Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH) (NCT NCT03812029)
NCT ID: NCT03812029
Last Updated: 2023-05-06
Results Overview
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-05-06
Participant Flow
For Part A, data from the 3 vonafexor treatment groups were pooled and summarized. Due to the small number of subjects by treatment group in Part A, and as the Study EYP001 202 Part A Pharmacokinetic (PK) results between groups were found to be nonlinear with similar exposure for the vonafexor 200 mg once daily (QD) and vonafexor 400 mg QD groups, only the pooled vonafexor treatment group were compared with the placebo group.
Participant milestones
| Measure |
Placebo Part A
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
Oral dose once or twice a day according to treatment arm for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part B
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
17
|
32
|
31
|
33
|
|
Overall Study
COMPLETED
|
5
|
7
|
32
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
0
|
6
|
10
|
Reasons for withdrawal
| Measure |
Placebo Part A
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
Oral dose once or twice a day according to treatment arm for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part B
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
2
|
|
Overall Study
Stopping rules
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
9
|
0
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
Baseline characteristics by cohort
| Measure |
Placebo Part A
n=7 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=17 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Age Part A
|
48.7 years
STANDARD_DEVIATION 18.4 • n=7 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
56.1 years
STANDARD_DEVIATION 8.9 • n=17 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
—
|
—
|
—
|
54.0 years
STANDARD_DEVIATION 12.4 • n=24 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Age, Continuous
Age Part B
|
—
|
—
|
57.3 years
STANDARD_DEVIATION 10.3 • n=32 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
58.1 years
STANDARD_DEVIATION 13.7 • n=31 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
54.0 years
STANDARD_DEVIATION 11.9 • n=33 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
56.4 years
STANDARD_DEVIATION 12.0 • n=96 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
14 Participants
n=17 Participants
|
18 Participants
n=32 Participants
|
14 Participants
n=31 Participants
|
21 Participants
n=33 Participants
|
69 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
3 Participants
n=17 Participants
|
14 Participants
n=32 Participants
|
17 Participants
n=31 Participants
|
12 Participants
n=33 Participants
|
51 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=7 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=32 Participants
|
8 Participants
n=31 Participants
|
10 Participants
n=33 Participants
|
31 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=7 Participants
|
12 Participants
n=17 Participants
|
26 Participants
n=32 Participants
|
23 Participants
n=31 Participants
|
23 Participants
n=33 Participants
|
89 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=32 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=33 Participants
|
7 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
29 Participants
n=32 Participants
|
26 Participants
n=31 Participants
|
31 Participants
n=33 Participants
|
109 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=120 Participants
|
|
Height
Height Part A
|
169.0 cm
STANDARD_DEVIATION 7.4 • n=7 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
163.2 cm
STANDARD_DEVIATION 9.9 • n=17 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
—
|
—
|
—
|
164.9 cm
STANDARD_DEVIATION 9.5 • n=24 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Height
Height Part B
|
—
|
—
|
168.1 cm
STANDARD_DEVIATION 9.8 • n=32 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
167.1 cm
STANDARD_DEVIATION 8.5 • n=31 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
166.8 cm
STANDARD_DEVIATION 10.1 • n=33 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
167.3 cm
STANDARD_DEVIATION 9.4 • n=96 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Weight
Weight Part A
|
112.4 kg
STANDARD_DEVIATION 32.6 • n=7 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
103.4 kg
STANDARD_DEVIATION 25.4 • n=17 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
—
|
—
|
—
|
106.0 kg
STANDARD_DEVIATION 27.3 • n=24 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Weight
Weight Part B
|
—
|
—
|
97.5 kg
STANDARD_DEVIATION 18.3 • n=32 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
95.8 kg
STANDARD_DEVIATION 14.0 • n=31 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
98.8 kg
STANDARD_DEVIATION 18.4 • n=33 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
97.4 kg
STANDARD_DEVIATION 16.9 • n=96 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
BMI
BMI Part A
|
39.3 kg/m^2
STANDARD_DEVIATION 10.2 • n=7 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
38.8 kg/m^2
STANDARD_DEVIATION 9.0 • n=17 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
—
|
—
|
—
|
38.9 kg/m^2
STANDARD_DEVIATION 9.1 • n=24 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
BMI
BMI Part B
|
—
|
—
|
34.3 kg/m^2
STANDARD_DEVIATION 4.3 • n=32 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
34.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=31 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
35.4 kg/m^2
STANDARD_DEVIATION 5.1 • n=33 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
34.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=96 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Waist circumference
Waist circumference Part A
|
128.9 cm
STANDARD_DEVIATION 31.5 • n=7 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
116.1 cm
STANDARD_DEVIATION 16.0 • n=17 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
—
|
—
|
—
|
119.8 cm
STANDARD_DEVIATION 21.7 • n=24 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
|
Waist circumference
Waist circumference Part B
|
—
|
—
|
112.6 cm
STANDARD_DEVIATION 13.0 • n=32 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
111.4 cm
STANDARD_DEVIATION 8.6 • n=31 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
114.1 cm
STANDARD_DEVIATION 11.8 • n=33 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
112.7 cm
STANDARD_DEVIATION 11.3 • n=96 Participants • Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/Early Termination (ET) MRI-PDFF measurements of Liver Fat Content (LFC) has been used to analyse this endpoint.
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=5 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=12 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
|
-2.3 Percentage of liver fat change
Interval -4.0 to -0.6
|
-6.3 Percentage of liver fat change
Interval -8.1 to -4.5
|
-5.4 Percentage of liver fat change
Interval -7.2 to -3.6
|
3.9 Percentage of liver fat change
Interval -2.5 to 10.4
|
-4.7 Percentage of liver fat change
Interval -8.5 to 0.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Glomerular Filtration rate_Part B
|
-2.7 mL/min/1.73m2
Interval -6.6 to 1.2
|
6.2 mL/min/1.73m2
Interval 1.9 to 10.2
|
3.2 mL/min/1.73m2
Interval -1.2 to 7.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=5 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=12 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
|
-10.5 Percent change
Interval -19.0 to -2.0
|
-30.4 Percent change
Interval -39.4 to -21.3
|
-25.3 Percent change
Interval -34.3 to -16.2
|
11.7 Percent change
Interval -28.5 to 51.9
|
-25.0 Percent change
Interval -48.4 to -1.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=28 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=5 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=12 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Corrected T1 (CT1)
|
-9.9 msec
Interval -38.5 to 18.7
|
-80.2 msec
Interval -110.6 to -49.8
|
-71.8 msec
Interval -100.4 to -43.2
|
35.0 msec
Interval -27.0 to 97.0
|
-58.2 msec
Interval -98.7 to -17.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The ITT Population, defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint but for this endpoint 1 patient in Vonafexor 200 mg QD part B arm was excluded because he experienced a serious transaminase increase due to previously undiagnosed auto-immune hepatitis.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=7 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=17 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Alanine Aminotransferase (ALT)
|
-11.7 U/L
Interval -18.9 to -4.6
|
-16.3 U/L
Interval -24.1 to -8.4
|
-7.5 U/L
Interval -15.3 to 0.4
|
-4.1 U/L
Interval -27.5 to 19.3
|
17.7 U/L
Interval 1.9 to 33.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=7 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=17 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)
|
-3.9 U/L
Interval -9.9 to 2.2
|
-40.6 U/L
Interval -47.1 to -34.0
|
-34.1 U/L
Interval -40.6 to -27.7
|
3.7 U/L
Interval -7.8 to 15.2
|
-25.2 U/L
Interval -34.2 to -16.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=7 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=17 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Body Weight
|
-0.1 kg
Interval -1.0 to 0.9
|
-1.7 kg
Interval -2.7 to -0.7
|
-2.5 kg
Interval -3.5 to -1.5
|
1.2 kg
Interval -1.0 to 3.4
|
-2.2 kg
Interval -3.7 to -0.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
n=7 Participants
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
n=17 Participants
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Waist Circumference
|
0.1 cm
Interval -1.2 to 1.3
|
-1.2 cm
Interval -2.6 to 0.1
|
-2.2 cm
Interval -3.6 to -0.9
|
-1.8 cm
Interval -5.0 to 1.4
|
-2.9 cm
Interval -5.0 to -0.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.
Outcome measures
| Measure |
Placebo Part B
n=32 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Waist to Hip ratio_Part B
|
0.014 ratio
Interval 0.001 to 0.026
|
-0.017 ratio
Interval -0.031 to -0.003
|
-0.010 ratio
Interval -0.024 to 0.004
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksFor Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.
Outcome measures
| Measure |
Placebo Part B
n=7 Participants
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=17 Participants
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part A
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor Pooled Part A
Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|
|
Analysis of Change From Baseline in Glomerular Filtration rate_Part A
|
-4 mL/min/1.73m^2
Standard Deviation 18.4
|
-11.3 mL/min/1.73m^2
Standard Deviation 12.5
|
—
|
—
|
—
|
Adverse Events
Placebo Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vonafexor 100 mg BID Part A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vonafexor 200 mg QD Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vonafexor 400 mg QD Part A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Part B
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Vonafexor 100 mg QD Part B
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Vonafexor 200 mg QD Part B
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Part A
n=7 participants at risk
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg BID Part A
n=6 participants at risk
Oral dose twice daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part A
n=5 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 400 mg QD Part A
n=6 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part B
n=32 participants at risk
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina instable
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
3.1%
1/32 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Investigations
Transaminases increased
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
Other adverse events
| Measure |
Placebo Part A
n=7 participants at risk
Oral dose twice daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg BID Part A
n=6 participants at risk
Oral dose twice daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part A
n=5 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 400 mg QD Part A
n=6 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Placebo Part B
n=32 participants at risk
Oral dose once daily for 12 weeks (84 days)
Placebo: Oral tablets
|
Vonafexor 100 mg QD Part B
n=31 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
Vonafexor 200 mg QD Part B
n=33 participants at risk
Oral dose once daily for 12 weeks (84 days)
Vonafexor: Oral tablets
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
3.1%
1/32 • Number of events 1 • After dose the first dose of study drug until D96
|
6.5%
2/31 • Number of events 2 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
9.1%
3/33 • Number of events 4 • After dose the first dose of study drug until D96
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
6.2%
2/32 • Number of events 2 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
3.1%
1/32 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
General disorders
Adverse drug reaction
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 3 • After dose the first dose of study drug until D96
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
3.1%
1/32 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Injury, poisoning and procedural complications
Electric shock
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
9.1%
3/33 • Number of events 3 • After dose the first dose of study drug until D96
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Investigations
Transaminases increased
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
6.2%
2/32 • Number of events 2 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
6.5%
2/31 • Number of events 2 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
12.5%
4/32 • Number of events 6 • After dose the first dose of study drug until D96
|
9.7%
3/31 • Number of events 4 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
33.3%
2/6 • Number of events 2 • After dose the first dose of study drug until D96
|
6.2%
2/32 • Number of events 2 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
15.2%
5/33 • Number of events 5 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
6.1%
2/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 2 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
12.1%
4/33 • Number of events 5 • After dose the first dose of study drug until D96
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
9.4%
3/32 • Number of events 3 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
83.3%
5/6 • Number of events 7 • After dose the first dose of study drug until D96
|
80.0%
4/5 • Number of events 5 • After dose the first dose of study drug until D96
|
100.0%
6/6 • Number of events 10 • After dose the first dose of study drug until D96
|
12.5%
4/32 • Number of events 4 • After dose the first dose of study drug until D96
|
61.3%
19/31 • Number of events 29 • After dose the first dose of study drug until D96
|
66.7%
22/33 • Number of events 36 • After dose the first dose of study drug until D96
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
20.0%
1/5 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
6.5%
2/31 • Number of events 2 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Infections and infestations
Gastroenteritis viral
|
14.3%
1/7 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
0.00%
0/31 • After dose the first dose of study drug until D96
|
0.00%
0/33 • After dose the first dose of study drug until D96
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
16.7%
1/6 • Number of events 1 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
6.2%
2/32 • Number of events 2 • After dose the first dose of study drug until D96
|
3.2%
1/31 • Number of events 1 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 1 • After dose the first dose of study drug until D96
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/5 • After dose the first dose of study drug until D96
|
0.00%
0/6 • After dose the first dose of study drug until D96
|
0.00%
0/32 • After dose the first dose of study drug until D96
|
6.5%
2/31 • Number of events 2 • After dose the first dose of study drug until D96
|
3.0%
1/33 • Number of events 2 • After dose the first dose of study drug until D96
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential. The Investigator must consult with the Sponsor before any study data are submitted for publication. The Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.
- Publication restrictions are in place
Restriction type: OTHER