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Last Updated: July 16, 2024

CLINICAL TRIALS PROFILE FOR VOLIXIBAT


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Clinical Trials for Volixibat

Trial ID Title Status Sponsor Phase Summary
NCT02475317 ↗ 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 Completed Mirum Pharmaceuticals, Inc. Phase 1 The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.
NCT02475317 ↗ 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 Completed Shire Phase 1 The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.
NCT02787304 ↗ Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) Terminated Mirum Pharmaceuticals, Inc. Phase 2 The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
NCT02787304 ↗ Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) Terminated Shire Phase 2 The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
NCT04663308 ↗ A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Recruiting Mirum Pharmaceuticals, Inc. Phase 2 The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
NCT04718961 ↗ A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) Recruiting Mirum Pharmaceuticals, Inc. Phase 2 The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations.
NCT05050136 ↗ A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Recruiting Mirum Pharmaceuticals, Inc. Phase 2 The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Volixibat

Condition Name

Condition Name
Intervention Trials
Healthy Volunteers 1
Intrahepatic Cholestasis of Pregnancy 1
Non-Alcoholic Steatohepatitis 1
PBC 1
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Condition MeSH

Condition MeSH
Intervention Trials
Cholangitis 2
Non-alcoholic Fatty Liver Disease 1
Liver Cirrhosis, Biliary 1
Fatty Liver 1
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Clinical Trial Locations for Volixibat

Trials by Country

Trials by Country
Location Trials
United States 47
United Kingdom 8
Canada 5
New Zealand 2
Puerto Rico 1
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Trials by US State

Trials by US State
Location Trials
Texas 3
Mississippi 3
Florida 3
California 3
Tennessee 3
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Clinical Trial Progress for Volixibat

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase Trials
Phase 2 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase Trials
Recruiting 3
Terminated 1
Completed 1
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Clinical Trial Sponsors for Volixibat

Sponsor Name

Sponsor Name
Sponsor Trials
Mirum Pharmaceuticals, Inc. 5
Shire 2
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Sponsor Type

Sponsor Type
Sponsor Trials
Industry 7
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