
-18.0 IU/L
Standard Deviation 11.2
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALP: Day 29
|
-24.8 IU/L
Standard Deviation 28.4
|
-14.6 IU/L
Standard Deviation 8.1
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALP: Day 57
|
-28.2 IU/L
Standard Deviation 36.5
|
-18.4 IU/L
Standard Deviation 8.2
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALP: Day 85
|
-32.6 IU/L
Standard Deviation 51.5
|
-25.0 IU/L
Standard Deviation 12.4
|
|
Pharmacodynamics (PD) - Liver Markers: Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Alkaline Phosphatase (ALP) at Days 15, 29, 57, 85, and 113
ALP: Day 113
|
-7.8 IU/L
Standard Deviation 45.4
|
-16.8 IU/L
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Adiponectin at Days 29, 57, 85, and 113
Day 29
|
0.2410 micrograms per milliliter (mcg/mL)
Standard Deviation 0.3729
|
0.2112 micrograms per milliliter (mcg/mL)
Standard Deviation 1.0304
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Adiponectin at Days 29, 57, 85, and 113
Day 57
|
0.5780 micrograms per milliliter (mcg/mL)
Standard Deviation 1.0530
|
-0.2752 micrograms per milliliter (mcg/mL)
Standard Deviation 1.0022
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Adiponectin at Days 29, 57, 85, and 113
Day 85
|
0.3372 micrograms per milliliter (mcg/mL)
Standard Deviation 1.4844
|
-0.0590 micrograms per milliliter (mcg/mL)
Standard Deviation 1.0476
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Adiponectin at Days 29, 57, 85, and 113
Day 113
|
-0.4663 micrograms per milliliter (mcg/mL)
Standard Deviation 0.8972
|
0.0322 micrograms per milliliter (mcg/mL)
Standard Deviation 1.0588
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M65: Day 29
|
39.412 IU/L
Standard Deviation 346.370
|
-70.902 IU/L
Standard Deviation 121.905
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M65: Day 57
|
-30.302 IU/L
Standard Deviation 326.632
|
-60.578 IU/L
Standard Deviation 186.165
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M65: Day 85
|
-2.320 IU/L
Standard Deviation 231.775
|
-122.070 IU/L
Standard Deviation 265.059
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M65: Day 113
|
235.205 IU/L
Standard Deviation 290.846
|
-188.638 IU/L
Standard Deviation 244.324
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M30: Day 29
|
-24.282 IU/L
Standard Deviation 374.146
|
-68.896 IU/L
Standard Deviation 96.850
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M30: Day 57
|
7.530 IU/L
Standard Deviation 445.509
|
-20.074 IU/L
Standard Deviation 219.782
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M30: Day 85
|
-54.988 IU/L
Standard Deviation 315.261
|
-81.492 IU/L
Standard Deviation 271.506
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Cytokeratin 18 (CK-18)/M65 and CK-18/M30 at Days 29, 57, 85, and 113
CK-18/M30: Day 113
|
146.412 IU/L
Standard Deviation 273.673
|
-170.793 IU/L
Standard Deviation 235.722
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Ferritin at Days 29, 57, 85, and 113
Day 85
|
11.8 micrograms per liter (mcg/L)
Standard Deviation 16.6
|
-4.0 micrograms per liter (mcg/L)
Standard Deviation 2.4
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Ferritin at Days 29, 57, 85, and 113
Day 29
|
6.4 micrograms per liter (mcg/L)
Standard Deviation 12.0
|
10.8 micrograms per liter (mcg/L)
Standard Deviation 25.9
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Ferritin at Days 29, 57, 85, and 113
Day 57
|
19.4 micrograms per liter (mcg/L)
Standard Deviation 23.5
|
3.6 micrograms per liter (mcg/L)
Standard Deviation 15.6
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Ferritin at Days 29, 57, 85, and 113
Day 113
|
6.0 micrograms per liter (mcg/L)
Standard Deviation 5.7
|
-12.8 micrograms per liter (mcg/L)
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 19: Day 29
|
-24.4 picograms per milliliter (pg/mL)
Standard Deviation 80.6
|
-42.8 picograms per milliliter (pg/mL)
Standard Deviation 78.0
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 19: Day 57
|
-10.4 picograms per milliliter (pg/mL)
Standard Deviation 51.2
|
-18.8 picograms per milliliter (pg/mL)
Standard Deviation 85.3
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 19: Day 85
|
28.4 picograms per milliliter (pg/mL)
Standard Deviation 77.5
|
-13.0 picograms per milliliter (pg/mL)
Standard Deviation 100.6
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 19: Day 113
|
-7.8 picograms per milliliter (pg/mL)
Standard Deviation 61.3
|
-19.8 picograms per milliliter (pg/mL)
Standard Deviation 35.3
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 21: Day 29
|
9.98 picograms per milliliter (pg/mL)
Standard Deviation 91.38
|
128.84 picograms per milliliter (pg/mL)
Standard Deviation 171.50
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 21: Day 57
|
-36.36 picograms per milliliter (pg/mL)
Standard Deviation 188.91
|
195.94 picograms per milliliter (pg/mL)
Standard Deviation 315.73
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 21: Day 85
|
120.68 picograms per milliliter (pg/mL)
Standard Deviation 191.62
|
81.56 picograms per milliliter (pg/mL)
Standard Deviation 130.68
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Fibroblast Growth Factor 19 and Fibroblast Growth Factor 21 at Days 29, 57, 85, and 113
Fibroblast Growth Factor 21: Day 113
|
3.50 picograms per milliliter (pg/mL)
Standard Deviation 291.41
|
56.35 picograms per milliliter (pg/mL)
Standard Deviation 87.53
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Hyaluronic Acid: Day 29
|
-2.958 nanograms per milliliter (ng/mL)
Standard Deviation 11.689
|
-8.800 nanograms per milliliter (ng/mL)
Standard Deviation 10.991
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Hyaluronic Acid: Day 57
|
-0.272 nanograms per milliliter (ng/mL)
Standard Deviation 9.228
|
-3.654 nanograms per milliliter (ng/mL)
Standard Deviation 10.528
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Hyaluronic Acid: Day 85
|
4.408 nanograms per milliliter (ng/mL)
Standard Deviation 16.612
|
-3.518 nanograms per milliliter (ng/mL)
Standard Deviation 15.130
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Hyaluronic Acid: Day 113
|
1.592 nanograms per milliliter (ng/mL)
Standard Deviation 16.445
|
-0.422 nanograms per milliliter (ng/mL)
Standard Deviation 19.347
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Procollagen 3 N-Terminal Propeptide: Day 29
|
-3.018 nanograms per milliliter (ng/mL)
Standard Deviation 14.079
|
-2.878 nanograms per milliliter (ng/mL)
Standard Deviation 3.138
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Procollagen 3 N-Terminal Propeptide: Day 57
|
1.730 nanograms per milliliter (ng/mL)
Standard Deviation 6.928
|
-2.762 nanograms per milliliter (ng/mL)
Standard Deviation 3.242
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Procollagen 3 N-Terminal Propeptide: Day 85
|
-1.710 nanograms per milliliter (ng/mL)
Standard Deviation 6.730
|
-0.470 nanograms per milliliter (ng/mL)
Standard Deviation 5.270
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Procollagen 3 N-Terminal Propeptide: Day 113
|
-7.015 nanograms per milliliter (ng/mL)
Standard Deviation 11.902
|
-0.530 nanograms per milliliter (ng/mL)
Standard Deviation 3.701
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Tissue Inhibitor of Metalloproteinase 1: Day 29
|
-3.56 nanograms per milliliter (ng/mL)
Standard Deviation 25.38
|
-8.52 nanograms per milliliter (ng/mL)
Standard Deviation 8.98
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Tissue Inhibitor of Metalloproteinase 1: Day 57
|
2.80 nanograms per milliliter (ng/mL)
Standard Deviation 15.35
|
-26.20 nanograms per milliliter (ng/mL)
Standard Deviation 32.29
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Tissue Inhibitor of Metalloproteinase 1: Day 85
|
16.02 nanograms per milliliter (ng/mL)
Standard Deviation 24.84
|
-26.26 nanograms per milliliter (ng/mL)
Standard Deviation 25.43
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Hyaluronic Acid, Procollagen 3 N-Terminal Propeptide (PIIINP) and Tissue Inhibitor of Metalloproteinase 1 (TIMP1) at Days 29, 57, 85, and 113
Tissue Inhibitor of Metalloproteinase 1: Day 113
|
10.92 nanograms per milliliter (ng/mL)
Standard Deviation 21.58
|
-31.35 nanograms per milliliter (ng/mL)
Standard Deviation 37.95
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Alpha-2 Macroglobulin at Days 29, 57, 85, and 113
Day 57
|
0.124 gram per liter (g/L)
Standard Deviation 0.213
|
-0.118 gram per liter (g/L)
Standard Deviation 0.064
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Alpha-2 Macroglobulin at Days 29, 57, 85, and 113
Day 29
|
-0.098 gram per liter (g/L)
Standard Deviation 0.254
|
-0.282 gram per liter (g/L)
Standard Deviation 0.133
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Alpha-2 Macroglobulin at Days 29, 57, 85, and 113
Day 85
|
-0.030 gram per liter (g/L)
Standard Deviation 0.328
|
-0.204 gram per liter (g/L)
Standard Deviation 0.129
|
|
Pharmacodynamics - Other Liver Markers: Change From Baseline in Alpha-2 Macroglobulin at Days 29, 57, 85, and 113
Day 113
|
-0.105 gram per liter (g/L)
Standard Deviation 0.319
|
-0.037 gram per liter (g/L)
Standard Deviation 0.157
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Plasma Glucose (FPG) at Days 15, 29, 57, 85, and 113
Day 15
|
0.22 millimoles per liter (mmol/L)
Standard Deviation 0.34
|
0.22 millimoles per liter (mmol/L)
Standard Deviation 0.28
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Plasma Glucose (FPG) at Days 15, 29, 57, 85, and 113
Day 29
|
0.34 millimoles per liter (mmol/L)
Standard Deviation 0.61
|
0.12 millimoles per liter (mmol/L)
Standard Deviation 0.47
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Plasma Glucose (FPG) at Days 15, 29, 57, 85, and 113
Day 57
|
0.18 millimoles per liter (mmol/L)
Standard Deviation 0.58
|
0.10 millimoles per liter (mmol/L)
Standard Deviation 0.24
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Plasma Glucose (FPG) at Days 15, 29, 57, 85, and 113
Day 85
|
0.28 millimoles per liter (mmol/L)
Standard Deviation 0.63
|
0.08 millimoles per liter (mmol/L)
Standard Deviation 0.45
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Plasma Glucose (FPG) at Days 15, 29, 57, 85, and 113
Day 113
|
0.58 millimoles per liter (mmol/L)
Standard Deviation 0.52
|
0.17 millimoles per liter (mmol/L)
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (micro international units per milliliter \[mcIU/mL\]) \* fasting plasma glucose (mmol/L) / 22.5. A higher value indicates a greater insulin resistance. Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Days 15, 29, 57, 85, and 113
Day 15
|
10.720 Insulin resistance
Standard Deviation 17.650
|
-3.640 Insulin resistance
Standard Deviation 5.215
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Days 15, 29, 57, 85, and 113
Day 29
|
16.498 Insulin resistance
Standard Deviation 43.577
|
-4.028 Insulin resistance
Standard Deviation 6.512
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Days 15, 29, 57, 85, and 113
Day 57
|
4.958 Insulin resistance
Standard Deviation 15.472
|
-5.448 Insulin resistance
Standard Deviation 3.572
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Days 15, 29, 57, 85, and 113
Day 85
|
3.742 Insulin resistance
Standard Deviation 6.853
|
-1.968 Insulin resistance
Standard Deviation 7.112
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Days 15, 29, 57, 85, and 113
Day 113
|
13.323 Insulin resistance
Standard Deviation 22.795
|
-4.623 Insulin resistance
Standard Deviation 6.883
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "mIU/L" was abbreviated as "milli-international unit per liter".
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Insulin at Days 15, 29, 57, 85, and 113
Day 15
|
30.88 mIU/L
Standard Deviation 53.53
|
-15.66 mIU/L
Standard Deviation 20.92
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Insulin at Days 15, 29, 57, 85, and 113
Day 29
|
40.12 mIU/L
Standard Deviation 116.20
|
-16.76 mIU/L
Standard Deviation 24.12
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Insulin at Days 15, 29, 57, 85, and 113
Day 57
|
12.42 mIU/L
Standard Deviation 41.76
|
-23.10 mIU/L
Standard Deviation 12.58
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Insulin at Days 15, 29, 57, 85, and 113
Day 85
|
9.70 mIU/L
Standard Deviation 15.49
|
-7.48 mIU/L
Standard Deviation 26.76
|
|
Pharmacodynamics - Glucose Homeostasis Markers: Change From Baseline in Fasting Insulin at Days 15, 29, 57, 85, and 113
Day 113
|
34.15 mIU/L
Standard Deviation 58.20
|
-19.57 mIU/L
Standard Deviation 25.56
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Total Cholesterol (TC) at Days 15, 29, 57, 85, and 113
Day 15
|
-0.070 mmol/L
Standard Deviation 0.440
|
-0.328 mmol/L
Standard Deviation 0.230
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Total Cholesterol (TC) at Days 15, 29, 57, 85, and 113
Day 29
|
-0.356 mmol/L
Standard Deviation 0.252
|
-0.288 mmol/L
Standard Deviation 0.347
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Total Cholesterol (TC) at Days 15, 29, 57, 85, and 113
Day 57
|
0.380 mmol/L
Standard Deviation 0.565
|
-0.286 mmol/L
Standard Deviation 0.129
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Total Cholesterol (TC) at Days 15, 29, 57, 85, and 113
Day 85
|
0.298 mmol/L
Standard Deviation 0.836
|
-0.274 mmol/L
Standard Deviation 0.306
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Total Cholesterol (TC) at Days 15, 29, 57, 85, and 113
Day 113
|
0.665 mmol/L
Standard Deviation 0.919
|
0.105 mmol/L
Standard Deviation 0.270
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Non High-density Lipoprotein Cholesterol (Non-HDL-C) at Days 15, 29, 57, 85, and 113
Day 15
|
-0.134 mmol/L
Standard Deviation 0.414
|
-0.348 mmol/L
Standard Deviation 0.163
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Non High-density Lipoprotein Cholesterol (Non-HDL-C) at Days 15, 29, 57, 85, and 113
Day 29
|
-0.324 mmol/L
Standard Deviation 0.196
|
-0.316 mmol/L
Standard Deviation 0.432
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Non High-density Lipoprotein Cholesterol (Non-HDL-C) at Days 15, 29, 57, 85, and 113
Day 57
|
0.368 mmol/L
Standard Deviation 0.340
|
-0.316 mmol/L
Standard Deviation 0.194
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Non High-density Lipoprotein Cholesterol (Non-HDL-C) at Days 15, 29, 57, 85, and 113
Day 85
|
0.156 mmol/L
Standard Deviation 0.615
|
-0.420 mmol/L
Standard Deviation 0.290
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Non High-density Lipoprotein Cholesterol (Non-HDL-C) at Days 15, 29, 57, 85, and 113
Day 113
|
0.605 mmol/L
Standard Deviation 0.714
|
-0.038 mmol/L
Standard Deviation 0.229
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum High-density Lipoprotein Cholesterol (HDL-C) at Days 15, 29, 57, 85, and 113
Day 15
|
0.060 mmol/L
Standard Deviation 0.068
|
0.020 mmol/L
Standard Deviation 0.223
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum High-density Lipoprotein Cholesterol (HDL-C) at Days 15, 29, 57, 85, and 113
Day 29
|
-0.032 mmol/L
Standard Deviation 0.124
|
0.032 mmol/L
Standard Deviation 0.137
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum High-density Lipoprotein Cholesterol (HDL-C) at Days 15, 29, 57, 85, and 113
Day 57
|
0.008 mmol/L
Standard Deviation 0.228
|
0.030 mmol/L
Standard Deviation 0.168
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum High-density Lipoprotein Cholesterol (HDL-C) at Days 15, 29, 57, 85, and 113
Day 85
|
0.138 mmol/L
Standard Deviation 0.278
|
0.150 mmol/L
Standard Deviation 0.191
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum High-density Lipoprotein Cholesterol (HDL-C) at Days 15, 29, 57, 85, and 113
Day 113
|
0.065 mmol/L
Standard Deviation 0.259
|
0.150 mmol/L
Standard Deviation 0.047
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific time points.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Low-density Lipoprotein (LDL-C) at Days 15, 29, 57, 85, and 113
Day 15
|
-0.224 mmol/L
Standard Deviation 0.365
|
-0.084 mmol/L
Standard Deviation 0.213
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Low-density Lipoprotein (LDL-C) at Days 15, 29, 57, 85, and 113
Day 29
|
-0.344 mmol/L
Standard Deviation 0.184
|
-0.076 mmol/L
Standard Deviation 0.355
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Low-density Lipoprotein (LDL-C) at Days 15, 29, 57, 85, and 113
Day 57
|
0.314 mmol/L
Standard Deviation 0.355
|
-0.038 mmol/L
Standard Deviation 0.078
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Low-density Lipoprotein (LDL-C) at Days 15, 29, 57, 85, and 113
Day 85
|
0.080 mmol/L
Standard Deviation 0.686
|
-0.184 mmol/L
Standard Deviation 0.223
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Low-density Lipoprotein (LDL-C) at Days 15, 29, 57, 85, and 113
Day 113
|
0.385 mmol/L
Standard Deviation 0.691
|
0.108 mmol/L
Standard Deviation 0.134
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Triglycerides at Days 15, 29, 57, 85, and 113
Day 15
|
0.200 mmol/L
Standard Deviation 0.363
|
-0.576 mmol/L
Standard Deviation 0.442
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Triglycerides at Days 15, 29, 57, 85, and 113
Day 29
|
0.042 mmol/L
Standard Deviation 0.214
|
-0.530 mmol/L
Standard Deviation 0.385
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Triglycerides at Days 15, 29, 57, 85, and 113
Day 57
|
0.124 mmol/L
Standard Deviation 0.326
|
-0.606 mmol/L
Standard Deviation 0.384
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Triglycerides at Days 15, 29, 57, 85, and 113
Day 85
|
0.170 mmol/L
Standard Deviation 0.389
|
-0.532 mmol/L
Standard Deviation 0.399
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Triglycerides at Days 15, 29, 57, 85, and 113
Day 113
|
0.485 mmol/L
Standard Deviation 0.918
|
-0.315 mmol/L
Standard Deviation 0.353
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Calculated Very Low-density Lipoprotein Cholesterol (VLDL-C) at Days 15, 29, 57, 85, and 113
Day 15
|
0.086 mmol/L
Standard Deviation 0.172
|
-0.270 mmol/L
Standard Deviation 0.200
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Calculated Very Low-density Lipoprotein Cholesterol (VLDL-C) at Days 15, 29, 57, 85, and 113
Day 29
|
0.018 mmol/L
Standard Deviation 0.103
|
-0.244 mmol/L
Standard Deviation 0.168
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Calculated Very Low-density Lipoprotein Cholesterol (VLDL-C) at Days 15, 29, 57, 85, and 113
Day 57
|
0.052 mmol/L
Standard Deviation 0.140
|
-0.282 mmol/L
Standard Deviation 0.176
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Calculated Very Low-density Lipoprotein Cholesterol (VLDL-C) at Days 15, 29, 57, 85, and 113
Day 85
|
0.072 mmol/L
Standard Deviation 0.168
|
-0.240 mmol/L
Standard Deviation 0.176
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Calculated Very Low-density Lipoprotein Cholesterol (VLDL-C) at Days 15, 29, 57, 85, and 113
Day 113
|
0.215 mmol/L
Standard Deviation 0.419
|
-0.153 mmol/L
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein A-1 at Days 15, 29, 57, 85, and 113
Day 15
|
0.112 grams per liter (g/L)
Standard Deviation 0.129
|
-0.058 grams per liter (g/L)
Standard Deviation 0.149
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein A-1 at Days 15, 29, 57, 85, and 113
Day 29
|
0.012 grams per liter (g/L)
Standard Deviation 0.139
|
-0.058 grams per liter (g/L)
Standard Deviation 0.144
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein A-1 at Days 15, 29, 57, 85, and 113
Day 57
|
0.108 grams per liter (g/L)
Standard Deviation 0.211
|
-0.060 grams per liter (g/L)
Standard Deviation 0.176
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein A-1 at Days 15, 29, 57, 85, and 113
Day 85
|
0.128 grams per liter (g/L)
Standard Deviation 0.268
|
0.016 grams per liter (g/L)
Standard Deviation 0.160
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein A-1 at Days 15, 29, 57, 85, and 113
Day 113
|
0.103 grams per liter (g/L)
Standard Deviation 0.313
|
0.048 grams per liter (g/L)
Standard Deviation 0.060
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein B at Days 15, 29, 57, 85, and 113
Day 29
|
-0.098 g/L
Standard Deviation 0.081
|
-0.078 g/L
Standard Deviation 0.097
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein B at Days 15, 29, 57, 85, and 113
Day 57
|
0.066 g/L
Standard Deviation 0.092
|
-0.062 g/L
Standard Deviation 0.086
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein B at Days 15, 29, 57, 85, and 113
Day 15
|
-0.058 g/L
Standard Deviation 0.064
|
-0.082 g/L
Standard Deviation 0.074
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein B at Days 15, 29, 57, 85, and 113
Day 85
|
0.020 g/L
Standard Deviation 0.189
|
-0.036 g/L
Standard Deviation 0.090
|
|
Pharmacodynamics - Serum Lipid Parameters: Change From Baseline in Serum Apolipoprotein B at Days 15, 29, 57, 85, and 113
Day 113
|
0.117 g/L
Standard Deviation 0.209
|
-0.005 g/L
Standard Deviation 0.135
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Change From Baseline in Body Weight at Days 15, 29, 57, 85, and 113
Day 15
|
-0.08 kilograms (kg)
Standard Deviation 3.03
|
-0.92 kilograms (kg)
Standard Deviation 1.70
|
|
Pharmacodynamics - Change From Baseline in Body Weight at Days 15, 29, 57, 85, and 113
Day 29
|
-0.32 kilograms (kg)
Standard Deviation 4.54
|
-0.98 kilograms (kg)
Standard Deviation 2.06
|
|
Pharmacodynamics - Change From Baseline in Body Weight at Days 15, 29, 57, 85, and 113
Day 57
|
0.73 kilograms (kg)
Standard Deviation 5.18
|
-0.68 kilograms (kg)
Standard Deviation 3.27
|
|
Pharmacodynamics - Change From Baseline in Body Weight at Days 15, 29, 57, 85, and 113
Day 85
|
1.54 kilograms (kg)
Standard Deviation 5.42
|
0.24 kilograms (kg)
Standard Deviation 4.07
|
|
Pharmacodynamics - Change From Baseline in Body Weight at Days 15, 29, 57, 85, and 113
Day 113
|
4.40 kilograms (kg)
Standard Deviation 3.05
|
0.73 kilograms (kg)
Standard Deviation 4.63
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
The BMI for a given age (in years) and gender (male) was converted to an exact z-score. Given a participant's age, sex, BMI, and an appropriate reference standard, a BMI Z-score was determined. BMI Z-score \>=85th percentile was considered as overweight. Z-score was a statistical measure to describe whether a mean was above or below the standard. A Z-score of 0 was equal to the mean and is considered normal. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Negative values are indicative of decrease in BMI (weight loss) and positive values are indicative of increase in BMI. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Change From Baseline in Body Mass Index (BMI) Z-Score at Days 15, 29, 57, 85, and 113
Day 15
|
-0.064 Z-Score
Standard Deviation 0.146
|
-0.054 Z-Score
Standard Deviation 0.095
|
|
Pharmacodynamics - Change From Baseline in Body Mass Index (BMI) Z-Score at Days 15, 29, 57, 85, and 113
Day 29
|
-0.091 Z-Score
Standard Deviation 0.247
|
-0.054 Z-Score
Standard Deviation 0.110
|
|
Pharmacodynamics - Change From Baseline in Body Mass Index (BMI) Z-Score at Days 15, 29, 57, 85, and 113
Day 57
|
-0.108 Z-Score
Standard Deviation 0.284
|
-0.058 Z-Score
Standard Deviation 0.162
|
|
Pharmacodynamics - Change From Baseline in Body Mass Index (BMI) Z-Score at Days 15, 29, 57, 85, and 113
Day 85
|
-0.074 Z-Score
Standard Deviation 0.290
|
-0.026 Z-Score
Standard Deviation 0.197
|
|
Pharmacodynamics - Change From Baseline in Body Mass Index (BMI) Z-Score at Days 15, 29, 57, 85, and 113
Day 113
|
0.068 Z-Score
Standard Deviation 0.116
|
0.022 Z-Score
Standard Deviation 0.247
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Waist circumference (in centimeters \[cm\]) was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Change From Baseline in Waist Circumference at Days 15, 29, 57, 85, and 113
Day 15
|
-1.056 cm
Standard Deviation 2.953
|
-0.998 cm
Standard Deviation 2.961
|
|
Pharmacodynamics - Change From Baseline in Waist Circumference at Days 15, 29, 57, 85, and 113
Day 29
|
-0.656 cm
Standard Deviation 3.654
|
-2.010 cm
Standard Deviation 2.625
|
|
Pharmacodynamics - Change From Baseline in Waist Circumference at Days 15, 29, 57, 85, and 113
Day 57
|
-0.316 cm
Standard Deviation 3.520
|
-2.054 cm
Standard Deviation 4.106
|
|
Pharmacodynamics - Change From Baseline in Waist Circumference at Days 15, 29, 57, 85, and 113
Day 85
|
0.252 cm
Standard Deviation 3.379
|
-1.346 cm
Standard Deviation 3.894
|
|
Pharmacodynamics - Change From Baseline in Waist Circumference at Days 15, 29, 57, 85, and 113
Day 113
|
1.625 cm
Standard Deviation 2.394
|
-0.580 cm
Standard Deviation 4.099
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples to assess fibrinogen levels were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Fibrinogen at Days 29, 57, 85, and 113
Day 29
|
-1.450 micromoles per liter (mcmol/L)
Standard Deviation 1.265
|
-2.474 micromoles per liter (mcmol/L)
Standard Deviation 1.418
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Fibrinogen at Days 29, 57, 85, and 113
Day 57
|
-0.524 micromoles per liter (mcmol/L)
Standard Deviation 1.309
|
-2.220 micromoles per liter (mcmol/L)
Standard Deviation 0.756
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Fibrinogen at Days 29, 57, 85, and 113
Day 85
|
-1.340 micromoles per liter (mcmol/L)
Standard Deviation 1.492
|
-1.748 micromoles per liter (mcmol/L)
Standard Deviation 1.000
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Fibrinogen at Days 29, 57, 85, and 113
Day 113
|
-0.295 micromoles per liter (mcmol/L)
Standard Deviation 1.936
|
-1.150 micromoles per liter (mcmol/L)
Standard Deviation 1.841
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples to assess Haptoglobin level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Haptoglobin at Days 29, 57, 85, and 113
Day 29
|
-0.086 g/L
Standard Deviation 0.102
|
-0.350 g/L
Standard Deviation 0.244
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Haptoglobin at Days 29, 57, 85, and 113
Day 57
|
0.068 g/L
Standard Deviation 0.118
|
-0.300 g/L
Standard Deviation 0.209
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Haptoglobin at Days 29, 57, 85, and 113
Day 85
|
0.066 g/L
Standard Deviation 0.077
|
-0.298 g/L
Standard Deviation 0.236
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Haptoglobin at Days 29, 57, 85, and 113
Day 113
|
0.178 g/L
Standard Deviation 0.208
|
-0.058 g/L
Standard Deviation 0.081
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples to assess Interleukin-6 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Interleukin-6 at Days 29, 57, 85, and 113
Day 29
|
0.036 picograms per milliliter (pg/mL)
Standard Deviation 0.080
|
0.142 picograms per milliliter (pg/mL)
Standard Deviation 0.751
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Interleukin-6 at Days 29, 57, 85, and 113
Day 57
|
0.100 picograms per milliliter (pg/mL)
Standard Deviation 0.224
|
-0.092 picograms per milliliter (pg/mL)
Standard Deviation 1.096
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Interleukin-6 at Days 29, 57, 85, and 113
Day 85
|
0.142 picograms per milliliter (pg/mL)
Standard Deviation 0.243
|
0.062 picograms per milliliter (pg/mL)
Standard Deviation 0.809
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Interleukin-6 at Days 29, 57, 85, and 113
Day 113
|
0.143 picograms per milliliter (pg/mL)
Standard Deviation 0.285
|
0.078 picograms per milliliter (pg/mL)
Standard Deviation 0.534
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples to assess Necrosis Factor Alpha level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Tumor Necrosis Factor Alpha at Days 29, 57, 85, and 113
Day 29
|
-0.134 pg/mL
Standard Deviation 0.437
|
-0.460 pg/mL
Standard Deviation 0.857
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Tumor Necrosis Factor Alpha at Days 29, 57, 85, and 113
Day 57
|
0.068 pg/mL
Standard Deviation 0.388
|
-0.270 pg/mL
Standard Deviation 0.651
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Tumor Necrosis Factor Alpha at Days 29, 57, 85, and 113
Day 85
|
-0.068 pg/mL
Standard Deviation 0.416
|
-0.622 pg/mL
Standard Deviation 0.939
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Tumor Necrosis Factor Alpha at Days 29, 57, 85, and 113
Day 113
|
0.163 pg/mL
Standard Deviation 0.534
|
-0.445 pg/mL
Standard Deviation 0.988
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, 57, 85, and 113Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.
Blood samples to assess plasminogen activator inhibitor-1 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "IU/mL" was abbreviated as International units per milliliter.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Plasminogen Activator Inhibitor-1 at Days 29, 57, 85, and 113
Day 29
|
-8.95 IU/mL
Standard Deviation 14.19
|
-1.40 IU/mL
Standard Deviation 10.33
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Plasminogen Activator Inhibitor-1 at Days 29, 57, 85, and 113
Day 57
|
9.68 IU/mL
Standard Deviation 32.87
|
2.46 IU/mL
Standard Deviation 15.03
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Plasminogen Activator Inhibitor-1 at Days 29, 57, 85, and 113
Day 85
|
-2.43 IU/mL
Standard Deviation 7.57
|
2.62 IU/mL
Standard Deviation 23.77
|
|
Pharmacodynamics - Inflammatory Marker: Change From Baseline in Plasminogen Activator Inhibitor-1 at Days 29, 57, 85, and 113
Day 113
|
5.75 IU/mL
Standard Deviation 26.71
|
5.40 IU/mL
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 85Population: Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.
The child, adolescent and parent/legal guardian PedsQL™ (Version 4.0) generic core scales was used to measure health-related quality of life (HRQOL). The response information was completed by the participant and by a parent/legal guardian individually. It consisted of 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem to 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), where higher scores indicated better HRQOL. Total Scale Score was the sum of all the items over the number of items answered on all the Scales. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Pharmacodynamics - Change From Baseline in Pediatric Quality of Life (PedsQL™) (Version 4.0) Generic Core Scales at Day 85
Parent
|
-3.80 units on a scale
Standard Deviation 13.76
|
-13.04 units on a scale
Standard Deviation 11.32
|
|
Pharmacodynamics - Change From Baseline in Pediatric Quality of Life (PedsQL™) (Version 4.0) Generic Core Scales at Day 85
Participants
|
-3.04 units on a scale
Standard Deviation 1.42
|
-3.04 units on a scale
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: From Screening visit (signature of informed consent) up to last dose of study drug + 30 days (i.e., up to Day 113)Population: Analysis was performed safety population that included participants who had received at least one dose of study drug and had at least one post-baseline safety assessment.
An adverse event (AE) was any untoward medical in a participant or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was another medically important condition. TEAEs were defined as AEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. TEAEs: Serious and non-serious AEs.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 85Population: Analysis was performed safety population.
ECG measurements were taken with the participants in resting position for at least 10 minutes. The investigator determined whether abnormal assessment results were clinically significant or not. The number of participants with abnormal clinically significant ECG findings were reported. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Measurement
Baseline (Day1): Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Measurement
Day 85: Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 85 (i.e., end of treatment)Population: Analysis was performed on safety population.
Fasting blood samples (collected after 10 hours fasting) were used to assess the following clinical chemistry parameters: creatinine, glomerular filtration rate, creatinine clearance, total proteins, albumin, electrolytes (sodium, potassium, chloride, calcium), uric acid, urea nitrogen, urea, creatine phosphokinase (CPK), AST, ALT, GGT, ALP, total and conjugated bilirubin, high sensitivity C-reactive protein, fasting plasma glucose, fasting insulin, HOMA-IR, fructosamine, C-peptide, free fatty acids, glycated hemoglobin A1c, cystatin C. Abnormal clinical chemistry values were classified based on reference range: lower limit of normality (LLN); normal (\>= LLN and \<= upper limit of normality \[ULN\]); \> ULN and \<3 ULN; \>=3 ULN and \<5 ULN and \>=5 ULN. Only the parameters for which at least one value of abnormality were reported and presented in this outcome measure.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Total proteins: >ULN and <3 ULN
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Albumin: >ULN and <3 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
CPK: >ULN and <3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
AST: >ULN and <3 ULN
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
ALT: >ULN and <3 ULN
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
ALT: >=3 ULN and <5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
ALT: >=5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
GGT: >ULN and <3 ULN
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
GGT: >=3 ULN and <5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
GGT: >=5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
ALP: >ULN and <3 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Total Bilirubin: >ULN and <3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Conjugated Bilirubin: >ULN and <3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
C Reactive Protein: >ULN and <3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Fasting plasma glucose: >ULN and <3 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Fasting insulin: >ULN and <3 ULN
|
3 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Fasting insulin: >=3 ULN and <5 ULN
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
C-peptide: >ULN and <3 ULN
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Hemoglobin A1C: >ULN and <3 ULN
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 85 (i.e., end of treatment)Population: Analysis was performed on safety population.
Fasting blood samples (collected after 10 hours fasting) were used to assess the following hematology and coagulation parameters: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC), neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, prothrombin time (PT) and international normalized ratio (INR). Hematology and coagulation values were classified based on the reference range: LLN; normal (\>= LLN and \<= ULN); \> ULN and \<3 ULN; \>=3 ULN and \<5 ULN and \>=5 ULN.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Haemoglobin: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Hematocrit: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
RBC: >ULN and <3 ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
WBC: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Neutrophils: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Eosinophils: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Basophils: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Lymphocytes: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Monocytes: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
Platelets: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
PT: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology and Coagulation Parameters
INR: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 85 (i.e., end of treatment)Population: Analysis was performed on safety population.
Blood samples were collected to assess the following urinalysis parameters: alpha-1 macroglobulin, N-acetyl glucosamide, neutrophil gelatinase-associated lipocalin, albumin, and creatinine. Abnormal urinalysis values were classified based on the reference range: LLN; normal (\>= LLN and \<= ULN); \> ULN and \<3 ULN; \>=3 ULN and \<5 ULN and \>=5 ULN.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Urinalysis Parameters
Alpha-1 Microglobulin: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters
N-Acetyl Glucosamide: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters
Neutrophil Gelatinase-associated: >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters
Albumin: : >ULN and <3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters
Creatinine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 85 (i.e., end of treatment)Population: Analysis was performed on safety population.
Vital signs were taken before any invasive procedures. Following vital signs were assessed: systolic blood pressure, diastolic blood pressure, heart rate. Abnormal vita signs was defined as any abnormal findings in the vital sign parameters and were categorized as 'abnormal, not clinically significant (NCS)' and 'abnormal, clinically significant (CS)'.
Outcome measures
| Measure |
Elafibranor 80 mg
n=5 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs
Systolic Blood Pressure:Abnormal, not clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Systolic Blood Pressure: Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Diastolic Blood Pressure: Abnormal, not clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Diastolic Blood Pressure: Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Heart Rate: Abnormal, not clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Heart Rate: Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 15, 29, 57, 85, and 113Population: Analysis was performed on safety population. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
Physical examination findings were collected according to pre-defined body systems: general appearance; skin; eyes; ears; nose; throat; neck and thyroid; lungs; heart; upper/lower extremities; lymph nodes; abdomen; musculoskeletal system; basic neurological assessment. Additional systems were evaluated as needed. Clinical significance was defined as any variation in assessment results that had medical relevance resulting in an alteration in medical care. Participants with at least one clinically significant abnormality in physical examination were reported and presented in this outcome measure. Baseline was defined as the last measurement before first intake of study treatment on Day 1.
Outcome measures
| Measure |
Elafibranor 80 mg
n=4 Participants
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=2 Participants
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Baseline (Day 1)
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Day 15
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Day 29
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Day 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Day 85
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination at Baseline, Days 15, 29, 57, 85, and 113
Day 113
|
0 Participants
|
0 Participants
|
Adverse Events
Elafibranor 80 mg
Elafibranor 120 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elafibranor 80 mg
n=5 participants at risk
Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.
|
Elafibranor 120 mg
n=5 participants at risk
Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatomegaly
|
20.0%
1/5 • Number of events 1 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
0.00%
0/5 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis viral
|
20.0%
1/5 • Number of events 1 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
0.00%
0/5 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.0%
1/5 • Number of events 1 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
0.00%
0/5 • All AEs were collected from screening through 30 days after last dose of study drug (i.e., up to Day 113) regardless of seriousness or relationship to study drug.
Reported AEs were TEAEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor retains exclusive ownership of all data, results, reports, findings, discoveries, and any other information collected during this study; these may not be published, given, or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER