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

NCT02787304 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2019-11-25

Study results available
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Summary

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).

Conditions

  • Non-Alcoholic Steatohepatitis

Interventions

DRUG

SHP626

5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Mirum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-24
Primary Completion
2018-07-27
Completion
2018-07-27

Countries

  • United States
  • Canada
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787304 on ClinicalTrials.gov