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The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group D: | Experimental | Administered as specified on specified days |
|
| Treatment Group E: | Placebo Comparator | Administered as specified on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | BMS-986036 20 mg QD |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement. | From Day 1 to Day 112 |
| Number of Participants With Adverse Events (AEs) | The number of participants with on-study AEs was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Serious Adverse Events (SAEs) | The number of participants with on-study SAEs was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Injection Site Reactions | The number of participants with on-study injection site reactions was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Adverse Events Leading to Discontinuation | The number of participants with on-study AEs leading to discontinuation was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Deaths | The number of deaths was reported for each arm. | From first dose to date of last dose plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm. | From Day 1 to Day 112 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States | ||
| Texas Liver Institute |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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3 participants were enrolled, randomized and treated within this sub-study (PK cohort).
Note: parent study is NCT02413372 (MB130-045).
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| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986036 20 mg QD | Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting |
| FG001 | Placebo 20 mg QD | Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
| |||||||||||||
| Follow-up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986036 20 mg QD | Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting |
| BG001 | Placebo 20 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement. | All treated participants Note: data not reported due to privacy reasons | Posted | Mean | 90% Confidence Interval | percentage | From Day 1 to Day 112 |
|
Non-serious adverse events after first dose of study medication and within 7 days of last dose and serious adverse events after first dose of study medication and within 30 days of last dose (approximately 4 months).
data not reported due to privacy reasons
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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 20 mg QD | Participants self-administered 20 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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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 | Jun 3, 2016 | Jan 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2017 | Jan 16, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
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| Drug |
Placebo QD |
|
| Number of Participants With Marked Laboratory Abnormalities | The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Vital Sign Abnormalities | The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm. | From first dose to date of last dose plus 30 days |
| Number of Participants With Physical Examination Abnormalities | The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm. | From first dose to date of last dose plus 30 days |
| Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | The mean percent change in bone mineral density from baseline to day 112 reported for each arm. | From Day 1 to Day 112 |
| Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 |
Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm. |
| From Day 1 to Day 142 |
| Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm. | From Day 1 to Day 142 |
| San Antonio |
| Texas |
| 78215 |
| United States |
| NOT COMPLETED |
|
Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Age categorization | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo 20 mg QD |
Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting. |
|
|
| Primary | Number of Participants With Adverse Events (AEs) | The number of participants with on-study AEs was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | The number of participants with on-study SAEs was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Injection Site Reactions | The number of participants with on-study injection site reactions was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | The number of participants with on-study AEs leading to discontinuation was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Deaths | The number of deaths was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Marked Laboratory Abnormalities | The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Vital Sign Abnormalities | The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Number of Participants With Physical Examination Abnormalities | The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From first dose to date of last dose plus 30 days |
|
|
|
| Primary | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | The mean percent change in bone mineral density from baseline to day 112 reported for each arm. | All treated participants with DXA data at baseline and 6 months Note: data not reported due to privacy reasons | Posted | Mean | Standard Deviation | Percentage | From Day 1 to Day 112 |
|
|
|
| Secondary | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | From Day 1 to Day 112 |
|
|
|
| Secondary | Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From Day 1 to Day 142 |
|
|
|
| Secondary | Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm. | All treated participants Note: data not reported due to privacy reasons | Posted | Number | Participants | From Day 1 to Day 142 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo 20 mg QD | Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Injection Site Reaction |
|
| Injection Site Pain |
|
| Injection Site Rash |
|
| Injection Site Swelling |
|
| QT > 500 msec |
|
| QTcF > 450 msec |
|
| QT change from baseline > 30 msec |
|
| QTcF change from baseline > 30 msec |
|