Non-Alcoholic Steatohepatitis
Conditions
Keywords
First Line Therapy, NASH
Brief summary
The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).
Interventions
DRUGBMS-986036
DRUGPlacebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or female between 21 and 75 years old * Body Mass Index (BMI) of 25 or more
Exclusion criteria
* Chronic Liver disease other than NASH * Uncontrolled diabetes * Any major surgery within 6 weeks of screening * Unable to self-administer under the skin injections * Any bone trauma, fracture or bone surgery within 8 weeks of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | From Day 1 to Day 112 | The mean percent change in bone mineral density from baseline to day 112 reported for each arm. |
| Number of Participants With Vital Sign Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm. |
| Number of Participants With Physical Examination Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm. |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | From Day 1 to Day 112 | 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. |
| Number of Participants With Adverse Events (AEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study AEs was reported for each arm. |
| Number of Participants With Serious Adverse Events (SAEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study SAEs was reported for each arm. |
| Number of Participants With Injection Site Reactions | From first dose to date of last dose plus 30 days | The number of participants with on-study injection site reactions was reported for each arm. |
| Number of Participants With Adverse Events Leading to Discontinuation | From first dose to date of last dose plus 30 days | The number of participants with on-study AEs leading to discontinuation was reported for each arm. |
| Number of Deaths | From first dose to date of last dose plus 30 days | The number of deaths was reported for each arm. |
| Number of Participants With Marked Laboratory Abnormalities | From first dose to date of last dose plus 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | From Day 1 to 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. |
| Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | From Day 1 to 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. |
| Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | From Day 1 to 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. |
Countries
United States
Participant flow
Pre-assignment details
184 participants enrolled; 80 entered lead-in phase; 75 were randomized and treated. Those did not enter lead-in phase: 95 no longer met study criteria; 5 withdrew consent; 1 poor/non-compliance; 3 other reasons. 2 from lead-in phase not randomized as no longer met study criteria. 3 from lead-in phase were randomized in the PK cohort (sub-study).
Participants by arm
| Arm | Count |
|---|---|
| BMS-986036 10 mg QD Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting. | 25 |
| BMS-986036 20 mg QW Participants self-administered 20 mg SC injections of BMS-986036, once weekly (QW), for 16 weeks in a double-blind, outpatient setting. The injection for days 2-7 of each treatment week was placebo to maintain the blind between daily and weekly treatment arms. | 24 |
| Placebo QD Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting. | 26 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up | Lost to Follow-up | 1 | 1 | 0 |
| Follow-up | Subject unable to return for visit | 0 | 0 | 1 |
| Follow-up | Subject Withdrew Consent | 1 | 0 | 1 |
| Treatment | Lost to Follow-up | 0 | 2 | 1 |
| Treatment | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo QD | BMS-986036 10 mg QD | BMS-986036 20 mg QW |
|---|---|---|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 11.62 | 45.5 years STANDARD_DEVIATION 11.89 | 52.2 years STANDARD_DEVIATION 9.99 | 51.5 years STANDARD_DEVIATION 12.09 |
| Age, Customized < 65 years of age | 69 Participants | 25 Participants | 23 Participants | 21 Participants |
| Age, Customized >= 65 years of age | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 7 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 19 Participants | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hepatic Fat Fraction | 19.615 Percentage STANDARD_DEVIATION 6.9272 | 21.282 Percentage STANDARD_DEVIATION 7.3312 | 17.771 Percentage STANDARD_DEVIATION 7.2119 | 19.736 Percentage STANDARD_DEVIATION 5.8524 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 72 Participants | 25 Participants | 24 Participants | 23 Participants |
| Sex: Female, Male Female | 48 Participants | 16 Participants | 15 Participants | 17 Participants |
| Sex: Female, Male Male | 27 Participants | 10 Participants | 10 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 13 / 25 | 10 / 24 | 11 / 26 |
| serious Total, serious adverse events | 1 / 25 | 0 / 24 | 1 / 26 |
Outcome results
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.
Time frame: From Day 1 to Day 112
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| BMS-986036 10 mg QD | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 57 | -8.43 percentage |
| BMS-986036 10 mg QD | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 112 | -6.77 percentage |
| BMS-986036 20 mg QW | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 57 | -6.45 percentage |
| BMS-986036 20 mg QW | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 112 | -5.20 percentage |
| Placebo QD | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 57 | -1.26 percentage |
| Placebo QD | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Day 112 | -1.35 percentage |
Comparison: Day 5790% CI: [-9.09, -5.26]
Comparison: Day 5790% CI: [-7.14, -3.25]
Comparison: Day 112p-value: 0.000490% CI: [-8.01, -2.84]t-test, 1 sided
Comparison: Day 112p-value: 0.008490% CI: [-6.47, -1.23]t-test, 1 sided
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.
Time frame: From Day 1 to Day 112
Population: All treated participants with DXA data at baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986036 10 mg QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Femoral Neck | -2.79 Percentage | Standard Deviation 4.329 |
| BMS-986036 10 mg QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Hip | -0.91 Percentage | Standard Deviation 2.422 |
| BMS-986036 10 mg QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Spine | -1.19 Percentage | Standard Deviation 2.658 |
| BMS-986036 10 mg QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Total Body Less Head | -0.43 Percentage | Standard Deviation 1.483 |
| BMS-986036 20 mg QW | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Total Body Less Head | -0.35 Percentage | Standard Deviation 1.529 |
| BMS-986036 20 mg QW | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Femoral Neck | -1.08 Percentage | Standard Deviation 2.744 |
| BMS-986036 20 mg QW | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Spine | -1.21 Percentage | Standard Deviation 2.394 |
| BMS-986036 20 mg QW | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Hip | -1.10 Percentage | Standard Deviation 1.549 |
| Placebo QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Total Body Less Head | 0.10 Percentage | Standard Deviation 1.545 |
| Placebo QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Hip | -0.93 Percentage | Standard Deviation 3.438 |
| Placebo QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Spine | -1.32 Percentage | Standard Deviation 3.203 |
| Placebo QD | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | Femoral Neck | -0.11 Percentage | Standard Deviation 2.749 |
Primary
Number of Deaths
The number of deaths was reported for each arm.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Deaths | 0 Participants |
| BMS-986036 20 mg QW | Number of Deaths | 0 Participants |
| Placebo QD | Number of Deaths | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs)
The number of participants with on-study AEs was reported for each arm.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Adverse Events (AEs) | 18 Participants |
| BMS-986036 20 mg QW | Number of Participants With Adverse Events (AEs) | 13 Participants |
| Placebo QD | Number of Participants With Adverse Events (AEs) | 15 Participants |
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.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| BMS-986036 20 mg QW | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| Placebo QD | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
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.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | PR > 200 msec | 2 Participants |
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QRS > 120 msec | 1 Participants |
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT > 500 msec | 0 Participants |
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF > 450 msec | 2 Participants |
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT change from baseline > 30 msec | 5 Participants |
| BMS-986036 10 mg QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF change from baseline > 30 msec | 6 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF change from baseline > 30 msec | 2 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | PR > 200 msec | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF > 450 msec | 2 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT change from baseline > 30 msec | 6 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | QRS > 120 msec | 0 Participants |
| BMS-986036 20 mg QW | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT > 500 msec | 0 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QRS > 120 msec | 3 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT > 500 msec | 0 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF change from baseline > 30 msec | 3 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTcF > 450 msec | 1 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | PR > 200 msec | 2 Participants |
| Placebo QD | Number of Participants With Electrocardiogram (ECG) Abnormalities | QT change from baseline > 30 msec | 5 Participants |
Primary
Number of Participants With Injection Site Reactions
The number of participants with on-study injection site reactions was reported for each arm.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Bruising | 2 Participants |
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Erythema | 1 Participants |
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Reaction | 1 Participants |
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Pain | 0 Participants |
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Rash | 0 Participants |
| BMS-986036 10 mg QD | Number of Participants With Injection Site Reactions | Injection Site Swelling | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Swelling | 0 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Bruising | 2 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Pain | 0 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Rash | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Erythema | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Injection Site Reactions | Injection Site Reaction | 1 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Erythema | 1 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Reaction | 0 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Swelling | 0 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Pain | 1 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Bruising | 0 Participants |
| Placebo QD | Number of Participants With Injection Site Reactions | Injection Site Rash | 0 Participants |
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.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Marked Laboratory Abnormalities | Alanine Aminotransferase (ALT) | 1 Participants |
| BMS-986036 10 mg QD | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting - high | 0 Participants |
| BMS-986036 20 mg QW | Number of Participants With Marked Laboratory Abnormalities | Alanine Aminotransferase (ALT) | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting - high | 1 Participants |
| Placebo QD | Number of Participants With Marked Laboratory Abnormalities | Alanine Aminotransferase (ALT) | 2 Participants |
| Placebo QD | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting - high | 0 Participants |
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.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Physical Examination Abnormalities | 11 Participants |
| BMS-986036 20 mg QW | Number of Participants With Physical Examination Abnormalities | 9 Participants |
| Placebo QD | Number of Participants With Physical Examination Abnormalities | 12 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
The number of participants with on-study SAEs was reported for each arm.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| BMS-986036 20 mg QW | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Placebo QD | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
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.
Time frame: From first dose to date of last dose plus 30 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Vital Sign Abnormalities | 17 Participants |
| BMS-986036 20 mg QW | Number of Participants With Vital Sign Abnormalities | 16 Participants |
| Placebo QD | Number of Participants With Vital Sign Abnormalities | 14 Participants |
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.
Time frame: From Day 1 to Day 112
Population: All treated participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986036 10 mg QD | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | C-Terminal Intact | 162 ng/mL | Geometric Coefficient of Variation 78.8 |
| BMS-986036 10 mg QD | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | Total | 3250 ng/mL | Geometric Coefficient of Variation 52.7 |
| BMS-986036 20 mg QW | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | C-Terminal Intact | 10.9 ng/mL | Geometric Coefficient of Variation 113 |
| BMS-986036 20 mg QW | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | Total | 1130 ng/mL | Geometric Coefficient of Variation 53.8 |
| Placebo QD | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | C-Terminal Intact | NA ng/mL | — |
| Placebo QD | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | Total | NA ng/mL | — |
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.
Time frame: From Day 1 to Day 142
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | 23 Participants |
| BMS-986036 20 mg QW | Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | 15 Participants |
| Placebo QD | Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | 0 Participants |
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.
Time frame: From Day 1 to Day 142
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986036 10 mg QD | Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | 23 Participants |
| BMS-986036 20 mg QW | Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | 15 Participants |
| Placebo QD | Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | 0 Participants |