Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:2/2/2019
Start Date:September 2015
End Date:October 2022
Contact:Carol Parish
Email:carol.parish@interceptpharma.com
Phone:+44 203 872 5027

Use our guide to learn which trials are right for you!

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment
compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in
patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.


Inclusion Criteria:

1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than
6 months before Day 1 defined by presence of all 3 key histological features of NASH
according to NASH CRN criteria.

2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring
of fibrosis, or

Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the
following risk factors:

- Obesity (BMI ≥30 kg/m2)

- Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria

- ALT >1.5× upper limit of normal (ULN).

3. For subjects with a historical biopsy, is either not taking or is on stable doses of
TZDs/glitazones or vitamin E for 6 months before Day 1.

4. Stable body weight.

Exclusion Criteria:

1. Model for End-stage Liver Disease (MELD) score >12

2. ALT ≥10× ULN

3. HbA1c >9.5%

4. Total bilirubin >1.5 mg/dL

5. Evidence of other known forms of known chronic liver disease such as alcoholic liver
disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
suspected hepatocellular carcinoma (HCC)

6. History of liver transplant, or current placement on a liver transplant list

7. Current or history of significant alcohol consumption

8. Prior or planned ileal resection, or prior or planned bariatric surgery

9. Histological presence of cirrhosis

10. History of biliary diversion

11. Known positivity for human immunodeficiency virus infection.

12. Acute cholecystitis or acute biliary obstruction.

13. BMI >45 kg/m2
We found this trial at
200
sites
Saint Louis, Missouri 63104
Principal Investigator: Brent Tetri, MD
Phone: 314-977-9400
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Ashwani Singal, MD
Phone: 205-975-4016
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Kathleen Corey, MD
Phone: 617-724-3836
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Michelle Lai, MD, MPH
Phone: 617-632-1068
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Samuel H Sigal, MD
Phone: 347-671-8216
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: A. Sidney Barritt, MD
Phone: 919-843-5936
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Andrew S deLemos, MD
Phone: 704-355-4875
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: K. Gautham Reddy, MD
Phone: 773-702-2788
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Nila Rafiq, MD
Phone: 703-776-2056
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Moises Nevag Rubin, MD
Phone: 713-500-6654
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Brian B Borg, MD
Phone: 601-815-5180
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Maria Yataco, MD
Phone: 904-953-8030
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Ana M Corregidor, MD
Phone: 904-680-0871
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Vinay Sundaram, MD
Phone: 310-423-4295
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: David E Bernstein, MD
Phone: 516-562-2060
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: John Lake, MD
Phone: 612-624-5773
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Jonathan Huang, MD
Phone: 585-275-0803
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Kiran Bambha, MD
Phone: 206-543-0826
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: John Rivas, MD
Phone: 954-659-5888
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
?
mi
from
Weston, FL
Click here to add this to my saved trials
Adelaide,
Principal Investigator: John Bate, Dr
Phone: +61 8 8222 4248
?
mi
from
Adelaide,
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Principal Investigator: Antoine Jakiche, MD
Phone: 505-872-4091
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Annapolis, Maryland 21401
Principal Investigator: Michael S Epstein, MD
Phone: 410-224-4887
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Arlington, Texas 76012
Principal Investigator: Reem Ghalib, MD
Phone: 817-471-1070
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
Principal Investigator: Adam S Zivony, MD
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Jeffrey M Williams, MD
Phone: 706-461-5454
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30308
Principal Investigator: Norman Gitlin, MD
Phone: 404-881-1094
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Raymond A Rubin, MD
Phone: 404-605-2347
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Ryan Ford, MD
Phone: 404-712-1816
Emory University Hospital As the largest health care system in Georgia and the only health...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Michael R Galambos, MD
Phone: 678-686-5073
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: Sandeep Khurana, MBBS
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
?
mi
from
Augusta, GA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Amanda Wieland, MD
Phone: 303-724-8892
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78756
Principal Investigator: Imtiaz Alam, MD
Phone: 512-371-7702
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21202
Principal Investigator: Paul Thuluvath, MD
Phone: 410-843-2075
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21287
Principal Investigator: James Hamilton, MD
Phone: 410-955-9695
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Dawn Torres, MD
Phone: 301-295-6127
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Michelle Long, MD
Phone: 617-638-6527
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bowling Green, Kentucky 42101
Principal Investigator: Robert Emslie, MD
Phone: 270-780-0591
?
mi
from
Bowling Green, KY
Click here to add this to my saved trials
Bridgeport, Connecticut 06610
Principal Investigator: Caroline Loeser, MD
Phone: 203-384-4849
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Brockton, Massachusetts 02302
Principal Investigator: Prithvi Sreenivasan, MD
Phone: 508-588-9900
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Buffalo, New York 14215
Principal Investigator: Andrew Talal, MD
Phone: 716-878-3320
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burlington, Massachusetts 01805
Principal Investigator: Fredric Gordon, MD
?
mi
from
Burlington, MA
Click here to add this to my saved trials
Burlington, Vermont 05405
Principal Investigator: Steven Lidofsky, MD, PhD
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Catonsville, Maryland 21228
Principal Investigator: Natarajan Ravendhran, MD
Phone: 410-737-0053
?
mi
from
Catonsville, MD
Click here to add this to my saved trials
1955 West Frye Road
Chandler, Arizona 85224
Principal Investigator: Richard Manch, MD
Phone: 602-406-2147
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Ira Willner, MD
Phone: 843-876-4301
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
Principal Investigator: Jason Wilson, MD
Phone: 704-602-6564
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Stephen Caldwell, MD
Phone: 434-982-0709
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Principal Investigator: Richard A Krause, MD
Phone: 423-698-4584
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60611
Principal Investigator: Mary E Rinella, MD
Phone: 312-694-0326
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nikunj Shah, MD
Phone: 312-563-3919
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91911
Principal Investigator: Michael Water, MD
Phone: 619-955-5246
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Chula Vista, California 91910
Principal Investigator: Cynthia L Schaeffer, MD
Phone: 619-861-5314
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Chula Vista, California 91910
Principal Investigator: Gregory Wiener, MD
Phone: 619-585-8882
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Principal Investigator: Ravi Ravinuthala, MD
Phone: 513-587-0410
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45267
Principal Investigator: Kenneth E Sherman, MD, PhD
Phone: 513-584-2363
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44194
Principal Investigator: Pierre Gholam, MD
Phone: 216-286-6668
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Hicham Khallafi, MD
Phone: 216-778-5278
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Georgia 31904
Principal Investigator: Michael Steinbook, MD
Phone: 706-321-0495
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: David Bradley, MD
Phone: 614-688-6257
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Coronado, California 92118
Principal Investigator: Tarek Hassanein, MD
Phone: 619-522-0330
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Dallas, Texas 75203
Principal Investigator: Parvez Mantry, MD
Phone: 214-947-1287
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: James Trotter, MD
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Marlyn Mayo, MD
Phone: 214-648-2725
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75234
Principal Investigator: Abdullah Mubarak, MD
Phone: 972-354-1520
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Stuart C Gordon, MD
Phone: 313-916-3369
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Doral, Florida 33166
Principal Investigator: Linda Martinez, MD
Phone: 305-552-7660
?
mi
from
Doral, FL
Click here to add this to my saved trials
Dothan, Alabama 36305
Principal Investigator: William McLaughlin, MD
Phone: 919-781-2514
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
Principal Investigator: Victor Araya, MD
Phone: 215-345-2517
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Manal F Abdelmalek, MD, MPH
Phone: 919-684-4798
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
Principal Investigator: John J Santoro, DO
Phone: 609-407-1220
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
El Cajon, California 92020
Principal Investigator: Donald Lipkis, MD
Phone: 619-334-4735
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
El Paso, Texas 79935
Principal Investigator: Ruben Ramirez-Vega, MD
Phone: 915-307-4669
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Englewood, Colorado 80113
Principal Investigator: Marcelo Kugelmas, MD
Phone: 303-406-4288
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
Principal Investigator: John E Poulos, MD
Phone: 910-484-8163
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
Principal Investigator: Angelo Paredes, MD
Phone: 210-916-2746
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Apurva A Modi, MD
Phone: 817-922-2585
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California 93701
Principal Investigator: Bakht Roshan, MD
Phone: 559-499-6637
?
mi
from
Fresno, CA
Click here to add this to my saved trials
7055 North Maple Avenue
Fresno, California 93720
Principal Investigator: Muhammad Sheikh, MD
Phone: 559-393-6999
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Gainesville, Florida 32610
Principal Investigator: Roberto J Firpi-Morell, MD
Phone: 352-273-9470
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Ziad Younes, MD
Phone: 901-309-6030
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Glendora, California 91740
Principal Investigator: Sartaj Marty Arora, MD
Phone: 714-726-7225
?
mi
from
Glendora, CA
Click here to add this to my saved trials
Greenville, South Carolina 29615
Principal Investigator: Gary Abrams, MD
Phone: 864-455-2846
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hamden, Connecticut 06518
Principal Investigator: Paul Feuerstadt, MD
Phone: 203-281-5161
?
mi
from
Hamden, CT
Click here to add this to my saved trials
200 Medical Center Drive
Hazard, Kentucky 41701
Principal Investigator: Uday Shankar, MD
?
mi
from
Hazard, KY
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
Principal Investigator: Karen Krok, MD
Phone: 717-531-5226
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Honolulu, Hawaii 96813
Principal Investigator: Naoky Tsai, MD
Phone: 808-691-1163
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Maya Balakrishnan, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: John M Vierling, MD
Phone: 713-798-5382
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Victor Ankoma-Sey, MD
Phone: 713-799-2667
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77021
Principal Investigator: Hashem El-Serag, MD
Phone: 713-440-4403
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: David W Victor, III, MD
Phone: 713-441-6316
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77062
Principal Investigator: Joe E Pouzar, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77004
Principal Investigator: Andrea Duchini, MD
Phone: 832-526-3597
?
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Larry C Evans, DO
Phone: 208-528-4256
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Indianapolis, Indiana 46237
Principal Investigator: David C Pound, MD
Phone: 317-865-2959
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
550 University Boulevard
Indianapolis, Indiana 46202
Principal Investigator: Raj Vuppalanchi, MD
Phone: 317-278-6266
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Inverness, Florida 34452
Principal Investigator: Paul A Hellstern, Jr, MD
Phone: 352-341-2100
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jacksonville, Florida 32209
Principal Investigator: James Scolapio, MD
Phone: 904-633-0070
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Winston Dunn, MD
Phone: 913-945-7830
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
Principal Investigator: Bradley Freilich, MD
Phone: 816-759-5274
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64128
Principal Investigator: Prashant Pandya, DO
Phone: 816-861-4700
?
mi
from
Kansas City, MO
Click here to add this to my saved trials