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A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513762-18-00
Acronym
747-213
Enrollment
65
Registered
2024-06-14
Start date
2019-09-20
Completion date
2025-10-14
Last updated
2025-07-18

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

Conditions

Primary Biliary Cholangitis (PBC)

Brief summary

Change in ALP from baseline to Week 12 in the DB Period

Detailed description

The response rates of ≥10%, ≥20%, ≥30%, and ≥40% reduction from baseline and normalization rates of ALP at Week 12, Normalization rates at Week 12 of GGT, ALT, AST, ALP, total and conjugated bilirubin, and a lipid panel, Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and a lipid panel, Change from baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4) and bile acids

Interventions

DRUGOCALIVA
DRUGPlacebo for Bezafibrate
DRUGBezalip Mono
DRUGPlacebo for Obeticholic Acid
DRUGBezalip

Sponsors

Intercept Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in ALP from baseline to Week 12 in the DB Period—

Secondary

MeasureTime frame
The response rates of ≥10%, ≥20%, ≥30%, and ≥40% reduction from baseline and normalization rates of ALP at Week 12, Normalization rates at Week 12 of GGT, ALT, AST, ALP, total and conjugated bilirubin, and a lipid panel, Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and a lipid panel, Change from baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4) and bile acids—

Countries

Belgium, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Lithuania, Netherlands, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026