Trial · NCT04480840

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

NCT04480840, Phase 2, Completed, Pliant Therapeutics, Inc.; results first posted 2026-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC). Trials, record NCT04480840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04480840

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
NCT number: NCT04480840
Status: Completed
Phases: Phase 2
Enrollment: 121 participants, actual
Lead sponsor: Pliant Therapeutics, Inc.
Conditions: Primary Sclerosing Cholangitis
Interventions: PLN-74809, Placebo
First posted: 2020-07-21
Last updated: 2026-01-23
Results first posted: 2026-01-23

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Emergent Adverse Events	Up to 40 weeks	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
Primary	Number of Participants With Serious Treatment Emergent Adverse Events	Up to 40 weeks	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.
Secondary	Assessment of PLN-74809 Total Plasma Concentrations at Week 12	Up to 12 weeks	Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose
Secondary	Assessment of PLN-74809 Total Plasma Concentrations at Week 24	Up to 24 weeks	Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
Other	Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 12	Baseline to week 12	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.
Other	Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 24	Baseline to week 24	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.
Other	Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12	Baseline to week 12	Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 12
Other	Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 24	Baseline to week 24	Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 24
Other	Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 12	Baseline to week 12	Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 12
Other	Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 24	Baseline to week 24	Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 24

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Emergent Adverse Events	Up to 40 weeks	Safety Population included all participants who took at least 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Serious Treatment Emergent Adverse Events	Up to 40 weeks	Safety Population included all participants who took at least 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Assessment of PLN-74809 Total Plasma Concentrations at Week 12	Up to 12 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.	ng/mL	MEAN
SECONDARY	Assessment of PLN-74809 Total Plasma Concentrations at Week 24	Up to 24 weeks	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.	ng/mL	MEAN
OTHER_PRE_SPECIFIED	Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 12	Baseline to week 12	Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set.	Unitless	MEAN
OTHER_PRE_SPECIFIED	Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 24	Baseline to week 24	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	Unitless	MEAN
OTHER_PRE_SPECIFIED	Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12	Baseline to week 12	Participants with baseline and at least one post baseline assessment	U/L	MEAN
OTHER_PRE_SPECIFIED	Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 24	Baseline to week 24	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	U/L	MEAN
OTHER_PRE_SPECIFIED	Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 12	Baseline to week 12	Participants with baseline and at least one post baseline assessment	Percent Change	MEAN
OTHER_PRE_SPECIFIED	Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 24	Baseline to week 24	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	Percent Change	MEAN

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Treatment Emergent Adverse Events	Placebo	21	Participants
Number of Participants With Treatment Emergent Adverse Events	PLN-74809 Dose Level 1	10	Participants
Number of Participants With Treatment Emergent Adverse Events	PLN-74809 Dose Level 2	16	Participants
Number of Participants With Treatment Emergent Adverse Events	PLN-74809 Dose Level 3	15	Participants
Number of Participants With Treatment Emergent Adverse Events	PLN-74809 Dose Level 4	23	Participants
Number of Participants With Serious Treatment Emergent Adverse Events	Placebo	1	Participants
Number of Participants With Serious Treatment Emergent Adverse Events	PLN-74809 Dose Level 1	1	Participants
Number of Participants With Serious Treatment Emergent Adverse Events	PLN-74809 Dose Level 2	1	Participants
Number of Participants With Serious Treatment Emergent Adverse Events	PLN-74809 Dose Level 3	0	Participants
Number of Participants With Serious Treatment Emergent Adverse Events	PLN-74809 Dose Level 4	1	Participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	30
Overall Study	STARTED	PLN-74809 Dose Level 1	24
Overall Study	STARTED	PLN-74809 Dose Level 2	20
Overall Study	STARTED	PLN-74809 Dose Level 3	20
Overall Study	STARTED	PLN-74809 Dose Level 4	27
Overall Study	COMPLETED	Placebo	28
Overall Study	COMPLETED	PLN-74809 Dose Level 1	22
Overall Study	COMPLETED	PLN-74809 Dose Level 2	19
Overall Study	COMPLETED	PLN-74809 Dose Level 3	19
Overall Study	COMPLETED	PLN-74809 Dose Level 4	23

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events115

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Placebo	0	30	0
other	Nausea	Gastrointestinal disorders	PLN-74809 Dose Level 1	1	24	1
other	Nausea	Gastrointestinal disorders	PLN-74809 Dose Level 2	2	20	2
other	Nausea	Gastrointestinal disorders	PLN-74809 Dose Level 3	3	20	3
other	Nausea	Gastrointestinal disorders	PLN-74809 Dose Level 4	1	27	1
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	30	1
other	Abdominal pain upper	Gastrointestinal disorders	PLN-74809 Dose Level 1	2	24	2
other	Abdominal pain upper	Gastrointestinal disorders	PLN-74809 Dose Level 2	2	20	2
other	Abdominal pain upper	Gastrointestinal disorders	PLN-74809 Dose Level 3	0	20	0
other	Abdominal pain upper	Gastrointestinal disorders	PLN-74809 Dose Level 4	2	27	2

1 to 10 of 115Source ClinicalTrials.gov

See all 115 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	30
Total, all-cause mortality	PLN-74809 Dose Level 1	0	24
Total, all-cause mortality	PLN-74809 Dose Level 2	0	20
Total, all-cause mortality	PLN-74809 Dose Level 3	0	20
Total, all-cause mortality	PLN-74809 Dose Level 4	0	27
Total, other adverse events	Placebo	21	30
Total, other adverse events	PLN-74809 Dose Level 1	10	24
Total, other adverse events	PLN-74809 Dose Level 2	16	20
Total, other adverse events	PLN-74809 Dose Level 3	15	20
Total, other adverse events	PLN-74809 Dose Level 4	23	27

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41016442	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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