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A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03486912
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).

Condition or disease Intervention/treatment Phase
Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis Drug: BMS-986036 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Compensated Liver Cirrhosis
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : January 9, 2020
Estimated Study Completion Date : April 5, 2021


Arm Intervention/treatment
Experimental: BMS-986036 Dose Level 1
Administered by subcutaneous injection
Drug: BMS-986036
Specified dose on specified days

Experimental: BMS-986036 Dose Level 2
Administered by subcutaneous injection
Drug: BMS-986036
Specified dose on specified days

Experimental: BMS-986036 Dose Level 3
Administered by subcutaneous injection
Drug: BMS-986036
Specified dose on specified days

Placebo Comparator: Placebo
Administered by subcutaneous injection
Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Proportion of participants who achieve ≥1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsy [ Time Frame: 48 weeks ]
  2. NASH Clinical Research Network (CRN) Fibrosis Score [Fibrosis measured on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal); 2 (perisinusoidal and portal/periportal); 3 (bridging fibrosis); 4 (cirrhosis)] [ Time Frame: 48 weeks ]
  3. NAFLD Activity Score (NAS) [NASH disease activity in the liver measured on a 0-8 scale: unweighted sum of steatosis, or fat (scale: 0-3), lobular inflammation (scale: 0-3), and hepatocellular ballooning (scale: 0-2)] [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
  2. Proportion of participants with a ≥ 1 stage improvement in fibrosis without worsening of NASH or NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
  3. Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy [ Time Frame: 48 weeks ]
  4. Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 48 weeks ]
  5. Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
  6. Number of adverse events (AE) [ Time Frame: Up to 52 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 and cirrhosis 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486912


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 93 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03486912     History of Changes
Other Study ID Numbers: MB130-069
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Digestive System Diseases