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CompletedNCT03486912FALCON 2Updated Oct 13, 2022Results posted

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

A Phase 2 interventional study of BMS-986036 and Placebo in Hepatic Cirrhosis, Liver Fibrosis and Nonalcoholic Fatty Liver Disease (NAFLD), sponsored by Bristol-Myers Squibb. Completed at 91 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hepatic Cirrhosis
  • Liver Fibrosis
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 and cirrhosis according to the NASH CRN classification, as assessed by the central reader
  • Must be 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

Exclusion criteria

Exclusion Criteria:

  • Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection [HCV], 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
  • Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy [EGD] performed within 12 months prior to the Screening Period has shown \<= Grade 1 varices

Other protocol-defined inclusion/exclusion criteria apply

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    BMS-986036 Dose Level 1

    Drug: BMS-986036

  • Experimental
    BMS-986036 Dose Level 2

    Drug: BMS-986036

  • Experimental
    BMS-986036 Dose Level 3

    Drug: BMS-986036

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugBMS-986036

    Specified dose on specified days.

    Also known as: Pegbelfermin

  • OtherPlacebo

    Specified dose on specified days.

05

What researchers measure

Primary outcomes

  1. The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48

    An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. 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.

    Time frame: From first dose to 48 weeks after first dose

Secondary outcomes

  1. The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48

    An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis.

    Time frame: From first dose to 48 weeks after first dose

  2. The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48

    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 48 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). 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).

    Time frame: From first dose to 48 weeks after first dose

  3. The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48

    An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. 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).

    Time frame: From first dose to 48 weeks after first dose

  4. The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48

    An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy.

    Time frame: From first dose to 48 weeks after first dose

  5. The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48

    NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2).

    Time frame: From first dose to 48 weeks after first dose

  6. The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48

    The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from \> 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8.

    Time frame: From first dose to 48 weeks after first dose

06

Results

Posted Oct 13, 2022

Participant flow

Randomized (Pre-Treatment)
Participant flow — Randomized (Pre-Treatment)
MilestoneBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
Started39383939
Completed39373939
Not completed0100
Withdrew: Withdrawal by subject0100
Treatment Period
Participant flow — Treatment Period
MilestoneBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
Started39373939
Completed35313434
Not completed4655
Withdrew: Withdrawal by subject3332
Withdrew: Other reasons0211
Withdrew: Adverse event0110
Withdrew: Lost to follow-up1002

Outcome measures

PrimaryThe Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48

An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. 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.

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 4828.224.328.230.8
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.773 · Odds ratio (or): 0.88 · 95% CI 0.30 to 2.62
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.544 · Odds ratio (or): 0.72 · 95% CI 0.23 to 2.23
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.811 · Odds ratio (or): 0.88 · 95% CI 0.30 to 2.62
SecondaryThe Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48

An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis.

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 4838.532.433.335.9
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.836 · Odds ratio (or): 1.12 · 95% CI 0.40 to 3.09
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.763 · Odds ratio (or): 0.86 · 95% CI 0.30 to 2.46
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.821 · Odds ratio (or): 0.89 · 95% CI 0.32 to 2.51
SecondaryThe Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48

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 48 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). 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).

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 4833.340.535.930.8
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.837 · Odds ratio (or): 1.13 · 95% CI 0.39 to 3.25
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.359 · Odds ratio (or): 1.53 · 95% CI 0.54 to 4.40
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.627 · Odds ratio (or): 1.26 · 95% CI 0.44 to 3.61
SecondaryThe Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48

An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. 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).

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 4835.929.728.233.3
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.864 · Odds ratio (or): 1.12 · 95% CI 0.40 to 3.16
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.743 · Odds ratio (or): 0.85 · 95% CI 0.29 to 2.49
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.630 · Odds ratio (or): 0.79 · 95% CI 0.27 to 2.29
SecondaryThe Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48

An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy.

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 4861.854.241.953.1
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.477 · Odds ratio (or): 1.43 · 95% CI 0.48 to 4.25
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.814 · Odds ratio (or): 1.04 · 95% CI 0.32 to 3.44
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.367 · Odds ratio (or): 0.64 · 95% CI 0.21 to 1.93
SecondaryThe Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48

NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2).

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 482.65.42.60.0
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.309
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.146
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.317
SecondaryThe Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48

The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from \> 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8.

Time frame:
From first dose to 48 weeks after first dose
Reported as:
Number · Percentage of Participants
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48
Percentage of ParticipantsBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 4815.424.312.82.6
Statistical analysis
  • BMS-986036 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.054 · Odds ratio (or): 6.91 · 95% CI 0.76 to 325.97
  • BMS-986036 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.004 · Odds ratio (or): 12.21 · 95% CI 1.50 to 549.08
  • BMS-986036 40 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.087 · Odds ratio (or): 5.59 · 95% CI 0.57 to 271.11

Adverse events

Collected over Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BMS-986036 10 mg1/39 (2.6%)7/39 (17.9%)27/39 (69.2%)
BMS-986036 20 mg0/38 (0%)7/37 (18.9%)36/37 (97.3%)
BMS-986036 40 mg0/39 (0%)8/39 (20.5%)29/39 (74.4%)
Placebo1/39 (2.6%)3/39 (7.7%)33/39 (84.6%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
Clostridium difficile infectionInfections and infestations0/390/372/390/39
Acute coronary syndromeCardiac disorders0/391/370/390/39
Coronary artery diseaseCardiac disorders1/391/370/390/39
HypophosphataemiaMetabolism and nutrition disorders0/391/370/390/39
Cerebral haemorrhageNervous system disorders0/391/370/390/39
Spondylitic myelopathyNervous system disorders0/391/370/390/39
UreterolithiasisRenal and urinary disorders0/391/370/390/39
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/391/370/390/39
Diaphragmatic paralysisRespiratory, thoracic and mediastinal disorders0/391/370/390/39
Drug eruptionSkin and subcutaneous tissue disorders0/391/370/390/39
Most frequent other events
Showing 10 of 68
Most frequent other events
EventBMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlacebo
DiarrhoeaGastrointestinal disorders2/3916/3711/396/39
NauseaGastrointestinal disorders1/3911/377/395/39
Injection site bruisingGeneral disorders2/397/373/394/39
Abdominal painGastrointestinal disorders0/396/372/393/39
Frequent bowel movementsGastrointestinal disorders3/396/375/390/39
FatigueGeneral disorders1/396/371/391/39
Increased appetiteMetabolism and nutrition disorders0/396/371/390/39
ArthralgiaMusculoskeletal and connective tissue disorders1/391/376/395/39
SinusitisInfections and infestations1/395/371/394/39
Injection site erythemaGeneral disorders1/391/375/392/39

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)BMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlaceboTotal
<=18 years00000
Between 18 and 65 years27303025112
>=65 years12891443
Sex: Female, Male
Sex: Female, Male(Participants)BMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlaceboTotal
Female2826212499
Male1112181556
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlaceboTotal
Hispanic or Latino13671137
Not Hispanic or Latino25303128114
Unknown or Not Reported12104
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BMS-986036 10 mgBMS-986036 20 mgBMS-986036 40 mgPlaceboTotal
American Indian or Alaska Native00000
Asian474318
Native Hawaiian or Other Pacific Islander00112
Black or African American10001
White30313433128
More than one race00000
Unknown or Not Reported40026
07

Study locations

91 sites
  • North Alabama Health Research, LLC
    Madison, Alabama 35758, United States
  • Local Institution - 0005
    Chandler, Arizona 85224, United States
  • Local Institution - 0088
    Phoenix, Arizona 85013, United States
  • Local Institution - 0006
    Phoenix, Arizona 85054, United States
  • Local Institution - 0090
    Tucson, Arizona 85712, United States
  • Local Institution - 0092
    Coronado, California 92118, United States
  • Kindred Medical Institute for Clinical Trials
    Corona, California 92879, United States
  • Local Institution - 0038
    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
  • Kaiser Permanente
    Oakland, California 94611, United States
  • Diverse Research Solutions
    Oxnard, California 93030, United States
  • Huntington Medical Research Institutes - HMRI Liver Center
    Pasadena, California 91105, United States
  • Local Institution - 0020
    Pasadena, California 91105, United States
  • Local Institution - 0073
    Redwood City, California 94063, United States
  • Local Institution - 0012
    Rialto, California 92377, United States
  • Local Institution - 0089
    San Clemente, California 92673, United States
  • Local Institution
    San Diego, California 92105, United States
  • Local Institution - 0014
    San Diego, California 92123, United States
  • Local Institution - 0068
    San Francisco, California 94115, United States
  • Local Institution - 0042
    Bridgeport, Connecticut 06610, United States
  • Local Institution
    Washington, District of Columbia 20007, United States
  • Local Institution - 0079
    Coral Gables, Florida 33134, United States
  • Top Medical Research
    Cutler Bay, Florida 33189, United States
  • Clinical Research of Homestead
    Homestead, Florida 33030, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Local Institution - 0001
    Lakewood Ranch, Florida 34211, United States
  • Local Institution - 0003
    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
  • Local Institution
    Tampa, Florida 33606, United States
  • Local Institution
    Atlanta, Georgia 30309, United States
  • Local Institution - 0108
    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 - 0026
    New Orleans, Louisiana 70121, United States
  • Local Institution - 0010
    Baltimore, Maryland 21202, United States
  • Local Institution - 0058
    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
  • Clinical Research Professionals
    Chesterfield, Missouri 63005, United States
  • Local Institution - 0031
    Kansas City, Missouri 64111, United States
  • Saint Louis University
    Saint Louis, Missouri 63110, United States
  • University at Buffalo
    Buffalo, New York 14203, United States
  • Northwell Health
    Manhasset, New York 11030, United States
  • Mount Sinai Hospital
    New York, New York 10003, United States
  • Local Institution - 0036
    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
  • Northeast GI Research Division
    Concord, North Carolina 28027, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Local Institution - 0009
    Philadelphia, Pennsylvania 19107, United States
  • Local Institution - 0004
    Pittsburgh, Pennsylvania 15213, United States
  • Local Institution
    Chattanooga, Tennessee 37421, United States
  • Local Institution - 0046
    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 - 0051
    Dallas, Texas 75203, United States
  • Local Institution - 0053
    Dallas, Texas 75234, United States
  • Texas Digestive Disease Consultants - Dallas
    Dallas, Texas 75246, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Local Institution - 0084
    Fort Worth, Texas 76104, United States
  • Local Institution - 0002
    Houston, Texas 77002, United States
  • Local Institution - 0057
    Houston, Texas 77030, United States
  • Local Institution - 0063
    Houston, Texas 77030, United States
  • Local Institution - 0028
    San Antonio, Texas 78215, United States
  • Local Institution - 0011
    San Antonio, Texas 78229, United States
  • Local Institution - 0102
    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 - 0050
    Richmond, Virginia 23298, United States
  • Kurume University Hospital
    Kurume, Fukuoka 8300011, Japan
  • Local Institution - 0055
    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
08

References and documents

Publications

  • Abdelmalek 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. PubMed 33657443 ↗

Study documents

  • Study protocol · Jan 30, 2020
  • Statistical analysis plan · Feb 20, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03486912
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Jun 12, 2018
Primary completion
Oct 8, 2020
Completion
Sep 14, 2021
Results posted
Oct 13, 2022
Last update
Oct 13, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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