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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986036 Dose Level 1 | Experimental | Administered by subcutaneous injection. |
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| BMS-986036 Dose Level 2 | Experimental | Administered by subcutaneous injection. |
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| BMS-986036 Dose Level 3 | Experimental | Administered by subcutaneous injection. |
|
| Placebo | Placebo Comparator | Administered by subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24 | An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the NASH CRN Fibrosis Score at week 24 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). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0087 | Madison | Alabama | 35758 | United States | ||
| Local Institution - 0005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37088457 | Derived | 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. | |
| 36866389 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986036 10 mg | BMS-986036 10 mg administered subcutaneously once weekly |
| FG001 | BMS-986036 20 mg | BMS-986036 20 mg administered subcutaneously once weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2020 | Aug 16, 2022 |
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| Placebo | Other | Specified dose on specified days. |
|
| 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 | An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 24 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. | From first dose to 24 weeks after first dose |
| The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24 | An improvement in CPA is defined as any decrease in CPA at week 24 in liver biopsy. | 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 | The percentage of participants with NASH resolution without worsening of fibrosis at week 24 in liver biopsy. NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1. Worsening of fibrosis is defined as an increase of fibrosis by ≥ 1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). 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 |
| The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24 | NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 24 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). | From first dose to 24 weeks after first dose |
| The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24 | The percentage of participants with NASH improvement without worsening of fibrosis at week 24 in liver biopsy. NASH improvement defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥2 points with contribution from >1 NAS component. Worsening of fibrosis is defined as an increase of ≥1-point in the NASH Clinical Research Network (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 |
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24 | 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 24 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. 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 |
| The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24 | The percentage of participants with NASH improvement at week 24 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. | From first dose to 24 weeks after first dose |
| The Percentage of Participants With Progression to Cirrhosis at Week 24 | Progression to cirrhosis is defined by the nonalcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Stage 4 at Week 24 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). | From first dose to 24 weeks after first dose |
| 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 |
| Derived |
| Brown 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. |
| 33657443 | Derived | 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. |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| FG002 | BMS-986036 40 mg | BMS-986036 40 mg administered subcutaneously once weekly |
| FG003 | Placebo | Placebo matching BMS-986036 administered subcutaneously once weekly |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986036 10 mg | BMS-986036 10 mg administered subcutaneously once weekly |
| BG001 | BMS-986036 20 mg | BMS-986036 20 mg administered subcutaneously once weekly |
| BG002 | BMS-986036 40 mg | BMS-986036 40 mg administered subcutaneously once weekly |
| BG003 | Placebo | Placebo matching BMS-986036 administered subcutaneously once weekly |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24 | An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the NASH CRN Fibrosis Score at week 24 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 24 | An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 24 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24 | An improvement in CPA is defined as any decrease in CPA at week 24 in liver biopsy. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24 | The percentage of participants with NASH resolution without worsening of fibrosis at week 24 in liver biopsy. NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1. Worsening of fibrosis is defined as an increase of fibrosis by ≥ 1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). 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). | All treated participants | Posted | Number | Percentage Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24 | NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 24 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24 | The percentage of participants with NASH improvement without worsening of fibrosis at week 24 in liver biopsy. NASH improvement defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥2 points with contribution from >1 NAS component. Worsening of fibrosis is defined as an increase of ≥1-point in the NASH Clinical Research Network (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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24 | 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 24 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24 | The percentage of participants with NASH improvement at week 24 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
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| Secondary | The Percentage of Participants With Progression to Cirrhosis at Week 24 | Progression to cirrhosis is defined by the nonalcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Stage 4 at Week 24 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 24 weeks after first dose |
|
All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS-986036 10 mg | BMS-986036 10 mg administered subcutaneously once weekly | 1 | 49 | 3 | 49 | 36 | 49 |
| EG001 | BMS-986036 20 mg | BMS-986036 20 mg administered subcutaneously once weekly | 0 | 50 | 7 | 50 | 38 | 50 |
| EG002 | BMS-986036 40 mg | BMS-986036 40 mg administered subcutaneously once weekly | 0 | 49 | 6 | 49 | 39 | 49 |
| EG003 | BMS-986036 Placebo | Placebo matching BMS-986036 administered subcutaneously once weekly | 1 | 49 | 9 | 49 | 33 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2020 | Aug 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio (OR) |
| 1.89 |
| 2-Sided |
| 95 |
| 0.61 |
| 6.27 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.129 | Odds Ratio (OR) | 2.17 | 2-Sided | 95 | 0.71 | 7.10 | Superiority |
|
|
|
|
|
|
| Participants |
|
|
|
| OG003 | Placebo | Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Placebo |
Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|
Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|
Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|
|
|
|