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Showing 1–12 of 12 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LUM001 Clear all
Completed Phase 2 Interventional Results available

An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome

NCT02117713
View directory record Official record
Conditions
Alagille Syndrome
Interventions
LUM001 (Maralixibat)
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 18 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
10
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2021 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion

NCT02475317
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Placebo, Maralixibat, Volixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
84 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Apr 3, 2019 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

NCT02061540
View directory record Official record
Conditions
Primary Sclerosing Cholangitis (PSC)
Interventions
LUM001
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
5
States / cities
La Jolla, California • Sacramento, California • Aurora, Colorado + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 28, 2019 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

NCT01904058
View directory record Official record
Conditions
PBC, Primary Biliary Cirrhosis
Interventions
LUM001, Placebo, Ursodeoxycholic Acid
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
17
States / cities
La Jolla, California • Sacramento, California • Miami, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2019 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

NCT04168385
View directory record Official record
Conditions
Cholestatic Liver Disease
Interventions
Maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
6
States / cities
Los Angeles, California • Indianapolis, Indiana • Philadelphia, Pennsylvania + 3 more
Source: ClinicalTrials.gov public record
Updated Dec 7, 2025 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

NCT03905330
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis (PFIC)
Interventions
Maralixibat, Placebo
Drug · Other
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 17 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
11
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Orlando, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2023 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

NCT02057692
View directory record Official record
Conditions
Alagille Syndrome
Interventions
LUM001, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months to 18 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2019 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

NCT04524390
View directory record Official record
Conditions
Biliary Atresia
Interventions
Maralixibat, Placebo
Drug · Other
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
21 Days to 111 Days
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
7
States / cities
Phoenix, Arizona • Atlanta, Georgia • New York, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 18, 2025 · Synced Sep 4, 2026, 8:10 AM EDT
Active, not recruiting Phase 3 Interventional

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

NCT06553768
View directory record Official record
Conditions
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Interventions
Maralixibat, Placebo
Drug · Other
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
6 Months and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
9
States / cities
Los Angeles, California • Palo Alto, California • Chicago, Illinois + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

NCT04729751
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
Interventions
Maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
0 Days to 364 Days
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
7
States / cities
Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Sep 4, 2026, 8:10 AM EDT
Withdrawn Phase 2 Interventional

An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis

NCT02321306
View directory record Official record
Conditions
Primary Biliary Cirrhosis
Interventions
LUM001
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
13
States / cities
La Jolla, California • Sacramento, California • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 18, 2019 · Synced Sep 4, 2026, 8:10 AM EDT
Completed Phase 2 Interventional Results available

Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis

NCT02057718
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis (PFIC)
Interventions
LUM001 (Maralixibat)
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months to 18 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
5
States / cities
Los Angeles, California • Aurora, Colorado • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2023 · Synced Sep 4, 2026, 8:10 AM EDT