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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 liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986036 Dose Level 1 | Experimental |
| |
| BMS-986036 Dose Level 2 | Experimental |
| |
| BMS-986036 Dose Level 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose to 48 weeks after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Health Research, LLC | Madison | Alabama | 35758 | United States | ||
| Local Institution - 0005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37088458 | Derived | Abdelmalek MF, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Lawitz EJ, Harrison SA, Jacobson IM, Imajo K, Gunn N, Halegoua-DeMarzio D, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Loomba R. Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Compensated Cirrhosis (FALCON 2): A Randomized Phase 2b Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):113-123.e9. doi: 10.1016/j.cgh.2023.04.012. Epub 2023 Apr 23. | |
| 33657443 |
| 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 | |||||
|---|---|---|---|---|---|---|---|
| Randomized (Pre-Treatment) |
|
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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 22, 2022 |
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| Placebo | Other | Specified dose on specified days. |
|
| From first dose to 48 weeks after first dose |
| 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). | From first dose to 48 weeks after first dose |
| 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). | From first dose to 48 weeks after first dose |
| 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. | From first dose to 48 weeks after first dose |
| 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). | From first dose to 48 weeks after first dose |
| 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. | From first dose to 48 weeks after first dose |
| 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 |
| Kindred Medical Institute for Clinical Trials | Corona | California | 92879 | United States |
| Local Institution - 0092 | Coronado | California | 92118 | 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 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 |
| Clinical Research of Homestead | Homestead | Florida | 33030 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Local Institution - 0001 | Lakewood Rch | 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 | St 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 |
| 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 | Moved to treatment period |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
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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 |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 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 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
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| Secondary | 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
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| Secondary | 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
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| Secondary | 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
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| Secondary | 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). | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
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| Secondary | 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. | All treated participants | Posted | Number | Percentage of Participants | From first dose to 48 weeks after first dose |
|
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).
All-cause mortality was assessed for all randomized participants. SAEs and Other AEs were assessed for all treated participants.
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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 | 39 | 7 | 39 | 27 | 39 |
| EG001 | BMS-986036 20 mg | BMS-986036 20 mg administered subcutaneously once weekly | 0 | 38 | 7 | 37 | 36 | 37 |
| EG002 | BMS-986036 40 mg | BMS-986036 40 mg administered subcutaneously once weekly | 0 | 39 | 8 | 39 | 29 | 39 |
| EG003 | Placebo | Placebo matching BMS-986036 administered subcutaneously once weekly | 1 | 39 | 3 | 39 | 33 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Flatulence | 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 |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| 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 reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Respiratory tract infection | 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 |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 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 |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | 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 |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary 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 |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue 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 |
| |
| Skin lesion | 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 | Feb 20, 2021 | Aug 22, 2022 | SAP_001.pdf |
Not provided
| 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
| Other Reasons |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| 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) |
| 0.72 |
| 2-Sided |
| 95 |
| 0.23 |
| 2.23 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.811 | Odds Ratio (OR) | 0.88 | 2-Sided | 95 | 0.30 | 2.62 | Superiority |
|
|
|
| OG003 |
| Placebo |
Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Placebo matching BMS-986036 administered subcutaneously once weekly |
|
|
|