Trial Outcomes & Findings for Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC) (NCT NCT04480840)
NCT ID: NCT04480840
Last Updated: 2026-01-23
Results Overview
Nature and proportion of TEAEs between PLN-74809 and placebo groups. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Up to 40 weeks
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
24
|
20
|
20
|
27
|
|
Overall Study
COMPLETED
|
28
|
22
|
19
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
illicit drug use
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=24 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=20 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 3
n=20 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=27 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 11.65 • n=270 Participants
|
46.9 years
STANDARD_DEVIATION 15.06 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 15.32 • n=9 Participants
|
45.1 years
STANDARD_DEVIATION 12.65 • n=220 Participants
|
47.1 years
STANDARD_DEVIATION 14.47 • n=3 Participants
|
44.9 years
STANDARD_DEVIATION 13.91 • n=18 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=220 Participants
|
14 Participants
n=3 Participants
|
37 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=270 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
14 Participants
n=220 Participants
|
13 Participants
n=3 Participants
|
84 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=270 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=9 Participants
|
18 Participants
n=220 Participants
|
25 Participants
n=3 Participants
|
110 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=270 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
18 Participants
n=220 Participants
|
26 Participants
n=3 Participants
|
105 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=270 Participants
|
10 participants
n=4 Participants
|
5 participants
n=9 Participants
|
9 participants
n=220 Participants
|
9 participants
n=3 Participants
|
44 participants
n=18 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=270 Participants
|
2 participants
n=4 Participants
|
3 participants
n=9 Participants
|
1 participants
n=220 Participants
|
2 participants
n=3 Participants
|
7 participants
n=18 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=270 Participants
|
0 participants
n=4 Participants
|
0 participants
n=9 Participants
|
0 participants
n=220 Participants
|
2 participants
n=3 Participants
|
3 participants
n=18 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=270 Participants
|
0 participants
n=4 Participants
|
0 participants
n=9 Participants
|
1 participants
n=220 Participants
|
1 participants
n=3 Participants
|
2 participants
n=18 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=270 Participants
|
12 participants
n=4 Participants
|
10 participants
n=9 Participants
|
6 participants
n=220 Participants
|
4 participants
n=3 Participants
|
43 participants
n=18 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=270 Participants
|
0 participants
n=4 Participants
|
1 participants
n=9 Participants
|
3 participants
n=220 Participants
|
3 participants
n=3 Participants
|
10 participants
n=18 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=270 Participants
|
2 participants
n=4 Participants
|
0 participants
n=9 Participants
|
0 participants
n=220 Participants
|
4 participants
n=3 Participants
|
8 participants
n=18 Participants
|
|
Region of Enrollment
France
|
1 participants
n=270 Participants
|
0 participants
n=4 Participants
|
0 participants
n=9 Participants
|
0 participants
n=220 Participants
|
0 participants
n=3 Participants
|
1 participants
n=18 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=270 Participants
|
0 participants
n=4 Participants
|
1 participants
n=9 Participants
|
0 participants
n=220 Participants
|
2 participants
n=3 Participants
|
3 participants
n=18 Participants
|
|
BMI at Screening
|
26.44 kg/m^2
STANDARD_DEVIATION 3.562 • n=270 Participants
|
28.21 kg/m^2
STANDARD_DEVIATION 5.167 • n=4 Participants
|
26.45 kg/m^2
STANDARD_DEVIATION 4.506 • n=9 Participants
|
26.82 kg/m^2
STANDARD_DEVIATION 5.950 • n=220 Participants
|
24.60 kg/m^2
STANDARD_DEVIATION 3.069 • n=3 Participants
|
26.52 kg/m^2
STANDARD_DEVIATION 4.566 • n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 40 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug
Nature and proportion of TEAEs between PLN-74809 and placebo groups. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=20 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=20 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=30 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=24 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=27 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
15 Participants
|
16 Participants
|
21 Participants
|
10 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Up to 40 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug
Nature and proportion of Serious TEAEs between PLN-74809 and placebo groups. An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=20 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=20 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=30 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=24 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=27 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Treatment Emergent Adverse Events
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=19 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=18 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=22 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=21 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=24 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assessment of PLN-74809 Total Plasma Concentrations at Week 12
|
2035.95 ng/mL
Standard Deviation 1020.567
|
843.06 ng/mL
Standard Deviation 474.312
|
0.00 ng/mL
Standard Deviation 0.00
|
638.71 ng/mL
Standard Deviation 378.193
|
3667.50 ng/mL
Standard Deviation 1598.067
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
Outcome measures
| Measure |
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=9 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=22 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assessment of PLN-74809 Total Plasma Concentrations at Week 24
|
—
|
—
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
3583.64 ng/mL
Standard Deviation 1642.404
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 12Population: Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set.
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens) which combines the 3 different tests that use 3 different units to produce a number that does not have a unit. ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \>7.7-9.8 is moderate, \>9.8 is severe.
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=19 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=19 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=28 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=21 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=26 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 12
|
0.09 Unitless
Standard Deviation 0.55
|
0.19 Unitless
Standard Deviation 0.51
|
0.42 Unitless
Standard Deviation 0.75
|
0.16 Unitless
Standard Deviation 0.58
|
0.19 Unitless
Standard Deviation 0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 24Population: Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set. Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens) which combines the 3 different tests that use 3 different units to produce a number that does not have a unit. ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \>7.7-9.8 is moderate, \>9.8 is severe.
Outcome measures
| Measure |
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=9 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=24 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 24
|
—
|
—
|
0.14 Unitless
Standard Deviation 0.58
|
—
|
0.19 Unitless
Standard Deviation 0.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 12Population: Participants with baseline and at least one post baseline assessment
Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 12
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=19 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=19 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=28 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=22 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=25 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12
|
-7.5 U/L
Standard Deviation 34.63
|
4.8 U/L
Standard Deviation 33.56
|
40.2 U/L
Standard Deviation 130.94
|
7.5 U/L
Standard Deviation 83.20
|
1.7 U/L
Standard Deviation 44.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 24Population: Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment
Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 24
Outcome measures
| Measure |
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=9 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=24 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 24
|
—
|
—
|
34.4 U/L
Standard Deviation 56.57
|
—
|
-26.1 U/L
Standard Deviation 66.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 12Population: Participants with baseline and at least one post baseline assessment
Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 12
Outcome measures
| Measure |
PLN-74809 Dose Level 3
n=18 Participants
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=17 Participants
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=28 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=21 Participants
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=25 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 12
|
5.20 Percent Change
Standard Deviation 30.899
|
7.12 Percent Change
Standard Deviation 20.328
|
22.35 Percent Change
Standard Deviation 53.183
|
-3.78 Percent Change
Standard Deviation 20.471
|
2.70 Percent Change
Standard Deviation 36.130
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 24Population: Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment
Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 24
Outcome measures
| Measure |
PLN-74809 Dose Level 3
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
Placebo
n=9 Participants
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=23 Participants
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 24
|
—
|
—
|
-1.38 Percent Change
Standard Deviation 36.859
|
—
|
-12.74 Percent Change
Standard Deviation 26.539
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
PLN-74809 Dose Level 1
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
PLN-74809 Dose Level 2
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
PLN-74809 Dose Level 3
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
PLN-74809 Dose Level 4
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=30 participants at risk
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=24 participants at risk
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=20 participants at risk
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 3
n=20 participants at risk
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=27 participants at risk
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholangitis
|
3.3%
1/30 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Enterobacter bacteramia
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Placebo: Placebo (Part 1, 2, and 3)
|
PLN-74809 Dose Level 1
n=24 participants at risk
Part 1, Cohort 1
Dose: 40 mg, up to 12 weeks
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 2
n=20 participants at risk
Part 2, Cohort 2
Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 3
n=20 participants at risk
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
|
PLN-74809 Dose Level 4
n=27 participants at risk
Part 3, Cohort 4
Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809: PLN-74809
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
7.4%
2/27 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
14.8%
4/27 • Number of events 4 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
10.0%
3/30 • Number of events 4 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
13.3%
4/30 • Number of events 4 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
18.5%
5/27 • Number of events 5 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
1/30 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
18.5%
5/27 • Number of events 6 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
16.7%
5/30 • Number of events 6 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
12.5%
3/24 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
20.0%
4/20 • Number of events 5 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 4 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
6/30 • Number of events 9 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
8.3%
2/24 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
20.0%
4/20 • Number of events 4 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 5 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
15.0%
3/20 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
11.1%
3/27 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
13.3%
4/30 • Number of events 6 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.7%
1/27 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Ocular icterus
|
10.0%
3/30 • Number of events 3 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/24 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/20 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/27 • Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
Additional Information
Pliant Therapeutics Medical Monitor
Pliant Therapeutics
Phone: 650-481-6770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER