Trial Outcomes & Findings for A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH) (NCT NCT02413372)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

184 participants

Primary outcome timeframe

From Day 1 to Day 112

Results posted on

2021-02-26

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.	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.	Placebo QD Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Treatment STARTED	25	24	26
Treatment COMPLETED	24	22	25
Treatment NOT COMPLETED	1	2	1
Follow-up STARTED	22	21	25
Follow-up COMPLETED	20	20	23
Follow-up NOT COMPLETED	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Placebo QD Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Treatment Lost to Follow-up	0	2	1
Treatment Withdrawal by Subject	1	0	0
Follow-up Lost to Follow-up	1	1	0
Follow-up Subject Withdrew Consent	1	0	1
Follow-up Subject unable to return for visit	0	0	1

Baseline Characteristics

All treated participants

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From Day 1 to Day 112

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 Day 57	-8.43 percentage Interval -9.81 to -7.06	-6.45 percentage Interval -7.9 to -5.0	-1.26 percentage Interval -2.58 to 0.06
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 Day 112	-6.77 percentage Interval -8.64 to -4.91	-5.20 percentage Interval -7.13 to -3.26	-1.35 percentage Interval -3.13 to 0.43

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with on-study AEs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Adverse Events (AEs)	18 Participants	13 Participants	15 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with on-study SAEs was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Serious Adverse Events (SAEs)	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with on-study injection site reactions was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Injection Site Reactions Injection Site Bruising	2 Participants	2 Participants	0 Participants
Number of Participants With Injection Site Reactions Injection Site Erythema	1 Participants	1 Participants	1 Participants
Number of Participants With Injection Site Reactions Injection Site Reaction	1 Participants	1 Participants	0 Participants
Number of Participants With Injection Site Reactions Injection Site Pain	0 Participants	0 Participants	1 Participants
Number of Participants With Injection Site Reactions Injection Site Rash	0 Participants	1 Participants	0 Participants
Number of Participants With Injection Site Reactions Injection Site Swelling	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with on-study AEs leading to discontinuation was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Adverse Events Leading to Discontinuation	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of deaths was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Deaths	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Marked Laboratory Abnormalities Alanine Aminotransferase (ALT)	1 Participants	1 Participants	2 Participants
Number of Participants With Marked Laboratory Abnormalities Glucose, Fasting - high	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Vital Sign Abnormalities	17 Participants	16 Participants	14 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF change from baseline > 30 msec	6 Participants	2 Participants	3 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities PR > 200 msec	2 Participants	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QRS > 120 msec	1 Participants	0 Participants	3 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QT > 500 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF > 450 msec	2 Participants	2 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QT change from baseline > 30 msec	5 Participants	6 Participants	5 Participants

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: All treated participants

The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Physical Examination Abnormalities	11 Participants	9 Participants	12 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 112

Population: All treated participants with DXA data at baseline and 6 months

The mean percent change in bone mineral density from baseline to day 112 reported for each arm.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
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	-1.08 Percentage Standard Deviation 2.744	-0.11 Percentage Standard Deviation 2.749
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) Hip	-0.91 Percentage Standard Deviation 2.422	-1.10 Percentage Standard Deviation 1.549	-0.93 Percentage Standard Deviation 3.438
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) Spine	-1.19 Percentage Standard Deviation 2.658	-1.21 Percentage Standard Deviation 2.394	-1.32 Percentage Standard Deviation 3.203
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	-0.35 Percentage Standard Deviation 1.529	0.10 Percentage Standard Deviation 1.545

SECONDARY outcome

Timeframe: From Day 1 to Day 112

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=20 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=21 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 Total	3250 ng/mL Geometric Coefficient of Variation 52.7	1130 ng/mL Geometric Coefficient of Variation 53.8	NA ng/mL Geometric Coefficient of Variation NA Only reported for drug intervention arms.
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	10.9 ng/mL Geometric Coefficient of Variation 113	NA ng/mL Geometric Coefficient of Variation NA Only reported for drug intervention arms.

SECONDARY outcome

Timeframe: From Day 1 to Day 142

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142	23 Participants	15 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 142

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142	23 Participants	15 Participants	0 Participants

Adverse Events

BMS-986036 10 mg QD

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

BMS-986036 20 mg QW

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo QD

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BMS-986036 10 mg QD n=25 participants at risk Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 participants at risk 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.	Placebo QD n=26 participants at risk Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Infections and infestations Cellulitis	0.00% 0/25 • 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).	0.00% 0/24 • 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).	3.8% 1/26 • 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).
Psychiatric disorders Depression	4.0% 1/25 • 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).	0.00% 0/24 • 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).	0.00% 0/26 • 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).
Psychiatric disorders Suicide attempt	4.0% 1/25 • 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).	0.00% 0/24 • 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).	0.00% 0/26 • 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).

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	BMS-986036 10 mg QD n=25 Participants Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 Participants 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.	Placebo QD n=26 Participants Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.	Total n=75 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 9.99 • n=5 Participants • All treated participants	51.5 years STANDARD_DEVIATION 12.09 • n=7 Participants • All treated participants	45.5 years STANDARD_DEVIATION 11.89 • n=5 Participants • All treated participants	49.7 years STANDARD_DEVIATION 11.62 • n=4 Participants • All treated participants
Age, Customized < 65 years of age	23 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants	69 Participants n=4 Participants
Age, Customized >= 65 years of age	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants • All treated participants	17 Participants n=7 Participants • All treated participants	16 Participants n=5 Participants • All treated participants	48 Participants n=4 Participants • All treated participants
Sex: Female, Male Male	10 Participants n=5 Participants • All treated participants	7 Participants n=7 Participants • All treated participants	10 Participants n=5 Participants • All treated participants	27 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants • All treated participants	6 Participants n=7 Participants • All treated participants	7 Participants n=5 Participants • All treated participants	20 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants • All treated participants	18 Participants n=7 Participants • All treated participants	19 Participants n=5 Participants • All treated participants	55 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants • All treated participants	1 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	1 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	1 Participants n=5 Participants • All treated participants	2 Participants n=4 Participants • All treated participants
Race (NIH/OMB) White	24 Participants n=5 Participants • All treated participants	23 Participants n=7 Participants • All treated participants	25 Participants n=5 Participants • All treated participants	72 Participants n=4 Participants • All treated participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Hepatic Fat Fraction	17.771 Percentage STANDARD_DEVIATION 7.2119 • n=5 Participants • All treated participants	19.736 Percentage STANDARD_DEVIATION 5.8524 • n=7 Participants • All treated participants	21.282 Percentage STANDARD_DEVIATION 7.3312 • n=5 Participants • All treated participants	19.615 Percentage STANDARD_DEVIATION 6.9272 • n=4 Participants • All treated participants

Measure	BMS-986036 10 mg QD n=25 participants at risk Participants self-administered 10 mg subcutaneous (SC) injections of BMS-986036, once daily (QD), for 16 weeks in a double-blind, outpatient setting.	BMS-986036 20 mg QW n=24 participants at risk 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.	Placebo QD n=26 participants at risk Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
Gastrointestinal disorders Constipation	4.0% 1/25 • 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).	0.00% 0/24 • 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).	7.7% 2/26 • 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).
Gastrointestinal disorders Diarrhoea	12.0% 3/25 • 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).	20.8% 5/24 • 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).	7.7% 2/26 • 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).
Gastrointestinal disorders Frequent bowel movements	20.0% 5/25 • 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).	0.00% 0/24 • 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).	0.00% 0/26 • 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).
Gastrointestinal disorders Nausea	16.0% 4/25 • 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).	12.5% 3/24 • 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).	7.7% 2/26 • 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).
General disorders Fatigue	4.0% 1/25 • 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).	0.00% 0/24 • 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).	19.2% 5/26 • 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).
General disorders Injection site bruising	8.0% 2/25 • 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).	8.3% 2/24 • 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).	0.00% 0/26 • 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).
General disorders Oedema peripheral	0.00% 0/25 • 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).	8.3% 2/24 • 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).	0.00% 0/26 • 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).
Infections and infestations Influenza	0.00% 0/25 • 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).	0.00% 0/24 • 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).	7.7% 2/26 • 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).
Infections and infestations Urinary tract infection	4.0% 1/25 • 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).	12.5% 3/24 • 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).	7.7% 2/26 • 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).
Metabolism and nutrition disorders Increased appetite	0.00% 0/25 • 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).	12.5% 3/24 • 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).	0.00% 0/26 • 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).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/25 • 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).	0.00% 0/24 • 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).	11.5% 3/26 • 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).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • 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).	8.3% 2/24 • 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).	3.8% 1/26 • 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).
Nervous system disorders Headache	4.0% 1/25 • 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).	8.3% 2/24 • 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).	11.5% 3/26 • 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).
Renal and urinary disorders Glycosuria	8.0% 2/25 • 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).	0.00% 0/24 • 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).	0.00% 0/26 • 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).
Respiratory, thoracic and mediastinal disorders Cough	4.0% 1/25 • 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).	4.2% 1/24 • 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).	7.7% 2/26 • 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).