Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05190523

Enrollment

Registered

2022-01-13

Start date

2022-04-06

Completion date

2024-03-13

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Keywords

ASC42, primary biliary cholangitis, PBC

Brief summary

This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.

Interventions

DRUGASC42 5 mg

5 mg of ASC42 tablets orally once daily for 12 weeks.

DRUGASC42 10 mg

2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.

DRUGASC42 15 mg

15 mg of ASC42 tablets orally once daily for 12 weeks.

DRUGPlacebo

Placebo tablets orally once daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 18 and ≤75 years old at screening. * Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: 1. Biochemical evidence of cholestasis based on ALP elevation. 2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative. 3. Liver biopsy consistent with PBC. * Screening ALP ≥ 1.67× ULN * Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion criteria

* ALT or AST \> 5× ULN; ALP \>10× ULN * History or presence of other concomitant liver diseases * Child-Pugh grade B or C

Design outcomes

Primary

Measure	Time frame
Percentage changes of alkaline phosphatase (ALP) compared with baseline.	Day85

Secondary

Measure	Time frame
Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.	Day15\29\57\85
Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.	Day15\29\57\85
Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.	Day15\29\57\85

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026