A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
FALCON 1
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
1 other identifier
interventional
197
2 countries
89
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 stage 3 liver fibrosis (severe fibrosis).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Typical duration for phase_2
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2021
CompletedResults Posted
Study results publicly available
September 9, 2022
CompletedSeptember 9, 2022
August 1, 2022
2.2 years
March 30, 2018
August 16, 2022
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24
The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 24 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
From first dose to 24 weeks after first dose
Secondary Outcomes (9)
The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24
From first dose to 24 weeks after first dose
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 24
From first dose to 24 weeks after first dose
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24
From first dose to 24 weeks after first dose
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24
From first dose to 24 weeks after first dose
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24
From first dose to 24 weeks after first dose
- +4 more secondary outcomes
Study Arms (4)
BMS-986036 Dose Level 1
EXPERIMENTALAdministered by subcutaneous injection.
BMS-986036 Dose Level 2
EXPERIMENTALAdministered by subcutaneous injection.
BMS-986036 Dose Level 3
EXPERIMENTALAdministered by subcutaneous injection.
Placebo
PLACEBO COMPARATORAdministered by subcutaneous injection.
Interventions
Specified dose on specified days.
Eligibility Criteria
You may qualify if:
- Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. 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 regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
- Participants taking vitamin E at doses greater than or equal to (\>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (\>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed.
You may not qualify if:
- Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus \[HCV\] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Local Institution - 0087
Madison, Alabama, 35758, United States
Local Institution - 0005
Chandler, Arizona, 85224, United States
Local Institution - 0088
Phoenix, Arizona, 85013, United States
Local Institution - 0001
Phoenix, Arizona, 85054, United States
The Institute for Liver Health - Tucson
Tucson, Arizona, 85712, United States
Kindred Medical Institute for Clinical Trials
Corona, California, 92879, United States
Local Institution - 0092
Coronado, California, 92118, United States
University of California San Diego
La Jolla, California, 92037, United States
Local Institution - 0017
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
GastroIntestinal Biosciences
Los Angeles, California, 90067-2015, United States
Catalina Research Institute
Montclair, California, 91763, United States
Local Institution - 0008
Oakland, California, 94611, United States
Local Institution - 0044
Oxnard, California, 93030, United States
Huntington Medical Research Institutes - HMRI Liver Center
Pasadena, California, 91105, United States
Local Institution - 0019
Pasadena, California, 91105, United States
Local Institution - 0074
Redwood City, California, 94063, United States
Local Institution - 0013
Rialto, California, 92377, United States
Local Institution - 0089
San Clemente, California, 92673, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Local Institution - 0068
San Francisco, California, 94115, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Local Institution - 0079
Coral Gables, Florida, 33134, United States
Top Medical Research
Cutler Bay, Florida, 33189, United States
Local Institution - 0100
Gainesville, Florida, 32610, United States
Clinical Research of Homestead
Homestead, Florida, 33030, United States
Local Institution - 0082
Jacksonville, Florida, 32224, United States
Local Institution - 0003
Lakewood Rch, Florida, 34211, United States
Local Institution - 0002
Miami, Florida, 33136, United States
A+ Research
Miami, Florida, 33144, United States
IMIC Research
Miami, Florida, 33157, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Local Institution - 0081
Orlando, Florida, 32806, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Local Institution - 0105
Marietta, Georgia, 30060, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Local Institution - 0027
New Orleans, Louisiana, 70121, United States
Local Institution - 0007
Baltimore, Maryland, 21202, United States
Local Institution - 0057
Catonsville, Maryland, 21228, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Local Institution - 0063
Chesterfield, Missouri, 63005, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University at Buffalo
Buffalo, New York, 14203, United States
Local Institution - 0078
Manhasset, New York, 11030, United States
Local Institution - 0083
New York, New York, 10003, United States
Local Institution - 0038
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Local Institution - 0067
Butner, North Carolina, 27509-1626, United States
Local Institution - 0064
Charlotte, North Carolina, 28204, United States
Local Institution - 0096
Concord, North Carolina, 28027, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0009
Philadelphia, Pennsylvania, 19107, United States
Local Institution - 0006
Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 0047
Germantown, Tennessee, 38138, United States
Local Institution - 0041
Hermitage, Tennessee, 37076, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5280, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Local Institution - 0066
Austin, Texas, 78757, United States
Local Institution - 0053
Dallas, Texas, 75203, United States
Local Institution - 0052
Dallas, Texas, 75234, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-88520, United States
Texas Digestive Disease Consultants - Southlake
Fort Worth, Texas, 76104, United States
Local Institution - 0004
Houston, Texas, 77002, United States
Local Institution - 0059
Houston, Texas, 77030, United States
Local Institution - 0062
Houston, Texas, 77030, United States
Local Institution - 0029
San Antonio, Texas, 78215, United States
Local Institution - 0012
San Antonio, Texas, 78229, United States
Local Institution - 0101
San Antonio, Texas, 78229, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Gastroenterology Associates, PC
Manassas, Virginia, 20110, United States
Local Institution - 0069
Norfolk, Virginia, 23502, United States
The Gastroenterology Group
Reston, Virginia, 20191, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
Local Institution - 0077
Richmond, Virginia, 23249, United States
Local Institution - 0049
Richmond, Virginia, 23298, United States
Kurume University Hospital
Kurume, Fukuoka, 8300011, Japan
Local Institution - 0056
Yokohama, Kanagawa, 236-0004, Japan
Local Institution - 0072
Kashihara, Nara, 6348522, Japan
Toranomon Hospital
Minato, Tokyo, 105-8470, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 1600016, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Related Publications (3)
Loomba R, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Harrison SA, Lawitz EJ, Gunn N, Imajo K, Ravendhran N, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Abdelmalek MF. Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Stage 3 Fibrosis (FALCON 1): A Randomized Phase 2b Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):102-112.e9. doi: 10.1016/j.cgh.2023.04.011. Epub 2023 Apr 23.
PMID: 37088457DERIVEDBrown EA, Minnich A, Sanyal AJ, Loomba R, Du S, Schwarz J, Ehman RL, Karsdal M, Leeming DJ, Cizza G, Charles ED. Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial. JHEP Rep. 2023 Jan 7;5(4):100661. doi: 10.1016/j.jhepr.2022.100661. eCollection 2023 Apr.
PMID: 36866389DERIVEDAbdelmalek MF, Charles ED, Sanyal AJ, Harrison SA, Neuschwander-Tetri BA, Goodman Z, Ehman RA, Karsdal M, Nakajima A, Du S, Tirucherai GS, Klinger GH, Mora J, Yamaguchi M, Shevell DE, Loomba R. The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis. Contemp Clin Trials. 2021 May;104:106335. doi: 10.1016/j.cct.2021.106335. Epub 2021 Feb 28.
PMID: 33657443DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 3, 2018
Study Start
June 19, 2018
Primary Completion
September 14, 2020
Study Completion
August 17, 2021
Last Updated
September 9, 2022
Results First Posted
September 9, 2022
Record last verified: 2022-08