Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid (NCT NCT03124108)

Last Updated: 2019-09-24

Results Overview

Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Baseline, Week 12 (Endpoint)

Results posted on

2019-09-24

Participant Flow

A total of 68 participants were screened, out of which 45 participants were randomized, 15 participants in each of the 3 treatment groups.

Participant milestones

Participant milestones
Measure	Elafibranor 80mg Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo Participants received matching placebo tablets orally once daily for 12 weeks.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	15	14	15
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Elafibranor 80mg Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo Participants received matching placebo tablets orally once daily for 12 weeks.
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=15 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Age, Continuous	56.5 Years STANDARD_DEVIATION 8.7 • n=5 Participants	60.4 Years STANDARD_DEVIATION 6.9 • n=7 Participants	60.5 Years STANDARD_DEVIATION 8.6 • n=5 Participants	59.1 Years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 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
Race (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

PRIMARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Population: The modified Intent-to-Treat (mITT) analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.

Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)	-48.264 Percent change Standard Deviation 14.7676	-40.640 Percent change Standard Deviation 17.3624	3.190 Percent change Standard Deviation 14.8059

SECONDARY outcome

Timeframe: Up to Week 12 (Endpoint)

Percentage of participants with response defined by Composite Risk Scores (ALP Less than \[\<\] 1.67 \* ULN at endpoint, Total BIL within normal limits at endpoint, and \> 15% ALP reduction from baseline to Endpoint) was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction From Baseline to Endpoint)	66.7 Percentage of participants	78.6 Percentage of participants	6.7 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 12 (Endpoint)

Percentage of participants with response defined by composite risk scores (ALP \< 2 \* ULN at endpoint, Total BIL within normal limits at endpoint, and \> 40% ALP reduction from baseline to endpoint) was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction From Baseline to Endpoint)	73.3 Percentage of participants	42.9 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (\<=) 3 \* ULN and aspartate aminotransferase (AST) \<= 2 \* ULN and bilirubin within normal limits.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Based on PARIS I Risk Score at Endpoint	80.0 Percentage of participants	78.6 Percentage of participants	53.3 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

Percentage of participants with response based on Paris II risk score was defined as ALP \<= 1.5 \* ULN and AST \<= 1.5 \* ULN and bilirubin within normal limits.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Based on PARIS II Risk Score at Endpoint	53.3 Percentage of participants	50.0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

Percentage of participants with response based on Toronto I risk score was defined as ALP \<= 1.67 \*ULN.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Based on Toronto I Risk Score at Endpoint	66.7 Percentage of participants	78.6 Percentage of participants	6.7 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

Percentage of participants with response based on Toronto II risk scores was defined as ALP \<= 1.75 \* ULN.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Based on Toronto II Risk Score at Endpoint	66.7 Percentage of participants	78.6 Percentage of participants	6.7 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

UK-PBC risk score at endpoint estimated that the median percentage risk that a participant treated with ursodeoxycholic acid (UDCA) will develop liver failure requiring liver transplant in 5, 10 and 15 years. UK-PBC score was calculated at each of the 3 survivor functions 1-baseline survival function\^exp(0.0287854\*\[alpEPxuln-1.722136304\] - 0.0422873\*\[{(altastEPxuln/10)\^-1} - 8.675729006\] + 1.4199 \* \[ln{bilEPxuln /10}+2.709607778\] -1.960303\*\[albxlln -1.17673001\]-0.4161954\*\[ pltxlln -1.873564875\]). Where: Baseline survivor function=0. 982 (at 5 years); 0. 941 (at 10 years); 0.893 (at 15 years). alpEPxuln = ALP at endpoint/upper level normal ALP; altastEPxuln=(ALT, AST) at endpoint/upper level normal of the value; bilEPxuln=bilirubin at endpoint/upper level normal bilirubin; albxlln=albumin at baseline/albumin lower level normal; pltxlln=platelet count at baseline/ platelet count lower level normal.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint 10 year risk at Week 12	2.60 Percentage risk Interval 0.3 to 18.8	3.05 Percentage risk Interval 0.8 to 18.1	4.40 Percentage risk Interval 0.5 to 12.0
Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint 5 year risk at Week 12	0.80 Percentage risk Interval 0.1 to 6.0	0.95 Percentage risk Interval 0.2 to 5.8	1.30 Percentage risk Interval 0.1 to 3.7
Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint 15 year risk at Week 12	4.70 Percentage risk Interval 0.6 to 32.1	5.55 Percentage risk Interval 1.5 to 31.0	8.00 Percentage risk Interval 0.9 to 21.1

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

Percentage of participants with response (defined by at least 10%, 20%, and 40% decrease in ALP from baseline to Endpoint) reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase 40 Percent Reduction	86.7 Percentage of participants	57.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase 10 Percent Reduction	93.3 Percentage of participants	92.9 Percentage of participants	13.3 Percentage of participants
Percentage of Participants With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase 20 Percent Reduction	93.3 Percentage of participants	92.9 Percentage of participants	6.7 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

The response was defined by normalized ALP levels (ALP ULN 105 units per liter \[U/L\] for females, 129 U/L for males) at endpoint.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Endpoint	13.3 Percentage of participants	21.4 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

The response was defined by normalized BIL levels (BIL ULN \<1.20 milligram per deciliter \[mg/dL\]) at endpoint.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by Normalized Bilirubin (BIL) at Endpoint	86.7 Percentage of participants	92.9 Percentage of participants	93.3 Percentage of participants

SECONDARY outcome

Timeframe: At Week 12 (Endpoint)

The response was defined by normalized ALB levels (3.5-5.2 gram per deciliter \[g/dL\] for ages 18-60 years; 3.2-4.6 g/dL for ages 61-91 years) at endpoint.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Percentage of Participants With Response Defined by Normalized Albumin (ALB) Levels at Endpoint	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in ALT levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Endpoint	-0.5 U/L Standard Deviation 57.38	7.3 U/L Standard Deviation 29.13	-1.2 U/L Standard Deviation 8.57

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in AST levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Endpoint	6.0 U/L Standard Deviation 55.29	11.1 U/L Standard Deviation 27.96	-4.3 U/L Standard Deviation 7.97

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in GGT levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at Endpoint	-91.5 U/L Standard Deviation 95.30	-61.9 U/L Standard Deviation 70.82	0.6 U/L Standard Deviation 54.40

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in 5' nucleotidase levels at endpoint was reported. 5' nucleotidase is an enzyme used as a biomarker of hepatobiliary cholestasis and is less sensitive but more specific than GGT and ALP.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in 5 Prime (') Nucleotidase Levels at Endpoint	-7.81 U/L Standard Deviation 8.279	-4.59 U/L Standard Deviation 13.067	-0.47 U/L Standard Deviation 3.491

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in total BIL levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Total Bilirubin (BIL) Levels at Endpoint	-0.23 micromole per liter (mcmol/L) Standard Deviation 3.425	-0.51 micromole per liter (mcmol/L) Standard Deviation 2.821	-0.01 micromole per liter (mcmol/L) Standard Deviation 3.548

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in conjugated bilirubin levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Conjugated Bilirubin Levels at Endpoint	0.34 mcmol/L Standard Deviation 2.229	-0.06 mcmol/L Standard Deviation 0.596	0.45 mcmol/L Standard Deviation 1.526

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in albumin levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Albumin Levels at Endpoint	2.2 gram per liter (g/L) Standard Deviation 2.54	2.3 gram per liter (g/L) Standard Deviation 2.73	0.0 gram per liter (g/L) Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in cholesterol levels at endpoints was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Cholesterol Levels at Endpoint	-0.455 millimole per liter (mmol/L) Standard Deviation 0.7479	-0.387 millimole per liter (mmol/L) Standard Deviation 0.6308	0.043 millimole per liter (mmol/L) Standard Deviation 0.3706

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in LDL-cholesterol at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol Levels at Endpoint	-0.366 mmol/L Standard Deviation 0.5919	-0.334 mmol/L Standard Deviation 0.4848	0.061 mmol/L Standard Deviation 0.3272

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in HDL-cholesterol levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Levels at Endpoint	-0.017 mmol/L Standard Deviation 0.3898	0.059 mmol/L Standard Deviation 0.3391	-0.007 mmol/L Standard Deviation 0.2988

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in triglycerides levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Triglycerides Levels at Endpoint	-0.155 mmol/L Standard Deviation 0.3460	-0.253 mmol/L Standard Deviation 0.2085	-0.019 mmol/L Standard Deviation 0.3776

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in total free bile acid levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Total Free Bile Acid Levels at Endpoint	-248.88 10^-9 mole per liter (mol/L) Standard Deviation 2496.672	-673.71 10^-9 mole per liter (mol/L) Standard Deviation 2962.097	-135.20 10^-9 mole per liter (mol/L) Standard Deviation 6777.727

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in total conjugated bile acid levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Total Conjugated Bile Acid Levels at Endpoint	5008.99 10^-9 mol/L Standard Deviation 17844.304	-3280.16 10^-9 mol/L Standard Deviation 10941.769	1873.22 10^-9 mol/L Standard Deviation 21795.349

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in total bile acid levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Total Bile Acid Levels at Endpoint	4760.11 10^-9 mol/L Standard Deviation 18919.661	-3953.86 10^-9 mol/L Standard Deviation 12008.620	1738.02 10^-9 mol/L Standard Deviation 26521.746

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in 7 alpha-hydroxy-4-cholesten-3-one levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in 7 Alpha-hydroxy-4-cholesten-3-one Levels at Endpoint	-16.29 10^-9 mol/L Standard Deviation 27.584	-10.04 10^-9 mol/L Standard Deviation 28.606	5.22 10^-9 mol/L Standard Deviation 10.848

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in fibroblast growth factor-19 levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Fibroblast Growth Factor-19 Levels at Endpoint	-21.67 nanogram per liter (ng/L) Standard Deviation 52.588	-16.96 nanogram per liter (ng/L) Standard Deviation 38.933	-47.08 nanogram per liter (ng/L) Standard Deviation 69.560

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in IgM levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Immunoglobulin M (IgM) Levels at Endpoint	-0.339 g/L Standard Deviation 0.5846	-0.472 g/L Standard Deviation 0.5507	-0.076 g/L Standard Deviation 0.7227

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in tumor necrosis factor levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Tumor Necrosis Factor Levels at Endpoint	0.066 ng/L Standard Deviation 0.7829	0.154 ng/L Standard Deviation 1.1374	0.053 ng/L Standard Deviation 0.8329

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in transforming growth factor beta levels at endpoint was reported,

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Transforming Growth Factor Beta Levels at Endpoint	734.7 ng/L Standard Deviation 2103.75	297.2 ng/L Standard Deviation 2762.61	-1163.0 ng/L Standard Deviation 4295.49

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in interleukin 6 levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Interleukin 6 Levels at Endpoint	-0.021 ng/L Standard Deviation 0.8337	-0.261 ng/L Standard Deviation 0.5213	-0.165 ng/L Standard Deviation 0.5624

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in plasminogen activator inhibitor-1 AG levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Plasminogen Activator Inhibitor-1 Antigen (AG) Levels at Endpoint	-0.483 microgram per liter (mcg/L) Standard Deviation 2.9839	-1.739 microgram per liter (mcg/L) Standard Deviation 4.6587	-1.456 microgram per liter (mcg/L) Standard Deviation 4.6448

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in cytokeratin-18 (M30 and M65) levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Cytokeratin-18 Levels at Endpoint Cytokeratin-18 M30	26.12 picomole per liter (pmol/L) Standard Deviation 472.247	163.33 picomole per liter (pmol/L) Standard Deviation 499.500	17.93 picomole per liter (pmol/L) Standard Deviation 307.531
Change From Baseline in Cytokeratin-18 Levels at Endpoint Cytokeratin-18 M65	114.31 picomole per liter (pmol/L) Standard Deviation 627.068	238.97 picomole per liter (pmol/L) Standard Deviation 611.520	-53.16 picomole per liter (pmol/L) Standard Deviation 131.934

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in autotaxin levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Autotaxin Levels at Endpoint	4.6 mcg/L Standard Deviation 156.92	49.9 mcg/L Standard Deviation 77.25	35.1 mcg/L Standard Deviation 161.58

SECONDARY outcome

Timeframe: Week 12 (Endpoint)

C-reactive protein level at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
C-reactive Protein Level at Endpoint	2.74 milligram per liter (mg/L) Interval 1.81 to 4.14	2.84 milligram per liter (mg/L) Interval 1.68 to 4.78	4.01 milligram per liter (mg/L) Interval 2.52 to 6.37

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in haptoglobin levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Haptoglobin Levels at Endpoint	-0.265 g/L Standard Deviation 0.4271	-0.254 g/L Standard Deviation 0.1088	0.025 g/L Standard Deviation 0.2244

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Change from baseline in fibrinogen levels at endpoint was reported.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Fibrinogen Levels at Endpoint	-0.865 g/L Standard Deviation 0.9472	-0.452 g/L Standard Deviation 0.5780	-0.072 g/L Standard Deviation 1.0936

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Population: The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

5 dimensional (5D)-Itch Scale is a reliable, multidimensional measure of itching that has been validated in participants with chronic pruritus to detect changes over time. It consists of 5 domains: duration, degree, direction, disability, and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items (sleep, leisure/social, housework/errands, work/school). All items of the first four domains were measured on a 5-point Likert scale. The distribution domain included 16 potential locations of itch, including 15 body part items (head/scalp, soles, face, palms, chest, abdomen, back, buttocks, thighs, lower legs, tops of feet/toes, tops of hands/fingers, upper arms, groin, forearms) and one point of contact with clothing or bandages. Scores of each of five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=12 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in 5D-Itch Scale Total Score	-2.1 Units on a scale Standard Deviation 5.15	-0.1 Units on a scale Standard Deviation 2.19	0.8 Units on a scale Standard Deviation 4.93

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

Population: The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

The VAS is a reliable and validated method of pruritus assessment. The VAS is adequate in assessing the severity of the symptom; it does not take into account other aspects of pruritus, such as the relative impact of pruritus on quality of life. The VAS, for pruritus assessment, requires the participant to use abstract thought processes to convert their itch severity to a mark on a continuum. A participant draws a line anywhere on the scale ranging from 0 to 10 (where 0 represents 'no itching' and 10 represents 'worst possible itching') that best represents the severity of participant's itching and the scoring involves manual measuring of the mark with a ruler on range of 0 to 100 millimeter (mm). Higher scores indicate worse itching.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=14 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score	-4.4 Units on a scale Standard Deviation 22.80	-4.7 Units on a scale Standard Deviation 11.81	9.3 Units on a scale Standard Deviation 35.93

SECONDARY outcome

Timeframe: Baseline, Week 12 (Endpoint)

PBC-40 QoL Questionnaire is a patient-derived, disease-specific QoL measure developed and validated for use in PBC. It consists of 9 domains with total 40 questions as: 1) digestion and diet (questions 1-3, total score range: 3-15); 2) experiences (questions 4-7, total score range: 4-20); 3) itching (questions 8-10, total score range: 3-15); 4) fatigue (questions 11-18, total score range: 8-40); 5) effort and planning (questions 19-21, total score range: 3-15); 6) memory and concentration (questions 22-27, total score range: 6-30); 7) affects you as a person (questions 28-33, total score range: 6-30); 8) affects your social life (questions 34-37, total score range: 4-20); 9) overall impact on your life (questions 38-40, total score range: 3-15). PBC-40 QoL Questionnaire has 40 questions, each scored on scale of 1-5 (1 = least impact, 5 = greatest impact). For each domain, scoring involved summing individual question response scores. Higher scores indicate poorer quality of life.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=14 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Digestion and Diet	-0.3 Units on a scale Standard Deviation 2.74	-0.6 Units on a scale Standard Deviation 2.24	-0.6 Units on a scale Standard Deviation 3.00
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Fatigue	-1.9 Units on a scale Standard Deviation 4.10	-1.4 Units on a scale Standard Deviation 2.71	-1.5 Units on a scale Standard Deviation 5.04
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Affects your Social Life	1.3 Units on a scale Standard Deviation 3.08	0.0 Units on a scale Standard Deviation 1.47	1.4 Units on a scale Standard Deviation 4.79
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Experiences	0.6 Units on a scale Standard Deviation 2.64	-1.3 Units on a scale Standard Deviation 1.77	-0.7 Units on a scale Standard Deviation 3.69
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Itching	-0.9 Units on a scale Standard Deviation 6.19	-4.1 Units on a scale Standard Deviation 6.56	2.1 Units on a scale Standard Deviation 5.78
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Effort and Planning	-0.9 Units on a scale Standard Deviation 2.03	-0.8 Units on a scale Standard Deviation 1.31	-0.9 Units on a scale Standard Deviation 1.98
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Memory and concentration	0.1 Units on a scale Standard Deviation 3.26	-1.5 Units on a scale Standard Deviation 3.33	-0.5 Units on a scale Standard Deviation 3.25
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Affecting you as a Person	-1.8 Units on a scale Standard Deviation 3.78	-2.5 Units on a scale Standard Deviation 2.85	-1.3 Units on a scale Standard Deviation 3.22
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores Impact on your Life	-0.1 Units on a scale Standard Deviation 3.04	0.6 Units on a scale Standard Deviation 0.63	-1.0 Units on a scale Standard Deviation 3.30

SECONDARY outcome

Timeframe: Up to Week 12

Population: The Safety Set included all randomized participants who were administered at least one dose of study medication.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another medically important condition. TEAEs is defined as (1) it is not present when active phase of study (time of first dose) begins and is not a chronic condition that is part of patient's medical history, or it is present at start of active phase or as part of patient's medical history, but severity/frequency increases during active phase.

Outcome measures

Outcome measures
Measure	Elafibranor 80mg n=15 Participants Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=15 Participants Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 Participants Participants received matching placebo tablets orally once daily for 12 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events TEAEs	12 Participants	13 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events Serious TEAEs	0 Participants	2 Participants	0 Participants

Adverse Events

Elafibranor 80mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 13 deaths

Elafibranor 120mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 13 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Elafibranor 80mg n=15 participants at risk Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=15 participants at risk Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 participants at risk Participants received matching placebo tablets orally once daily for 12 weeks.
Hepatobiliary disorders Autoimmune Hepatitis	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Injury, poisoning and procedural complications Post Procedural Stroke	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Nervous system disorders Ischaemic Stroke	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks

Other adverse events

Other adverse events
Measure	Elafibranor 80mg n=15 participants at risk Participants received elafibranor 80 milligram (mg) tablets orally once daily for 12 weeks.	Elafibranor 120mg n=15 participants at risk Participants received elafibranor 120 mg tablets orally once daily for 12 weeks.	Placebo n=15 participants at risk Participants received matching placebo tablets orally once daily for 12 weeks.
Ear and labyrinth disorders Vertigo	6.7% 1/15 • Number of events 2 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Eye disorders Dry Eye	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Eye disorders Eye ulcer	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Eye disorders Scleral Haemorrhage	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Gastrointestinal disorders Abdominal Distension	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Gastrointestinal disorders Abdominal Pain	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Gastrointestinal disorders Constipation	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • Up to 16 Weeks	13.3% 2/15 • Number of events 2 • Up to 16 Weeks	13.3% 2/15 • Number of events 2 • Up to 16 Weeks
Gastrointestinal disorders Dry Mouth	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Gastrointestinal disorders Nausea	0.00% 0/15 • Up to 16 Weeks	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
General disorders Fatigue	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
General disorders Influenza Like Illness	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
General disorders Local Swelling	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
General disorders Peripheral Swelling	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
General disorders Pyrexia	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Immune system disorders Hypersensitivity	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Infections and infestations Bronchitis	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Gastroenteritis Viral	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Influenza	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Labyrinthitis	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Otitis Externa	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Sinusitis	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Infections and infestations Urinary Tract Infection	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Infections and infestations Viral Upper Respiratory Tract Infection	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	13.3% 2/15 • Number of events 2 • Up to 16 Weeks
Infections and infestations Vulvovaginal Candidiasis	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Injury, poisoning and procedural complications Post-traumatic Neck Syndrome	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Blood Bilirubin Increased	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Blood Cholesterol Increased	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Blood Urine Present	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Investigations Cystoscopy	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Electrocardiogram Abnormal	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Investigations Gamma-glutamyltransferase Increased	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Liver Palpable	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Transaminases Increased	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Urine Albumin/Creatinine Ratio Increased	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 2 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations Urobilinogen Urine Increased	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Investigations White Blood Cells Urine	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Musculoskeletal and connective tissue disorders Back Pain	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Musculoskeletal and connective tissue disorders Bone Pain	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Nervous system disorders Aphasia	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Nervous system disorders Cerebral Amyloid Angiopathy	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Nervous system disorders Dysgeusia	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Nervous system disorders Headache	13.3% 2/15 • Number of events 3 • Up to 16 Weeks	13.3% 2/15 • Number of events 2 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Nervous system disorders Lumbar Radiculopathy	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Psychiatric disorders Insomnia	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Psychiatric disorders Sleep Disorder	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Albuminuria	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 3 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Chromaturia	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Nephrolithiasis	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Nitrituria	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Polyuria	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Proteinuria	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 2 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Renal Colic	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Renal and urinary disorders Renal Pain	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 2 • Up to 16 Weeks
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Alopecia	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	6.7% 1/15 • Number of events 1 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Pruritus	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	20.0% 3/15 • Number of events 3 • Up to 16 Weeks	13.3% 2/15 • Number of events 3 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Skin Disorder	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks
Surgical and medical procedures Stent Removal	6.7% 1/15 • Number of events 1 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks	0.00% 0/15 • Up to 16 Weeks

Additional Information

Clinical Head

Genfit SA

Phone: +33320164000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor retains exclusive ownership of all data, results, reports, findings, discoveries, and any other information collected during this study; these may not be published, given, or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER