Active, not recruiting

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

This study is no longer recruiting. Please check back for study results.

SHP626201Via Study LogoJPG

WHAT IS THE PURPOSE OF THIS STUDY?

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).

TRIAL AT A GLANCE

Condition

Non-Alcoholic Steatohepatitis

Study Intervention

SHP626 ; Placebo

Possibility of Active Treatment

75%

Study Type

Interventional

Phase

Phase 2

IS THIS STUDY RIGHT FOR ME?

AGE

18 to 80

Years

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Participation will consist of up to 10 visits to the study site. These visits will be completed over a screening period of up to 56 days, a 48-week treatment period, and a follow-up visit 4 weeks after treatment ends.

ENTRY CRITERIA

Presence of ≥ 5% steatosis (fat) on MRI

Confirmation of NASH without cirrhosis (fibrosis stage F1,2,or 3) from a liver biopsy. Must have a NAFLD Activity Score (NAS) of ≥4 with a score of at least 1 in each component (steatosis, lobular inflammation, and hepatocyte ballooning)

No additional liver diseases such as hepatitis C or alcoholic liver disease

If diabetes mellitus is present - must be well controlled - defined as HbA1c of < 9.5%

Study Locations

    • Canada
    • United Kingdom
    • United States of America

Enter your city or postal code to find a location near you.

RESULTS

  • 1.

    Carolinas Center for Liver Disease

    Statesville, North Carolina
    United States of America

    miles

  • 2.

    South Florida Center of Gastroenterology

    Wellington, Florida
    United States of America

    miles

  • 3.

    Inland Empire Liver Foundation

    Rialto, California
    United States of America

    miles

  • 4.

    Austin Center for Clinical Research

    Austin, Texas
    United States of America

    miles

  • 5.

    Quality Medical Research

    Nashville, Tennessee
    United States of America

    miles

  • 6.

    South Denver Gastroenterology, PC

    Englewood, CO
    United States of America

    miles

  • 7.

    Clinsearch, LLC

    Chattanooga, TN
    United States of America

    miles

  • 8.

    Mercy Medical Center

    Baltimore, MD
    United States of America

    miles

  • 9.

    LAIR Centre

    Vancouver, British Columbia
    Canada

    miles

  • 10.

    Gastrointestinal Specialists of Georgia

    Marietta, Georgia
    United States of America

    miles

  • 11.

    California Liver Research Institute

    Pasadena, California
    United States of America

    miles

  • 12.

    Digestive Disease Associates

    Catonsville, MD
    United States of America

    miles

  • 13.

    University of Calgary Liver Unit

    Calgary, Alberta
    Canada

    miles

  • 14.

    Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia
    Canada

    miles

  • 15.

    Cumberland Research Associates, LLC

    Fayetteville, NC
    United States of America

    miles

  • 16.

    University of Mississippi Medical Center

    Jackson, MS
    United States of America

    miles

  • 17.

    Concorde Medical Group PLLC

    New York, New York
    United States of America

    miles

  • 18.

    Schiff Center for Liver Diseases

    Miami, FL
    United States of America

    miles

  • 19.

    DHAT Research Institute

    Richardson, TX
    United States of America

    miles

  • 20.

    UVM Medical Center

    Burlington, VT
    United States of America

    miles

  • 21.

    Southern California Research Center

    Coronado, CA
    United States of America

    miles

  • 22.

    University of Rochester Medical Center

    Rochester, NY
    United States of America

    miles

  • 23.

    University of Pittsburgh Medical Center

    Pittsburgh, PA
    United States of America

    miles

  • 24.

    Northwell Health Inc.

    Manhasset, NY
    United States of America

    miles

  • 25.

    Henry Ford Health System

    Novi, MI
    United States of America

    miles

  • 26.

    Toronto Liver Centre

    Toronto, Ontario
    Canada

    miles

  • 27.

    Kansas City Research Institute

    Kansas City, MO
    United States of America

    miles

  • 28.

    Fresno Clinical Research Center

    Fresno, CA
    United States of America

    miles

  • 29.

    John Radcliffe Hospital

    Oxford, Oxfordshire
    United Kingdom

    miles

  • 30.

    Liver Research Center

    Louisville, KY
    United States of America

    miles

  • 31.

    DUMC-Gastroenterology

    Durham, NC
    United States of America

    miles

  • 32.

    Internal Medicine Associates of Wellstar Atlanta Medical

    Atlanta, GA
    United States of America

    miles

  • 33.

    Bon Secours Liver Institute of Virginia

    Richmond, VA
    United States of America

    miles

  • 34.

    University of Massachusetts Medical School

    Worcester, MA
    United States of America

    miles

  • 35.

    University of Iowa Hospitals and Clinics

    Iowa City, IA
    United States of America

    miles

  • 36.

    Dartmouth Hitchcock Medical Center

    Lebanon, NH
    United States of America

    miles

  • 37.

    Louisiana Research Center, LLC

    Shreveport, LA
    United States of America

    miles

  • 38.

    Ceders-Sinai Medical Center

    Los Angeles, CA
    United States of America

    miles

  • 39.

    Nova Scotia Heath Authority

    Halifax, Nova Scotia
    Canada

    miles

  • 40.

    CRCHUM

    Montreal, Quebec
    Canada

    miles

  • 41.

    Norfolk & Norwich University Hospital

    Norwich, Norfolk
    United Kingdom

    miles

  • 42.

    NHS Tayside

    Taysdie, Dundee City
    United Kingdom

    miles

  • 43.

    Abertawe Bro Morgannwg University

    Swansea, Swansea
    United Kingdom

    miles

  • 44.

    Royal Free Hospital

    Hampstead, London
    United Kingdom

    miles

  • 45.

    Nottingham Digestive Diseases Centre and Biomedical Research Unit

    Nottingham, Nottingham
    United Kingdom

    miles

  • 46.

    York Clinical Research Facility

    York, York
    United Kingdom

    miles

  • 47.

    University Hospital Birmingham

    West Midlands, Birmingham
    United Kingdom

    miles

  • 48.

    Royal London Hospital

    London,
    United Kingdom

    miles

  • 49.

    Digestive and Liver Disease Specialists

    Norfolk, VA
    United States of America

    miles

  • 50.

    Emory University

    Atlanta, GA
    United States of America

    miles

  • 51.

    George Washington (GW) Medical Faculty Associates

    Washington, District of Columbia
    United States of America

    miles

  • 52.

    Baylor College of Medicine – Advanced Liver Therapies

    Houston, TX
    United States of America

    miles

  • 53.

    Center for Liver Disease

    Charlotte, NC
    United States of America

    miles

  • 54.

    The Queen’s Medical Center – Liver Center

    Honolulu, HI
    United States of America

    miles

  • 55.

    Tulane University Health Sciences Center

    New Orleans, LA
    United States of America

    miles

  • 56.

    UPR: Medical Sciences Campus

    San Juan, Puerto Rico
    Puerto Rico

    miles

  • 57.

    Medical University of South Carolina

    Charleston, SC
    United States of America

    miles

  • 58.

    Methodist Health Systems Clinical

    Dallas, TX
    United States of America

    miles

  • 59.

    UW Digestive Health Center (DHC)

    Madison, WI
    United States of America

    miles

  • 60.

    University of TN Health Science Center

    Memphis, TN
    United States of America

    miles

  • 61.

    Beth Israel Deaconess Medical Center

    Boston, MA
    United States of America

    miles

  • 62.

    McGuire VA Medical Center

    Richmond, VA
    United States of America

    miles

  • 63.

    Virginia Mason Medical Center

    Seattle, WA
    United States of America

    miles

  • 64.

    Texas Children’s Hospital

    Houston, TX
    United States of America

    miles

  • 65.

    Medstar Georgetown University Hospital

    Washington, District of Columbia
    United States of America

    miles