Safety, Tolerability, Pharmacokinetics and Efficacy of LM... | NCT02913105

Label	Type	Description	Intervention Names
LMB763	Experimental	Oral dose once daily for 12 weeks (84 days)	Drug: LMB763
Placebo	Placebo Comparator	Oral dose once daily for 12 weeks (84 days)	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LMB763	Drug	Hard Gelatin Capsules	LMB763
Placebo

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. No statistical analysis was planned for this primary outcome measure.	From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))
Change From Baseline in Alanine Aminotransferase (ALT) Levels	ALT level assessment is one of the diagnostic parameters in Liver function test (LFT). Baseline was defined as the mean of ALT levels at baseline and pre-dose visits. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).	Baseline to Day 84 (Week 12)

Measure	Description	Time Frame
Observed Maximum Plasma Concentration (Cmax) of LMB763	No statistical analysis was planned for this outcome measure.	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
Time to Reach Maximum Concentration (Tmax) of LMB763

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Culver City	California	90230	United States
Novartis Investigative Site

Label	URL
A Plain Language Trial Summary is available on novartisclinicatrials.com	View source

ID	Title	Description
FG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
FG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 2, 2017	Sep 19, 2019

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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. No statistical analysis was planned for this primary outcome measure.

Safety analysis set included all participants that received at least one dose of study drug.

Posted

Count of Participants

Participants

From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units	Counts
Participants	OG00037 OG00144 OG00240

Title

Denominators

Categories

AEs

Title	Measurements
	OG00035 OG00137 OG00233

SAEs

Primary

Change From Baseline in Alanine Aminotransferase (ALT) Levels

ALT level assessment is one of the diagnostic parameters in Liver function test (LFT). Baseline was defined as the mean of ALT levels at baseline and pre-dose visits. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

units per liter (U/L)

Baseline to Day 84 (Week 12)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Observed Maximum Plasma Concentration (Cmax) of LMB763

No statistical analysis was planned for this outcome measure.

Pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. Number analyzed is the number of participants with data available for analysis at specified time-point.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units	Counts
Participants

Secondary

Time to Reach Maximum Concentration (Tmax) of LMB763

No statistical analysis was planned for this outcome measure.

PK analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. Number analyzed is the number of participants with data available for analysis at specified time-point.

Posted

Median

Full Range

hour (h)

0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units	Counts
Participants	OG000

Secondary

Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763

No statistical analysis was planned for this outcome measure.

Posted

Mean

Standard Deviation

h*ng/mL

0 to 96 hours post-dose on Days 1 and 42

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units	Counts
Participants

Secondary

Accumulation Ratio (Racc) of LMB763

The drug accumulation ratio (Racc) is the ratio of accumulation of drug going from a single dose to steady state with repeated administration.

No statistical analysis was planned for this outcome measure.

Posted

Mean

Standard Deviation

ratio

Day 42

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)

Participants were to undergo MRI twice (Baseline and End of Treatment) during the course of the study to quantitate liver fat. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage of liver fat

Baseline to Day 84 (Week 12)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Change From Baseline in Weight

Baseline was defined as the last available measurement prior to the first dose.

Posted

Mean

Standard Deviation

kilogram (kg)

Baseline to Days 28, 42, 56, 84 and 112 (EOS)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units

Secondary

Change From Baseline in Body Mass Index (BMI)

Baseline was defined as the last available measurement prior to the first dose at specified visit (day).

Posted

Mean

Standard Deviation

kilograms per meter square (kg/m^2)

Baseline to Days 28, 42, 56, 84 and 112 (EOS)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo was self-administered orally once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Change From Baseline in Waist to Hip Ratio

Baseline was defined as the last available measurement prior to the first dose.

Posted

Mean

Standard Deviation

ratio

Baseline to Days 28, 42, 56, 84 and 112 (EOS)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Units

Secondary

Change From to Baseline in Liver Stiffness

Fibroscan® was performed where available to assess liver stiffness. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

Posted

Geometric Mean

Geometric Coefficient of Variation

kilopascal (kPa)

Baseline to Day 84 (Week 12)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel

The ADVIA CentaurR systems' ELF™ test is an in vitro diagnostic multivariate index assay that provides a single score by combining quantitative measurements of hyaluronic acid (HA), amino-terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) in human serum using the ADVIA Centaur XP, ADVIA Centaur XPT, and ADVIA Centaur CP systems in an algorithm. ELF score for the ADVIA Centaur systems is calculated by, first obtaining results for the ADVIA Centaur HA, PIIINP, and TIMP-1 assays and then using the following equation/algorithm:

ADVIA Centaur XP/XPT:

ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln(CP3NP) + 0.394 ln(CTIMP1)

ADVIA Centaur CP:

ELF score = 2.494 + 0.846 ln(CHA) + 0.735 ln(CP3NP) + 0.391 ln(CTIMP1) Concentrations (C) of each assay are in ng/mL

Interpretation of ELF score is as follows:

< 7.7 None to mild

7.7 to < 9.8 Moderate
9.8 Severe

Posted

Geometric Mean

Geometric Coefficient of Variation

ELF score

Baseline to Days 42 and 84

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg

Secondary

Change From Baseline in Fibrosis Biomarker Test

Fibrosis Biomarker test included hyaluronic acid (HA), amino-terminal pro-peptide of procollagen type III (PIIINP), and tissue inhibitor of metalloproteinases (TIMP-1) as markers of liver fibrosis. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed in the number of participants with all observations non-missing, including censored data.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per liter (ug/L)

Baseline to Days 42 and 84

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo

Secondary

Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)

Lipid measurements were collected under fasted conditions. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

Posted

Geometric Mean

Geometric Coefficient of Variation

milligrams per deciliter (mg/dL)

Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol

Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).

Posted

Geometric Mean

Geometric Coefficient of Variation

millimole per liter (mmol/L)

Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Secondary

Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin

A 10 cm VAS was used to assess the severity of participants itch (ranging from 0 = no itch at all to 10 = the worst imaginable itch). The score (distance from left) on the VAS was recorded by the participant marking with a line and used to test for an effect of LMB763 over placebo. Baseline was defined as the last available measurement prior to the first dose. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Day 84 (Week 12)

ID	Title	Description
OG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
OG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected44 at risk EG0022 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected44 at risk EG0023 affected40 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0012 affected44 at risk EG0023 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0014 affected44 at risk EG0024 affected40 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0023 affected40 at risk
Faeces pale	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0007 affected37 at risk EG0015 affected44 at risk EG0022 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0013 affected44 at risk EG0020 affected40 at risk
Fatigue	General disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0012 affected44 at risk EG0024 affected40 at risk
Influenza like illness	General disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected44 at risk EG0024 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0012 affected44 at risk EG0023 affected40 at risk
Oral herpes	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0012 affected44 at risk EG0020 affected40 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0014 affected44 at risk EG0022 affected40 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected44 at risk EG0023 affected40 at risk
Viral infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0014 affected44 at risk EG0021 affected40 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected44 at risk EG0022 affected40 at risk
Alanine aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0012 affected44 at risk EG0024 affected40 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0011 affected44 at risk EG0021 affected40 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0011 affected44 at risk EG0020 affected40 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected44 at risk EG0023 affected40 at risk
Blood creatinine increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0011 affected44 at risk EG0020 affected40 at risk
Blood glucose increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected44 at risk EG0022 affected40 at risk
Eosinophil count increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected44 at risk EG0022 affected40 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected44 at risk EG0022 affected40 at risk
Lymphocyte count decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Lymphocyte count increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0022 affected40 at risk
Neutrophil count decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0011 affected44 at risk EG0024 affected40 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0014 affected44 at risk EG0025 affected40 at risk
Urine protein/creatinine ratio increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0007 affected37 at risk EG0018 affected44 at risk EG0023 affected40 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0014 affected44 at risk EG0020 affected40 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0013 affected44 at risk EG0020 affected40 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0013 affected44 at risk EG0021 affected40 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected44 at risk EG0023 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected44 at risk EG0023 affected40 at risk
Dizziness	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0013 affected44 at risk EG0021 affected40 at risk
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0017 affected44 at risk EG0028 affected40 at risk
Paraesthesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0013 affected44 at risk EG0020 affected40 at risk
Anxiety	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected44 at risk EG0023 affected40 at risk
Insomnia	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0012 affected44 at risk EG0020 affected40 at risk
Renal disorder	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0014 affected44 at risk EG0021 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected37 at risk EG0012 affected44 at risk EG0022 affected40 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00020 affected37 at risk EG00113 affected44 at risk EG0026 affected40 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0004 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	HDL Cholesterol: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	0.0005	Geometric Mean Ratios	0.91	2-Sided	90	0.87	0.95	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.0005	Geometric Mean Ratios	0.89	2-Sided	90	0.84	0.94	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	0.0062	Geometric Mean Ratios	0.91	2-Sided	90	0.86	0.96	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.1214	Geometric Mean Ratios	0.94	2-Sided	90	0.89	1.00	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	0.0043	Geometric Mean Ratios	0.90	2-Sided	90	0.84	0.95	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.2615	Geometric Mean Ratios	0.95	2-Sided	90	0.89	1.02	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	HDL Cholesterol: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.1331	Geometric Mean Ratios	0.94	2-Sided	90	0.88	1.01	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	<.0001	Geometric Mean Ratios	0.85	2-Sided	90	0.81	0.89	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.0001	Geometric Mean Ratios	0.88	2-Sided	90	0.83	0.93	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	<.0001	Geometric Mean Ratios	0.83	2-Sided	90	0.79	0.88	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.0002	Geometric Mean Ratios	0.86	2-Sided	90	0.81	0.92	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	<.0001	Geometric Mean Ratios	0.82	2-Sided	90	0.77	0.88	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.0002	Geometric Mean Ratios	0.84	2-Sided	90	0.78	0.90	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	HDL Cholesterol: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.2280	Geometric Mean Ratios	0.95	2-Sided	90	0.89	1.02	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	0.0090	Geometric Mean Ratios	0.93	2-Sided	90	0.89	0.97	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.6237	Geometric Mean Ratios	0.98	2-Sided	90	0.93	1.04	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	0.0080	Geometric Mean Ratios	0.91	2-Sided	90	0.87	0.97	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.0105	Geometric Mean Ratios	0.91	2-Sided	90	0.86	0.97	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	0.0217	Geometric Mean Ratios	0.92	2-Sided	90	0.86	0.98	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.0031	Geometric Mean Ratios	0.88	2-Sided	90	0.82	0.94	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	HDL Cholesterol: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.7740	Geometric Mean Ratios	1.01	2-Sided	90	0.95	1.07	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	0.1783	Geometric Mean Ratios	0.95	2-Sided	90	0.89	1.01	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.0219	Geometric Mean Ratios	0.91	2-Sided	90	0.84	0.97	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	0.0719	Geometric Mean Ratios	0.92	2-Sided	90	0.85	0.99	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.2199	Geometric Mean Ratios	0.93	2-Sided	90	0.85	1.02	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	0.4928	Geometric Mean Ratios	0.96	2-Sided	90	0.87	1.06	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.3419	Geometric Mean Ratios	0.94	2-Sided	90	0.85	1.05	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG001	LDL Cholesterol Friedwald: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.7281	Geometric Mean Ratios	0.98	2-Sided	90	0.88	1.09	Other	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	0.3180	Geometric Mean Ratios	1.04	2-Sided	90	0.97	1.12	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.6576	Geometric Mean Ratios	1.02	2-Sided	90	0.95	1.10	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	0.6035	Geometric Mean Ratios	0.97	2-Sided	90	0.90	1.06	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.3261	Geometric Mean Ratios	1.06	2-Sided	90	0.96	1.17	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	0.5246	Geometric Mean Ratios	1.04	2-Sided	90	0.94	1.15	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.7519	Geometric Mean Ratios	1.02	2-Sided	90	0.92	1.14	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG000 OG002	LDL Cholesterol Friedwald: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.9577	Geometric Mean Ratios	1.00	2-Sided	90	0.89	1.12	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 7	ANCOVA	An unstructured variance-covariance structure was used.	0.0160	Geometric Mean Ratios	1.10	2-Sided	90	1.03	1.18	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 14	ANCOVA	An unstructured variance-covariance structure was used.	0.0052	Geometric Mean Ratios	1.13	2-Sided	90	1.05	1.21	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 28	ANCOVA	An unstructured variance-covariance structure was used.	0.1822	Geometric Mean Ratios	1.06	2-Sided	90	0.99	1.15	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 42	ANCOVA	An unstructured variance-covariance structure was used.	0.0159	Geometric Mean Ratios	1.14	2-Sided	90	1.04	1.24	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 56	ANCOVA	An unstructured variance-covariance structure was used.	0.1524	Geometric Mean Ratios	1.08	2-Sided	90	0.99	1.19	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 84	ANCOVA	An unstructured variance-covariance structure was used.	0.1749	Geometric Mean Ratios	1.08	2-Sided	90	0.98	1.20	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
OG001 OG002	LDL Cholesterol Friedwald: Day 112 (EOS)	ANCOVA	An unstructured variance-covariance structure was used.	0.7503	Geometric Mean Ratios	1.02	2-Sided	90	0.92	1.13	Superiority	Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).

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

ID	Title	Description
BG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
BG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
BG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LMB763 100 mg	LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).	37	2	37	35	37
EG001	LMB763 50 mg	LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).	44	3	44	37	44
EG002	Pooled Placebo	LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).	40	0	40	33	40

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected44 at risk EG0020 affected40 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Otitis media	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected44 at risk EG0020 affected40 at risk
Benign small intestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected44 at risk EG0020 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected44 at risk EG0020 affected40 at risk