A Study of BMS-986036 in Subjects With Non-Alcoholic Stea... | NCT02413372

NCT02413372

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group A: BMS-986036	Experimental	Administered as specified on specified days	Drug: BMS-986036
Treatment Group B: BMS-986036	Experimental	Administered as specified on specified days	Drug: BMS-986036
Treatment Group C: Placebo	Placebo Comparator	Administered as specified on specified days	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BMS-986036	Drug		Treatment Group A: BMS-986036
BMS-986036

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Inland Empire Liver Foundation		Rialto	California	92377	United States
University Of California, San Diego

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30554783	Derived	Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R. Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.

Label	URL
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	BMS-986036 20 mg QW

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

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

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

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.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

All treated participants

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.2± 9.99 BG00151.5± 12.09 BG00245.5± 11.89 BG003

Age, Customized

Age categorization

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 years of age	BG00023 BG00121 BG002

Sex: Female, Male

All treated participants

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00015 BG00117 BG002

Ethnicity (NIH/OMB)

All treated participants

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0016 BG002

Race (NIH/OMB)

All treated participants

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Hepatic Fat Fraction

All treated participants

Mean

Standard Deviation

Percentage

Title

Denominators

Categories

Title	Measurements
	BG00017.771± 7.2119 BG00119.736± 5.8524 BG002

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

Posted

Mean

90% Confidence Interval

percentage

From Day 1 to Day 112

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts
Participants	OG00025 OG00124 OG00226

Title

Denominators

Categories

Day 57

- ParticipantsOG00024
- ParticipantsOG00121
- ParticipantsOG00224

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Day 57					Mean Difference (Final Values)	-7.17			2-Sided	90	-9.09	-5.26			mean difference in adjusted change from baseline vs placebo		Superiority
OG001 OG002	Day 57

Primary

Number of Participants With Adverse Events (AEs)

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

All treated participants

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts

Primary

Number of Deaths

The number of deaths was reported for each arm.

All treated participants

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units	Counts
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.

All treated participants

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

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

Posted

Number

Participants

From first dose to date of last dose plus 30 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Units

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

Posted

Mean

Standard Deviation

Percentage

From Day 1 to Day 112

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

From Day 1 to Day 112

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

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

Posted

Number

Participants

From Day 1 to Day 142

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

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

Posted

Number

Participants

From Day 1 to Day 142

ID	Title	Description
OG000	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.
OG001	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.
OG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	1	25	13	25
EG001	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	0	24	10	24
EG002	Placebo QD	Participants self-administered SC injections of placebo, once daily, for 16 weeks in a double-blind, outpatient setting.	26	1	26	11	26

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0021 affected26 at risk
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected26 at risk
Suicide attempt	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected26 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0022 affected26 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected25 at risk EG0015 affected24 at risk EG0022 affected26 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected25 at risk EG0010 affected24 at risk EG0020 affected26 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected25 at risk EG0013 affected24 at risk EG0022 affected26 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0025 affected26 at risk
Injection site bruising	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected25 at risk EG0012 affected24 at risk EG0020 affected26 at risk
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0012 affected24 at risk EG0020 affected26 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0022 affected26 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0013 affected24 at risk EG0022 affected26 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0013 affected24 at risk EG0020 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0023 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected25 at risk EG0012 affected24 at risk EG0021 affected26 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0012 affected24 at risk EG0023 affected26 at risk
Glycosuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected25 at risk EG0010 affected24 at risk EG0020 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0022 affected26 at risk

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

ID	Term
C000630067	Pegbelfermin

BG00319.615± 6.9272

OG000-8.43(-9.81 to -7.06)

OG001-6.45(-7.90 to -5.00)

OG002-1.26(-2.58 to 0.06)

Units	Counts
Participants	OG00020 OG00121 OG00226

Units	Counts
Participants	OG00025 OG00124 OG00226

Units	Counts
Participants	OG00025 OG00124 OG00226

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases