Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)

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NCT07290257 · readout in 1,495 d

Sponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.

Phase

Phase 4

Status

Recruiting

Study type

Interventional

Design

Na · None · Other

Enrollment

230estimated

Sites

Countries

Belgium, France, Germany +5

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-09-25

actual

When the study began enrolling

Primary completion

2030-09-22

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-12-22

estimated

The whole study's end, after follow-up

First posted

2025-12-18

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-23

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Alagille Syndrome
Progressive Familial Intrahepatic Cholestasis

Intervention

Drug: Livmarli Oral Product — also filed as Maralixibat

Primary outcomes

what the primary-completion date above is the date OF

Adverse Events (AEs)

measured Up to 7 days after the last dose of Livmarli.

Liver function tests (LFTs) - measuring enzyme activity or concentration