Trial Outcomes & Findings for A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD (NCT NCT03763877)
NCT ID: NCT03763877
Last Updated: 2021-10-28
Results Overview
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-10-28
Participant Flow
Patients were screened for the study at 15 sites in the United States between 29Mar19 and 13Mar20.
Following a Screening period of maximum 2 weeks, eligible participants entered in a single-blind placebo Run-in period of 4 weeks. This Run-in period was set to reduce any bias regarding placebo effect, to assess patient compliance, and to minimize the possible confounding influence of dietary and activity changes. Only participants who have met all the applicable Inclusion criteria and none of the Exclusion criteria at the end the Run-in period were to be randomized.
Participant milestones
| Measure |
Placebo
Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning
* 2 capsules of placebo in the evening
|
PXL770 250 mg BID
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the evening
|
PXL770 500 mg QD
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 2 capsules of PXL770 250 mg
* 2 capsules of placebo in the evening
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
29
|
|
Overall Study
Received at Least 1 Dose of Double-blind Study Treatment
|
31
|
30
|
30
|
29
|
|
Overall Study
Completed the Double-blind Period
|
27
|
26
|
25
|
24
|
|
Overall Study
COMPLETED
|
26
|
26
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
7
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning
* 2 capsules of placebo in the evening
|
PXL770 250 mg BID
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning
* 1 capsule of PXL770 250 mg + 1 capsule of placebo in the evening
|
PXL770 500 mg QD
PXL770 250 mg: Oral capsule Placebo: Oral capsule
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:
* 2 capsules of PXL770 250 mg
* 2 capsules of placebo in the evening
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
3
|
4
|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID at least 15 minutes before a meal for 12 weeks
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 12.93 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 12.63 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 12.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
T2DM status (stratification group)
T2DM
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
T2DM status (stratification group)
Non-T2DM
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intent-to-treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)
|
-1.14 percentage
Standard Error 6.344
|
-1.03 percentage
Standard Error 6.764
|
-14.28 percentage
Standard Error 6.697
|
-14.68 percentage
Standard Error 6.452
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Per Protocol Set (PPS), defined as all patients in the ITTS who complete the double-blind treatment period and have an overall treatment duration ≥8 weeks (≥56 days) without any CSR reportable protocol deviations (PD) that is deemed to affect the primary efficacy endpoint of MRI-PDFF.
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Outcome measures
| Measure |
Placebo
n=26 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=25 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=23 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=23 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)
|
-0.69 percentage
Standard Error 5.818
|
-2.27 percentage
Standard Error 6.036
|
-13.94 percentage
Standard Error 6.232
|
-18.00 percentage
Standard Error 6.012
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
|
0.49 percentage
Interval -8.68 to 15.46
|
1.44 percentage
Interval -17.85 to 9.31
|
-8.32 percentage
Interval -28.91 to 7.29
|
-15.29 percentage
Interval -35.87 to 7.06
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Outcome measures
| Measure |
Placebo
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=13 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])
|
-6.11 percentage
Standard Deviation 9.745
|
1.15 percentage
Standard Deviation 9.266
|
-16.71 percentage
Standard Deviation 8.997
|
-27.24 percentage
Standard Deviation 9.572
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment
|
0.023 percentage
Standard Error 1.1117
|
-0.218 percentage
Standard Error 1.1801
|
-2.548 percentage
Standard Error 1.1988
|
-2.391 percentage
Standard Error 1.1399
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment. For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.
Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF
Outcome measures
| Measure |
Placebo
n=27 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=26 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=23 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=24 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment
Relative reduction ≥30%
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment
Relative reduction <30%
|
25 Participants
|
22 Participants
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment
|
1.0 U/L
Standard Error 2.88
|
0.0 U/L
Standard Error 2.95
|
0.3 U/L
Standard Error 3.10
|
-6.3 U/L
Standard Error 3.04
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment
|
-2.8 U/L
Standard Error 1.95
|
-1.7 U/L
Standard Error 1.99
|
-2.2 U/L
Standard Error 2.08
|
-7.0 U/L
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment
|
0.36 mmol/L
Standard Error 0.199
|
0.19 mmol/L
Standard Error 0.205
|
-0.17 mmol/L
Standard Error 0.211
|
-0.16 mmol/L
Standard Error 0.209
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment
|
0.05 percent
Standard Error 0.092
|
-0.08 percent
Standard Error 0.095
|
-0.18 percent
Standard Error 0.101
|
-0.24 percent
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline to Week12/End of Treatment
|
0.107 mmol/L
Standard Error 0.1650
|
-0.144 mmol/L
Standard Error 0.1714
|
0.058 mmol/L
Standard Error 0.1761
|
0.081 mmol/L
Standard Error 0.1764
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment
|
-0.007 mmol/L
Standard Error 0.0357
|
-0.025 mmol/L
Standard Error 0.0371
|
-0.085 mmol/L
Standard Error 0.0381
|
0.002 mmol/L
Standard Error 0.0375
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment
|
0.011 mmol/L
Standard Error 0.1401
|
-0.094 mmol/L
Standard Error 0.1391
|
0.155 mmol/L
Standard Error 0.1427
|
0.092 mmol/L
Standard Error 0.1456
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Triglycerides From Baseline to Week12/End of Treatment
|
0.156 mmol/L
Standard Error 0.2177
|
-0.006 mmol/L
Standard Error 0.2278
|
0.017 mmol/L
Standard Error 0.2330
|
-0.045 mmol/L
Standard Error 0.2291
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 \< 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 \> 3.25: cirrhosis. Fib-4 score was calculated as (Age \[years\] × AST \[U/L\]) / (platelet \[10\^9/L\] × √\[ALT \[U/L\]\]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment
|
-0.11 Fib-4 score
Standard Error 0.060
|
-0.07 Fib-4 score
Standard Error 0.062
|
-0.09 Fib-4 score
Standard Error 0.064
|
-0.15 Fib-4 score
Standard Error 0.063
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.
Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.
Outcome measures
| Measure |
Placebo
n=31 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in Body Weight From Baseline to Week 12/End of Treatment
|
0.96 kg
Standard Error 0.476
|
0.92 kg
Standard Error 0.486
|
0.20 kg
Standard Error 0.508
|
0.08 kg
Standard Error 0.505
|
POST_HOC outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment. For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.
Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF
Outcome measures
| Measure |
Placebo
n=11 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=10 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment (T2DM Subgroup)
Relative reduction ≥30%
|
1 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment (T2DM Subgroup)
Relative reduction <30%
|
10 Participants
|
10 Participants
|
9 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=13 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in ALT From Baseline to Week 12/End of Treatment (T2DM Subgroup)
|
2.1 U/L
Standard Error 4.36
|
-2.2 U/L
Standard Error 4.20
|
-3.8 U/L
Standard Error 4.19
|
-12.8 U/L
Standard Error 4.59
|
POST_HOC outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=13 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in AST From Baseline to Week 12/End of Treatment (T2DM Subgroup)
|
-0.8 U/L
Standard Deviation 2.92
|
-3.7 U/L
Standard Deviation 2.87
|
-0.9 U/L
Standard Deviation 2.82
|
-10.7 U/L
Standard Deviation 3.09
|
POST_HOC outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=13 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in FPG From Baseline to Week12/End of Treatment (T2DM Subgroup)
|
0.54 mmol/L
Standard Error 0.399
|
0.51 mmol/L
Standard Error 0.404
|
-0.29 mmol/L
Standard Error 0.384
|
-0.65 mmol/L
Standard Error 0.427
|
POST_HOC outcome
Timeframe: Baseline to Week 12Population: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Outcome measures
| Measure |
Placebo
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks
|
PXL770 250 mg QD
n=13 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=14 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=12 Participants
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week12/End of Treatment (T2DM Subgroup)
|
0.20 percent
Standard Error 0.175
|
-0.04 percent
Standard Error 0.176
|
-0.23 percent
Standard Error 0.175
|
-0.44 percent
Standard Error 0.188
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PXL770 250 mg QD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PXL770 250 mg BID
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
PXL770 500 mg QD
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg QD
n=30 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.4%
1/29 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.4%
1/29 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Infections and infestations
Sepsis
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.3%
1/30 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.3%
1/30 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg QD
n=30 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 250 mg BID
n=30 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
PXL770 500 mg QD
n=29 participants at risk
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
16.7%
5/30 • Number of events 5 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
23.3%
7/30 • Number of events 8 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
20.7%
6/29 • Number of events 7 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.3%
1/30 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
13.8%
4/29 • Number of events 4 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 6 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.9%
2/29 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.9%
2/29 • Number of events 3 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.3%
1/30 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.4%
1/29 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Infections and infestations
Gastroenteritis viral
|
6.5%
2/31 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.9%
2/29 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
10.0%
3/30 • Number of events 3 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
13.3%
4/30 • Number of events 5 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.9%
2/29 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
10.0%
3/30 • Number of events 3 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
3.4%
1/29 • Number of events 1 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Number of events 3 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 3 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.7%
2/30 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
Surgical and medical procedures
Tooth extraction
|
6.5%
2/31 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/29 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
|
General disorders
Pyrexia
|
0.00%
0/31 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
0.00%
0/30 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
6.9%
2/29 • Number of events 2 • All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place