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ClinicalTrials.gov public records Last synced Oct 10, 2026, 1:01 PM EDT

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Showing 1–24 of 32 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: Mirum Pharmaceuticals, Inc. Clear all
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 8, 2025 · Synced Oct 10, 2026, 1:01 PM EDT
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 Jul 1, 2021 · Synced Oct 10, 2026, 1:01 PM EDT
Active, not recruiting No phase listed Observational

The REPLACE Registry for Cholbam® (Cholic Acid)

NCT03115086
View directory record Official record
Conditions
Bile Acid Synthesis Disorders
Interventions
Cholbam
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
55 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2039
U.S. locations
24
States / cities
Birmingham, Alabama • Palo Alto, California • San Francisco, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2026 · Synced Oct 10, 2026, 1:01 PM 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 27, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Completed No phase listed Observational

Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease

NCT02131623
View directory record Official record
Conditions
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Interventions
Not listed
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
5 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
4
States / cities
Phoenix, Arizona • Aurora, Colorado • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 18, 2019 · Synced Oct 10, 2026, 1:01 PM 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 11, 2023 · Synced Oct 10, 2026, 1:01 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379

NCT07712718
View directory record Official record
Conditions
Healthy Volunteers
Interventions
[14C]-MRM-3379
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
7 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Oct 7, 2026 · Synced Oct 10, 2026, 1:01 PM 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 29, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Terminated Phase 2 Interventional Results available

Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)

NCT02787304
View directory record Official record
Conditions
Non-Alcoholic Steatohepatitis
Interventions
SHP626, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
197 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
49
States / cities
Coronado, California • Fresno, California • Los Angeles, California + 42 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Approved For Marketing No phase listed Expanded access

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

NCT04530994
View directory record Official record
Conditions
Alagille Syndrome
Interventions
maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Months and older
U.S. locations
14
States / cities
Los Angeles, California • Redwood City, California • San Francisco, California + 11 more
Source: ClinicalTrials.gov public record
Updated Oct 20, 2021 · Synced Oct 10, 2026, 1:01 PM 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 4, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Completed Phase 3 Interventional Results available

Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis

NCT01438411
View directory record Official record
Conditions
Bile Acid Synthesis Defect
Interventions
Cholic Acid
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Oct 10, 2026, 1:01 PM 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 19, 2025 · Synced Oct 10, 2026, 1:01 PM EDT
Recruiting No phase listed Observational

Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)

NCT06193928
View directory record Official record
Conditions
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Interventions
Livmarli
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
8
States / cities
Los Angeles, California • Aurora, Colorado • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 8, 2026 · Synced Oct 10, 2026, 1:01 PM EDT
Recruiting Phase 2 Interventional

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

NCT07209462
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Low dose of MRM-3379, Middle Dose of MRM-3379, High dose of MRM-3379, Placebo, Low dose of MRM-3379 Open-Label
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
13 Years to 45 Years · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
15
States / cities
Phoenix, Arizona • Irvine, California • Orange, California + 12 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 10, 2026, 1:01 PM EDT
Terminated Phase 2 Interventional Results available

A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

NCT04718961
View directory record Official record
Conditions
Intrahepatic Cholestasis of Pregnancy
Interventions
Volixibat, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
7
States / cities
Birmingham, Alabama • New Haven, Connecticut • Miami, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2024 · Synced Oct 10, 2026, 1:01 PM 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 19, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Active, not recruiting Phase 2 Interventional

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

NCT05050136
View directory record Official record
Conditions
Primary Biliary Cholangitis, PBC
Interventions
Volixibat, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
333 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
44
States / cities
Coronado, California • Los Angeles, California • Sacramento, California + 38 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Oct 10, 2026, 1:01 PM EDT
Completed Phase 3 Interventional Results available

Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid

NCT00007020
View directory record Official record
Conditions
Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders, Cholestasis
Interventions
Cholic Acids
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1992 – 2009
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Oct 10, 2026, 1:01 PM EDT
Completed Phase 3 Interventional Results available

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

NCT04185363
View directory record Official record
Conditions
Progressive Familial Intrahepatic Cholestasis (PFIC)
Interventions
Maralixibat
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 18 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
10
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Orlando, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Oct 10, 2026, 1:01 PM 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 26, 2019 · Synced Oct 10, 2026, 1:01 PM EDT
Active, not recruiting Phase 2 Interventional

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

NCT04663308
View directory record Official record
Conditions
Primary Sclerosing Cholangitis
Interventions
Volixibat, Placebo
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
12 Years and older
Enrollment
182 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2028
U.S. locations
34
States / cities
Coronado, California • Los Angeles, California • Sacramento, California + 26 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Oct 10, 2026, 1:01 PM EDT
Active, not recruiting Phase 3 Interventional

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

NCT07298330
View directory record Official record
Conditions
Chronic Hepatitis D Infection
Interventions
Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 99 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
8
States / cities
Davis, California • Sacramento, California • San Francisco, California + 5 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Oct 10, 2026, 1:01 PM EDT
Completed Phase 3 Interventional Results available

Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

NCT01115582
View directory record Official record
Conditions
Inborn Errors of Bile Acid Synthesis
Interventions
Cholic acid
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
Not listed
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 3, 2023 · Synced Oct 10, 2026, 1:01 PM EDT