A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal, Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/23/2019 |
Start Date: | May 4, 2018 |
End Date: | September 27, 2021 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
Email: | Clinical.Trials@bms.com |
Phone: | please email: |
A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
alcohol) and stage 3 liver fibrosis (severe fibrosis).
Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
alcohol) and stage 3 liver fibrosis (severe fibrosis).
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Liver biopsy performed within 6 months prior to the Screening Visit; if not performed
within 6 months prior to the Screening Visit, a liver biopsy will be performed during
the Screening Period and at least 4 weeks prior to randomization (Biopsy must be
consistent with NASH, with: a) A score of at least 1 for each NAS component
(steatosis, lobular inflammation, and ballooning), as assessed by the central reader
AND b) Stage 3 liver fibrosis according to the NASH CRN classification, as assessed by
the central reader
- Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must
have been on stable dosing regimens for at least 3 months prior to the Screening Visit
- Participants taking vitamin E at doses ≥800 IU/day must have been on stable doses for
at least 6 months prior to the Screening Visit (Vitamin E treatment must not have been
initiated after the liver biopsy was performed)
Exclusion Criteria:
- Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus
infection, chronic hepatitis C virus infection, autoimmune hepatitis, drug-induced
hepatotoxicity, Wilson disease, alpha-1-antitrypsin deficiency, iron overload, and
hemochromatosis)
- Current or past history of hepatocellular carcinoma (HCC)
- Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding,
hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver
transplantation
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
83
sites
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
3300 Gallows Road
Falls Church, Virginia 22042
Falls Church, Virginia 22042
(703) 776-4001
![Inova Fairfax Hospital](/wp-content/uploads/logos/inova-fairfax-hospital.jpg)
Phone: 703-776-3592
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
![Baylor College of Medicine](/wp-content/uploads/logos/baylor-college-of-medicine.png)
Phone: 713-798-1966
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
345 Saint Paul Place
Baltimore, Maryland 21202
Baltimore, Maryland 21202
Phone: 410-843-2075
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
3409 Worth Street
Dallas, Texas 75231
Dallas, Texas 75231
Phone: 146993031244514
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
![University of Texas Southwestern Medical Center](/wp-content/uploads/logos/university-of-texas-southwestern-medical-center.jpg)
Phone: 214-645-6188
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-2000
![Saint Luke's Hospital, Kansas City](/wp-content/uploads/logos/saint-luke-s-hospital-kansas-city.jpg)
Phone: 816-932-3623
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
5901 West Olympic Boulevard
Los Angeles, California 90036
Los Angeles, California 90036
Phone: 13239540400249
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
![Tulane University Health Sciences Center](/wp-content/uploads/logos/tulane-university-health-sciences-center.jpg)
Phone: 504-988-5763
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
70 Washington Square S
New York, New York 10012
New York, New York 10012
(212) 998-1212
![New York University](/wp-content/uploads/logos/new-york-university.jpg)
Phone: 646-501-4926
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
![Icahn School of Medicine at Mount Sinai](/wp-content/uploads/logos/icahn-school-of-medicine-at-mount-sinai.jpg)
Phone: 212-241-0493
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
734 Fairmount Avenue
Pasadena, California 91105
Pasadena, California 91105
Phone: 626-397-5820
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
![Thomas Jefferson University Hospital](/wp-content/uploads/logos/thomas-jefferson-university-hospital.png)
Phone: 215-955-7979
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Pittsburgh, Pennsylvania 15213
Phone: 412-235-1058
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1939 Roland Clarke Place
Reston, Virginia 20191
Reston, Virginia 20191
Phone: 571-281-1736
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
45 Castro Street
San Francisco, California 94114
San Francisco, California 94114
(415) 600-6000
![California Pacific Medical Center](/wp-content/uploads/logos/california-pacific-medical-center.jpg)
Phone: 415-600-6525
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)