Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
← catalyst calendarNCT06193928 · readout in 763 d
Sponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
70estimated
Sites
8
Country
United States
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 | 2023-09-21 | actual | When the study began enrolling |
| Primary completion | 2028-09-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-09-20 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-25 | 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
Interventions
- Drug: Livmarli — also filed as Maralixibat
- Drug: Livmarli — also filed as Maralixibat
Primary outcomes
what the primary-completion date above is the date OFIncidence of Long-Term Clinical Outcomes
measured Long-term clinical outcomes (SBD, LT, portal hypertension, all-cause mortality) up to 180 days after discontinuation of Livmarli will be recorded.
Liver Transplant Indication and Waitlist Status
measured LT waitlist status will be collected at enrollment and every 6 months for 5 years.
Assessment of Growth and Development
measured Weight (kilograms) and height (centimeters) z-scores will be collected every year for 5 years.
Incidence of Clinical Events Potentially Related to Fat-Soluble Vitamin Deficiencies and Their Long-Term Sequelae
measured The incidence of events will be assessed and reported every year for 5 years.
Permalink · MIRM's whole pipeline · Catalyst calendar · Every registered study · What changed