Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

A Randomized, Patient and Investigator Blinded, Placebo Controlled, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With Non-alcoholic Steatohepatitis (NASH)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02913105

Enrollment

122

Registered

2016-09-23

Start date

2016-10-24

Completion date

2018-09-19

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Steatohepatitis NASH

Keywords

Non-alcoholic Steatohepatitis, NASH, Fatty liver disease

Brief summary

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Interventions

DRUGLMB763

Hard Gelatin Capsules

DRUGPlacebo

Hard Gelatin Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male/female patients, 18 years or older * Written informed consent * Presence of NASH by histologic evidence (liver biopsy) and elevated alanine aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus

Exclusion criteria

* Current use of obeticholic acid (OCA) * New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide, albiglutide or dulaglutide within 3 months of screening * Pregnant or nursing (lactating) women * Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication * Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening * Clinical evidence of hepatic decompensation or severe liver impairment * Previous diagnosis of other forms of chronic liver disease * Uncontrolled diabetes mellitus * History or current diagnosis of ECG abnormalities * Patients with contraindications to MRI imaging

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))	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.
Change From Baseline in Alanine Aminotransferase (ALT) Levels	Baseline to Day 84 (Week 12)	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).

Secondary

Measure	Time frame	Description
Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763	0 to 96 hours post-dose on Days 1 and 42	No statistical analysis was planned for this outcome measure.
Accumulation Ratio (Racc) of LMB763	Day 42	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.
Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Baseline to Day 84 (Week 12)	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).
Change From Baseline in Weight	Baseline to Days 28, 42, 56, 84 and 112 (EOS)	Baseline was defined as the last available measurement prior to the first dose.
Change From Baseline in Body Mass Index (BMI)	Baseline to Days 28, 42, 56, 84 and 112 (EOS)	Baseline was defined as the last available measurement prior to the first dose at specified visit (day).
Change From Baseline in Waist to Hip Ratio	Baseline to Days 28, 42, 56, 84 and 112 (EOS)	Baseline was defined as the last available measurement prior to the first dose.
Observed Maximum Plasma Concentration (Cmax) of LMB763	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42	No statistical analysis was planned for this outcome measure.
Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline to Days 42 and 84	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
Change From Baseline in Fibrosis Biomarker Test	Baseline to Days 42 and 84	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).
Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)	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).
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)	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).
Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Baseline to Day 84 (Week 12)	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.
Change From to Baseline in Liver Stiffness	Baseline to Day 84 (Week 12)	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).
Time to Reach Maximum Concentration (Tmax) of LMB763	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42	No statistical analysis was planned for this outcome measure.

Countries

Australia, Georgia, Jordan, New Zealand, Puerto Rico, Switzerland, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted in 25 centers across 6 countries.

Pre-assignment details

A total of 121 participants were enrolled in the study, and included in the safety population. Placebo data have been pooled from placebo treated participants from both cohorts (100 mg and 50 mg matching placebo).

Participants by arm

Arm	Count
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
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
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
Total	121

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	11	0	4
Overall Study	Non-Compliance With Study Drug	0	0	1
Overall Study	Physician Decision	1	1	0
Overall Study	Reason Not Specified	3	1	1
Overall Study	Withdrawal by Subject	0	3	1

Baseline characteristics

Characteristic	Total	LMB763 100 mg	LMB763 50 mg	Pooled Placebo
Age, Continuous	50.8 years STANDARD_DEVIATION 11.96	51.3 years STANDARD_DEVIATION 15.55	49.5 years STANDARD_DEVIATION 8.45	51.6 years STANDARD_DEVIATION 11.65
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants	9 Participants	11 Participants	10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants	27 Participants	33 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Asian	9 Participants	2 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Black Or African American	3 Participants	1 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Multiple	5 Participants	1 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	2 Participants	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Other	2 Participants	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	100 Participants	32 Participants	37 Participants	31 Participants
Sex: Female, Male Female	69 Participants	22 Participants	23 Participants	24 Participants
Sex: Female, Male Male	52 Participants	15 Participants	21 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 37	0 / 44	0 / 40
other Total, other adverse events	35 / 37	37 / 44	33 / 40
serious Total, serious adverse events	2 / 37	3 / 44	0 / 40

Outcome results

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).

Time frame: Baseline to Day 84 (Week 12)

Population: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Baseline for Day 84 Analysis	67.215 units per liter (U/L)	Geometric Coefficient of Variation 30.8
LMB763 100 mg	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Change from Baseline at Day 84	0.667 units per liter (U/L)	Geometric Coefficient of Variation 33.8
LMB763 50 mg	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Baseline for Day 84 Analysis	48.114 units per liter (U/L)	Geometric Coefficient of Variation 42.2
LMB763 50 mg	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Change from Baseline at Day 84	0.702 units per liter (U/L)	Geometric Coefficient of Variation 41.1
Pooled Placebo	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Change from Baseline at Day 84	0.901 units per liter (U/L)	Geometric Coefficient of Variation 25.5
Pooled Placebo	Change From Baseline in Alanine Aminotransferase (ALT) Levels	Baseline for Day 84 Analysis	59.544 units per liter (U/L)	Geometric Coefficient of Variation 39.5

p-value: 0.748990% CI: [0.83, 1.13]ANCOVA

p-value: 0.000590% CI: [0.62, 0.84]ANCOVA

p-value: 0.000590% CI: [0.65, 0.85]ANCOVA

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.

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
LMB763 100 mg	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	35 Participants
LMB763 100 mg	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	2 Participants
LMB763 50 mg	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	37 Participants
LMB763 50 mg	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	3 Participants
Pooled Placebo	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	33 Participants
Pooled Placebo	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 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.

Time frame: Day 42

Arm	Measure	Value (MEAN)	Dispersion
LMB763 100 mg	Accumulation Ratio (Racc) of LMB763	0.903 ratio	Standard Deviation 0.472
LMB763 50 mg	Accumulation Ratio (Racc) of LMB763	1.31 ratio	Standard Deviation 0.641

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.

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763	Day 1	11200 h*ng/mL	Standard Deviation 4740
LMB763 100 mg	Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763	Day 42	8570 h*ng/mL	Standard Deviation 4120
LMB763 50 mg	Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763	Day 1	4360 h*ng/mL	Standard Deviation 2350
LMB763 50 mg	Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763	Day 42	5180 h*ng/mL	Standard Deviation 2870

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).

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 28 Analysis	34.81 kilograms per meter square (kg/m^2)	Standard Deviation 5.641
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 28	-0.29 kilograms per meter square (kg/m^2)	Standard Deviation 0.545
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 42 Analysis	34.05 kilograms per meter square (kg/m^2)	Standard Deviation 5.162
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 42	-0.36 kilograms per meter square (kg/m^2)	Standard Deviation 0.591
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 56 Analysis	34.12 kilograms per meter square (kg/m^2)	Standard Deviation 5.253
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 56	-0.50 kilograms per meter square (kg/m^2)	Standard Deviation 0.688
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 84 Analysis	34.18 kilograms per meter square (kg/m^2)	Standard Deviation 5.467
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 84	-0.52 kilograms per meter square (kg/m^2)	Standard Deviation 0.764
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 112 (EOS) Analysis	34.60 kilograms per meter square (kg/m^2)	Standard Deviation 5.522
LMB763 100 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 112 (EOS)	-0.45 kilograms per meter square (kg/m^2)	Standard Deviation 0.974
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 112 (EOS) Analysis	33.82 kilograms per meter square (kg/m^2)	Standard Deviation 4.98
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 28 Analysis	34.41 kilograms per meter square (kg/m^2)	Standard Deviation 5.27
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 56	-0.49 kilograms per meter square (kg/m^2)	Standard Deviation 0.799
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 56 Analysis	34.37 kilograms per meter square (kg/m^2)	Standard Deviation 5.327
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 28	-0.26 kilograms per meter square (kg/m^2)	Standard Deviation 0.638
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 112 (EOS)	-0.60 kilograms per meter square (kg/m^2)	Standard Deviation 1.276
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 84	-0.72 kilograms per meter square (kg/m^2)	Standard Deviation 1.215
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 42 Analysis	34.41 kilograms per meter square (kg/m^2)	Standard Deviation 5.27
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 84 Analysis	34.04 kilograms per meter square (kg/m^2)	Standard Deviation 5.19
LMB763 50 mg	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 42	-0.40 kilograms per meter square (kg/m^2)	Standard Deviation 0.845
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 84	-0.09 kilograms per meter square (kg/m^2)	Standard Deviation 0.718
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 42	-0.08 kilograms per meter square (kg/m^2)	Standard Deviation 0.572
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 56 Analysis	34.75 kilograms per meter square (kg/m^2)	Standard Deviation 5.269
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 56	-0.10 kilograms per meter square (kg/m^2)	Standard Deviation 0.663
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 112 (EOS) Analysis	34.96 kilograms per meter square (kg/m^2)	Standard Deviation 5.342
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 84 Analysis	34.89 kilograms per meter square (kg/m^2)	Standard Deviation 5.275
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 28 Analysis	34.93 kilograms per meter square (kg/m^2)	Standard Deviation 5.18
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 112 (EOS)	0.12 kilograms per meter square (kg/m^2)	Standard Deviation 0.776
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Change from Baseline at Day 28	-0.05 kilograms per meter square (kg/m^2)	Standard Deviation 0.511
Pooled Placebo	Change From Baseline in Body Mass Index (BMI)	Baseline for Day 42 Analysis	34.56 kilograms per meter square (kg/m^2)	Standard Deviation 5.233

Comparison: Day 28p-value: 0.812790% CI: [-0.26, 0.195]ANCOVA

Comparison: Day 42p-value: 0.890190% CI: [-0.298, 0.252]ANCOVA

Comparison: Day 56p-value: 0.620990% CI: [-0.381, 0.205]ANCOVA

Comparison: Day 84p-value: 0.839890% CI: [-0.444, 0.347]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.783990% CI: [-0.515, 0.369]ANCOVA

Comparison: Day 28p-value: 0.091190% CI: [-0.476, -0.006]ANCOVA

Comparison: Day 42p-value: 0.05290% CI: [-0.623, -0.053]ANCOVA

Comparison: Day 56p-value: 0.008590% CI: [-0.793, -0.187]ANCOVA

Comparison: Day 84p-value: 0.009190% CI: [-1.067, -0.247]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.00790% CI: [-1.216, -0.302]ANCOVA

Comparison: Day 28p-value: 0.109290% CI: [-0.423, 0.006]ANCOVA

Comparison: Day 42p-value: 0.045790% CI: [-0.574, -0.056]ANCOVA

Comparison: Day 56p-value: 0.016290% CI: [-0.676, -0.129]ANCOVA

Comparison: Day 84p-value: 0.00790% CI: [-0.975, -0.242]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.00690% CI: [-1.091, -0.281]ANCOVA

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

Time frame: Baseline to Days 42 and 84

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 42 Analysis	9.063 ELF score	Geometric Coefficient of Variation 7.3
LMB763 100 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 42	1.005 ELF score	Geometric Coefficient of Variation 5.5
LMB763 100 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 84 Analysis	9.051 ELF score	Geometric Coefficient of Variation 7.7
LMB763 100 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 84	1.005 ELF score	Geometric Coefficient of Variation 5.9
LMB763 50 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 84	1.030 ELF score	Geometric Coefficient of Variation 6.2
LMB763 50 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 42 Analysis	8.731 ELF score	Geometric Coefficient of Variation 8.2
LMB763 50 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 84 Analysis	8.739 ELF score	Geometric Coefficient of Variation 8.4
LMB763 50 mg	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 42	1.016 ELF score	Geometric Coefficient of Variation 5.8
Pooled Placebo	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 84	1.007 ELF score	Geometric Coefficient of Variation 6.3
Pooled Placebo	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Change from Baseline at Day 42	1.009 ELF score	Geometric Coefficient of Variation 7.5
Pooled Placebo	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 84 Analysis	9.220 ELF score	Geometric Coefficient of Variation 7.8
Pooled Placebo	Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel	Baseline for Day 42 Analysis	9.212 ELF score	Geometric Coefficient of Variation 8

Comparison: Day 42p-value: 0.945390% CI: [0.97, 1.02]ANCOVA

Comparison: Day 84p-value: 0.434490% CI: [0.96, 1.01]ANCOVA

Comparison: Day 42p-value: 0.63990% CI: [0.97, 1.02]ANCOVA

Comparison: Day 84p-value: 0.632990% CI: [0.97, 1.02]ANCOVA

Comparison: Day 42p-value: 0.66490% CI: [0.97, 1.02]ANCOVA

Comparison: Day 84p-value: 0.751790% CI: [0.98, 1.03]ANCOVA

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).

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 112 (EOS)	0.931 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 38.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 28	0.968 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 36.4
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 84 Analysis	188.88 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 7 Analysis	184.85 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 23
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 28 Analysis	166.54 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 45
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 84	0.958 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 17.9
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 28 Analysis	188.09 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 23.2
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 14	0.864 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 36.2
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 112 (EOS) Analysis	187.34 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 112 (EOS) Analysis	172.80 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 46.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 14 Analysis	178.22 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 50.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 112 (EOS)	0.989 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 13.6
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 84 Analysis	163.71 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 48.6
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 7	0.876 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 38.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 7 Analysis	185.66 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 55
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 28	0.952 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 15.2
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 14 Analysis	186.57 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 23.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 56	0.932 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 34.2
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 42 Analysis	206.50 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 18.3
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 7	0.957 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 14.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 56 Analysis	167.66 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 47.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 42	0.943 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 17.2
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 84	0.863 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 43.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 42	0.868 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 34.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 56 Analysis	192.25 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 14	0.963 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 17
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 42 Analysis	181.97 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 44.6
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 56	0.963 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 17.2
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 84 Analysis	201.96 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 49.5
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 7 Analysis	183.30 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 7	1.001 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 9
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 14 Analysis	183.30 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 14	1.037 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 11.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 28 Analysis	183.50 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.3
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 28	1.025 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 14.6
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 42 Analysis	182.59 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.3
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 42	1.001 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 15.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 56 Analysis	182.39 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.5
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 56	1.033 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 16.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 84 Analysis	181.63 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 84	1.037 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 18.9
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 112 (EOS) Analysis	181.47 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 112 (EOS)	1.039 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 16.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 7 Analysis	198.88 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 47.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 7	0.854 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 25.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 14 Analysis	198.88 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 47.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 14	0.881 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 28.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 28 Analysis	201.00 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 47.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 28	0.937 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 37
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 42 Analysis	203.65 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 47.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 42	0.872 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 36.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 56 Analysis	202.64 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 48.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 56	0.948 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 38.9
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 84	0.956 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 45.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 112 (EOS) Analysis	203.55 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 49.2
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 112 (EOS)	1.003 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 39.9
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 28 Analysis	177.66 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 60.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 56	1.002 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 15.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 7 Analysis	188.97 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 28	0.971 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 33.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 56 Analysis	190.33 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 21
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 84	0.947 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 33.3
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 42 Analysis	174.48 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 64.4
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 42	0.940 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 14.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 7	1.002 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 10.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 42	0.920 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 35.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 42 Analysis	191.65 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 21.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 112 (EOS)	1.039 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 39
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 56 Analysis	174.78 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 60.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 28	1.007 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 12.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 112 (EOS) Analysis	179.36 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 62.5
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 56	0.965 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 28.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 7 Analysis	175.18 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 58.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 112 (EOS)	1.009 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 13.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 28 Analysis	190.44 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22.4
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 7	1.020 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 28.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 112 (EOS) Analysis	187.13 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 23.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 14	1.000 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 10.4
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 14 Analysis	175.18 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 58.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Change from Baseline at Day 84	1.006 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 13.5
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Baseline for Day 84 Analysis	184.99 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 59.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	TG: Change from Baseline at Day 14	1.013 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 35.9
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 84 Analysis	187.20 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 23.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)	Chol: Baseline for Day 14 Analysis	188.97 milligrams per deciliter (mg/dL)	Geometric Coefficient of Variation 22

Comparison: Triglycerides: Day 28p-value: 0.957290% CI: [0.88, 1.12]ANCOVA

Comparison: Triglycerides: Day 42p-value: 0.737290% CI: [0.87, 1.1]ANCOVA

Comparison: Triglycerides: Day 56p-value: 0.601590% CI: [0.92, 1.17]ANCOVA

Comparison: Triglycerides: Day 84p-value: 0.726190% CI: [0.89, 1.19]ANCOVA

Comparison: Triglycerides: Day 112 (EOS)p-value: 0.989290% CI: [0.87, 1.15]ANCOVA

Comparison: Triglycerides: Day 7p-value: 0.017990% CI: [0.77, 0.95]ANCOVA

Comparison: Triglycerides: Day 14p-value: 0.112590% CI: [0.8, 1]ANCOVA

Comparison: Cholesterol: Day 7p-value: 0.085890% CI: [0.92, 1]ANCOVA

Comparison: Cholesterol: Day 14p-value: 0.009690% CI: [0.88, 0.97]ANCOVA

Comparison: Cholesterol: Day 28p-value: 0.028490% CI: [0.88, 0.98]ANCOVA

Comparison: Cholesterol: Day 42p-value: 0.13390% CI: [0.89, 1.01]ANCOVA

Comparison: Cholesterol: Day 56p-value: 0.203290% CI: [0.89, 1.01]ANCOVA

Comparison: Cholesterol: Day 84p-value: 0.114190% CI: [0.87, 1]ANCOVA

Comparison: Cholesterol: Day 112 (EOS)p-value: 0.134290% CI: [0.88, 1.01]ANCOVA

Comparison: Cholesterol: Day 7p-value: 0.077190% CI: [0.92, 1]ANCOVA

Comparison: Cholesterol: Day 14p-value: 0.15190% CI: [0.91, 1.01]ANCOVA

Comparison: Cholesterol: Day 28p-value: 0.074490% CI: [0.89, 1]ANCOVA

Comparison: Cholesterol: Day 42p-value: 0.836590% CI: [0.93, 1.06]ANCOVA

Comparison: Cholesterol: Day 56p-value: 0.609190% CI: [0.92, 1.05]ANCOVA

Comparison: Cholesterol: Day 84p-value: 0.362190% CI: [0.9, 1.03]ANCOVA

Comparison: Cholesterol: Day 112 (EOS)p-value: 0.503190% CI: [0.91, 1.04]ANCOVA

Comparison: Cholesterol: Day 7p-value: 0.924490% CI: [0.96, 1.04]ANCOVA

Comparison: Cholesterol: Day 14p-value: 0.23690% CI: [0.99, 1.08]ANCOVA

Comparison: Cholesterol: Day 28p-value: 0.69990% CI: [0.96, 1.07]ANCOVA

Comparison: Cholesterol: Day 42p-value: 0.15990% CI: [0.99, 1.11]ANCOVA

Comparison: Cholesterol: Day 56p-value: 0.425690% CI: [0.97, 1.09]ANCOVA

Comparison: Cholesterol: Day 84p-value: 0.490190% CI: [0.96, 1.09]ANCOVA

Comparison: Cholesterol: Day 112 (EOS)p-value: 0.364890% CI: [0.97, 1.09]ANCOVA

Comparison: Triglycerides: Day 14p-value: 0.029190% CI: [0.76, 0.96]ANCOVA

Comparison: Triglycerides: Day 7p-value: 0.889190% CI: [0.91, 1.12]ANCOVA

Comparison: Triglycerides: Day 14p-value: 0.481790% CI: [0.85, 1.07]ANCOVA

Comparison: Triglycerides: Day 28p-value: 0.602290% CI: [0.84, 1.09]ANCOVA

Comparison: Triglycerides: Day 42p-value: 0.44790% CI: [0.83, 1.07]ANCOVA

Comparison: Triglycerides: Day 56p-value: 0.434290% CI: [0.83, 1.07]ANCOVA

Comparison: Triglycerides: Day 84p-value: 0.089190% CI: [0.73, 0.99]ANCOVA

Comparison: Triglycerides: Day 112 (EOS)p-value: 0.22690% CI: [0.77, 1.04]ANCOVA

Comparison: Triglycerides: Day 7p-value: 0.032490% CI: [0.78, 0.97]ANCOVA

Comparison: Triglycerides: Day 28p-value: 0.575590% CI: [0.84, 1.09]ANCOVA

Comparison: Triglycerides: Day 42p-value: 0.30790% CI: [0.8, 1.05]ANCOVA

Comparison: Triglycerides: Day 56p-value: 0.775290% CI: [0.86, 1.12]ANCOVA

Comparison: Triglycerides: Day 84p-value: 0.180390% CI: [0.75, 1.03]ANCOVA

Comparison: Triglycerides: Day 112 (EOS)p-value: 0.241490% CI: [0.76, 1.05]ANCOVA

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).

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 56	0.875 millimole per liter (mmol/L)	Geometric Coefficient of Variation 17
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 14	0.876 millimole per liter (mmol/L)	Geometric Coefficient of Variation 19.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 14	1.021 millimole per liter (mmol/L)	Geometric Coefficient of Variation 23.6
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 84 Analysis	1.158 millimole per liter (mmol/L)	Geometric Coefficient of Variation 24.9
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 84 Analysis	2.725 millimole per liter (mmol/L)	Geometric Coefficient of Variation 30.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 14 Analysis	2.664 millimole per liter (mmol/L)	Geometric Coefficient of Variation 39.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 84	0.891 millimole per liter (mmol/L)	Geometric Coefficient of Variation 16.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 7	0.874 millimole per liter (mmol/L)	Geometric Coefficient of Variation 15
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 7	1.009 millimole per liter (mmol/L)	Geometric Coefficient of Variation 18.7
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 112 (EOS) Analysis	1.115 millimole per liter (mmol/L)	Geometric Coefficient of Variation 22.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 56	1.011 millimole per liter (mmol/L)	Geometric Coefficient of Variation 27.9
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 7 Analysis	2.647 millimole per liter (mmol/L)	Geometric Coefficient of Variation 39
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 112 (EOS)	1.004 millimole per liter (mmol/L)	Geometric Coefficient of Variation 14.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 28 Analysis	1.143 millimole per liter (mmol/L)	Geometric Coefficient of Variation 23.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 7 Analysis	1.059 millimole per liter (mmol/L)	Geometric Coefficient of Variation 30
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 56 Analysis	2.841 millimole per liter (mmol/L)	Geometric Coefficient of Variation 32
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 28	0.862 millimole per liter (mmol/L)	Geometric Coefficient of Variation 14.1
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 112 (EOS) Analysis	2.695 millimole per liter (mmol/L)	Geometric Coefficient of Variation 31.6
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 42	0.989 millimole per liter (mmol/L)	Geometric Coefficient of Variation 29.9
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 42 Analysis	1.172 millimole per liter (mmol/L)	Geometric Coefficient of Variation 26.9
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 14 Analysis	1.093 millimole per liter (mmol/L)	Geometric Coefficient of Variation 24.8
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 42 Analysis	3.070 millimole per liter (mmol/L)	Geometric Coefficient of Variation 28.7
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 42	0.888 millimole per liter (mmol/L)	Geometric Coefficient of Variation 19.4
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 112 (EOS)	1.010 millimole per liter (mmol/L)	Geometric Coefficient of Variation 18.7
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 28	0.996 millimole per liter (mmol/L)	Geometric Coefficient of Variation 27.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 56 Analysis	1.148 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 84	1.029 millimole per liter (mmol/L)	Geometric Coefficient of Variation 22.5
LMB763 100 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 28 Analysis	2.612 millimole per liter (mmol/L)	Geometric Coefficient of Variation 39.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 84 Analysis	1.016 millimole per liter (mmol/L)	Geometric Coefficient of Variation 26.6
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 7 Analysis	1.014 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 7	0.969 millimole per liter (mmol/L)	Geometric Coefficient of Variation 10
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 14 Analysis	1.014 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 14	0.982 millimole per liter (mmol/L)	Geometric Coefficient of Variation 13.4
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 28 Analysis	1.014 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 28	0.952 millimole per liter (mmol/L)	Geometric Coefficient of Variation 15.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 42 Analysis	1.007 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 42	0.941 millimole per liter (mmol/L)	Geometric Coefficient of Variation 15.5
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 56 Analysis	1.008 millimole per liter (mmol/L)	Geometric Coefficient of Variation 25.9
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 56	0.956 millimole per liter (mmol/L)	Geometric Coefficient of Variation 15.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 84	0.920 millimole per liter (mmol/L)	Geometric Coefficient of Variation 19.9
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 112 (EOS) Analysis	1.013 millimole per liter (mmol/L)	Geometric Coefficient of Variation 26.1
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 112 (EOS)	1.037 millimole per liter (mmol/L)	Geometric Coefficient of Variation 17.2
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 7 Analysis	2.591 millimole per liter (mmol/L)	Geometric Coefficient of Variation 40.6
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 7	1.076 millimole per liter (mmol/L)	Geometric Coefficient of Variation 20.2
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 14 Analysis	2.591 millimole per liter (mmol/L)	Geometric Coefficient of Variation 40.6
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 14	1.125 millimole per liter (mmol/L)	Geometric Coefficient of Variation 19.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 28 Analysis	2.553 millimole per liter (mmol/L)	Geometric Coefficient of Variation 40.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 28	1.092 millimole per liter (mmol/L)	Geometric Coefficient of Variation 23
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 42 Analysis	2.559 millimole per liter (mmol/L)	Geometric Coefficient of Variation 41
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 42	1.079 millimole per liter (mmol/L)	Geometric Coefficient of Variation 24.5
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 56 Analysis	2.527 millimole per liter (mmol/L)	Geometric Coefficient of Variation 42
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 56	1.091 millimole per liter (mmol/L)	Geometric Coefficient of Variation 24.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 84 Analysis	2.528 millimole per liter (mmol/L)	Geometric Coefficient of Variation 41.8
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 84	1.107 millimole per liter (mmol/L)	Geometric Coefficient of Variation 31.7
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 112 (EOS) Analysis	2.418 millimole per liter (mmol/L)	Geometric Coefficient of Variation 40
LMB763 50 mg	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 112 (EOS)	1.035 millimole per liter (mmol/L)	Geometric Coefficient of Variation 34.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 84 Analysis	2.498 millimole per liter (mmol/L)	Geometric Coefficient of Variation 36.8
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 28 Analysis	2.614 millimole per liter (mmol/L)	Geometric Coefficient of Variation 36.3
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 42	1.005 millimole per liter (mmol/L)	Geometric Coefficient of Variation 12.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 14 Analysis	1.206 millimole per liter (mmol/L)	Geometric Coefficient of Variation 28.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 28	1.017 millimole per liter (mmol/L)	Geometric Coefficient of Variation 15.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 42 Analysis	1.212 millimole per liter (mmol/L)	Geometric Coefficient of Variation 30.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 7 Analysis	1.206 millimole per liter (mmol/L)	Geometric Coefficient of Variation 28.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 42 Analysis	2.679 millimole per liter (mmol/L)	Geometric Coefficient of Variation 35.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 28	1.009 millimole per liter (mmol/L)	Geometric Coefficient of Variation 14.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 84	1.025 millimole per liter (mmol/L)	Geometric Coefficient of Variation 22.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 42	0.914 millimole per liter (mmol/L)	Geometric Coefficient of Variation 21.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 28 Analysis	1.221 millimole per liter (mmol/L)	Geometric Coefficient of Variation 28.9
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 7	1.017 millimole per liter (mmol/L)	Geometric Coefficient of Variation 12.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 56 Analysis	2.621 millimole per liter (mmol/L)	Geometric Coefficient of Variation 36
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 112 (EOS)	1.007 millimole per liter (mmol/L)	Geometric Coefficient of Variation 11.5
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 112 (EOS) Analysis	1.218 millimole per liter (mmol/L)	Geometric Coefficient of Variation 29.6
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 14	0.979 millimole per liter (mmol/L)	Geometric Coefficient of Variation 10
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 7 Analysis	2.628 millimole per liter (mmol/L)	Geometric Coefficient of Variation 34.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 84	1.031 millimole per liter (mmol/L)	Geometric Coefficient of Variation 12.5
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 112 (EOS)	1.026 millimole per liter (mmol/L)	Geometric Coefficient of Variation 19.9
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 7	0.977 millimole per liter (mmol/L)	Geometric Coefficient of Variation 17.1
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 84 Analysis	1.219 millimole per liter (mmol/L)	Geometric Coefficient of Variation 29.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 56	0.991 millimole per liter (mmol/L)	Geometric Coefficient of Variation 24.7
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 14 Analysis	2.666 millimole per liter (mmol/L)	Geometric Coefficient of Variation 34.3
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Change from Baseline at Day 56	1.022 millimole per liter (mmol/L)	Geometric Coefficient of Variation 13.9
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Baseline for Day 112 (EOS) Analysis	2.482 millimole per liter (mmol/L)	Geometric Coefficient of Variation 36.2
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	LDL: Change from Baseline at Day 14	0.998 millimole per liter (mmol/L)	Geometric Coefficient of Variation 14.3
Pooled Placebo	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol	HDL: Baseline for Day 56 Analysis	1.226 millimole per liter (mmol/L)	Geometric Coefficient of Variation 29.1

Comparison: LDL Cholesterol Friedwald: Day 42p-value: 0.219990% CI: [0.85, 1.02]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 56p-value: 0.492890% CI: [0.87, 1.06]ANCOVA

Comparison: HDL Cholesterol: Day 7p-value: 0.000590% CI: [0.87, 0.95]ANCOVA

Comparison: HDL Cholesterol: Day 14p-value: 0.000590% CI: [0.84, 0.94]ANCOVA

Comparison: HDL Cholesterol: Day 28p-value: 0.006290% CI: [0.86, 0.96]ANCOVA

Comparison: HDL Cholesterol: Day 42p-value: 0.121490% CI: [0.89, 1]ANCOVA

Comparison: HDL Cholesterol: Day 56p-value: 0.004390% CI: [0.84, 0.95]ANCOVA

Comparison: HDL Cholesterol: Day 84p-value: 0.261590% CI: [0.89, 1.02]ANCOVA

Comparison: HDL Cholesterol: Day 112 (EOS)p-value: 0.133190% CI: [0.88, 1.01]ANCOVA

Comparison: HDL Cholesterol: Day 7p-value: <0.000190% CI: [0.81, 0.89]ANCOVA

Comparison: HDL Cholesterol: Day 14p-value: 0.000190% CI: [0.83, 0.93]ANCOVA

Comparison: HDL Cholesterol: Day 28p-value: <0.000190% CI: [0.79, 0.88]ANCOVA

Comparison: HDL Cholesterol: Day 42p-value: 0.000290% CI: [0.81, 0.92]ANCOVA

Comparison: HDL Cholesterol: Day 56p-value: <0.000190% CI: [0.77, 0.88]ANCOVA

Comparison: HDL Cholesterol: Day 84p-value: 0.000290% CI: [0.78, 0.9]ANCOVA

Comparison: HDL Cholesterol: Day 112 (EOS)p-value: 0.22890% CI: [0.89, 1.02]ANCOVA

Comparison: HDL Cholesterol: Day 7p-value: 0.00990% CI: [0.89, 0.97]ANCOVA

Comparison: HDL Cholesterol: Day 14p-value: 0.623790% CI: [0.93, 1.04]ANCOVA

Comparison: HDL Cholesterol: Day 28p-value: 0.00890% CI: [0.87, 0.97]ANCOVA

Comparison: HDL Cholesterol: Day 42p-value: 0.010590% CI: [0.86, 0.97]ANCOVA

Comparison: HDL Cholesterol: Day 56p-value: 0.021790% CI: [0.86, 0.98]ANCOVA

Comparison: HDL Cholesterol: Day 84p-value: 0.003190% CI: [0.82, 0.94]ANCOVA

Comparison: HDL Cholesterol: Day 112 (EOS)p-value: 0.77490% CI: [0.95, 1.07]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 7p-value: 0.178390% CI: [0.89, 1.01]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 14p-value: 0.021990% CI: [0.84, 0.97]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 28p-value: 0.071990% CI: [0.85, 0.99]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 84p-value: 0.341990% CI: [0.85, 1.05]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 14p-value: 0.005290% CI: [1.05, 1.21]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 112 (EOS)p-value: 0.728190% CI: [0.88, 1.09]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 7p-value: 0.31890% CI: [0.97, 1.12]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 14p-value: 0.657690% CI: [0.95, 1.1]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 28p-value: 0.603590% CI: [0.9, 1.06]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 42p-value: 0.326190% CI: [0.96, 1.17]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 56p-value: 0.524690% CI: [0.94, 1.15]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 84p-value: 0.751990% CI: [0.92, 1.14]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 112 (EOS)p-value: 0.957790% CI: [0.89, 1.12]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 7p-value: 0.01690% CI: [1.03, 1.18]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 28p-value: 0.182290% CI: [0.99, 1.15]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 42p-value: 0.015990% CI: [1.04, 1.24]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 56p-value: 0.152490% CI: [0.99, 1.19]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 84p-value: 0.174990% CI: [0.98, 1.2]ANCOVA

Comparison: LDL Cholesterol Friedwald: Day 112 (EOS)p-value: 0.750390% CI: [0.92, 1.13]ANCOVA

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).

Time frame: Baseline to Days 42 and 84

Population: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 42 Analysis	33.646 micrograms per liter (ug/L)	Geometric Coefficient of Variation 72.2
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 42	1.002 micrograms per liter (ug/L)	Geometric Coefficient of Variation 49.5
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 84 Analysis	32.246 micrograms per liter (ug/L)	Geometric Coefficient of Variation 72.9
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 84	1.023 micrograms per liter (ug/L)	Geometric Coefficient of Variation 54
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 42 Analysis	9.023 micrograms per liter (ug/L)	Geometric Coefficient of Variation 31.3
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 42	1.016 micrograms per liter (ug/L)	Geometric Coefficient of Variation 22.8
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 84 Analysis	9.263 micrograms per liter (ug/L)	Geometric Coefficient of Variation 34.6
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 84	1.003 micrograms per liter (ug/L)	Geometric Coefficient of Variation 21.2
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 42 Analysis	242.99 micrograms per liter (ug/L)	Geometric Coefficient of Variation 17.5
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 42	1.060 micrograms per liter (ug/L)	Geometric Coefficient of Variation 14.6
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 84 Analysis	247.42 micrograms per liter (ug/L)	Geometric Coefficient of Variation 18.8
LMB763 100 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 84	1.073 micrograms per liter (ug/L)	Geometric Coefficient of Variation 17
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 84	1.036 micrograms per liter (ug/L)	Geometric Coefficient of Variation 10.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 42 Analysis	26.869 micrograms per liter (ug/L)	Geometric Coefficient of Variation 75.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 84 Analysis	7.859 micrograms per liter (ug/L)	Geometric Coefficient of Variation 27.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 42 Analysis	199.21 micrograms per liter (ug/L)	Geometric Coefficient of Variation 78.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 42	1.133 micrograms per liter (ug/L)	Geometric Coefficient of Variation 54.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 42	1.071 micrograms per liter (ug/L)	Geometric Coefficient of Variation 24.3
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 84 Analysis	193.32 micrograms per liter (ug/L)	Geometric Coefficient of Variation 83.6
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 84 Analysis	27.320 micrograms per liter (ug/L)	Geometric Coefficient of Variation 78.2
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 84	1.048 micrograms per liter (ug/L)	Geometric Coefficient of Variation 26.9
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 42 Analysis	7.850 micrograms per liter (ug/L)	Geometric Coefficient of Variation 28.2
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 84	1.254 micrograms per liter (ug/L)	Geometric Coefficient of Variation 51.4
LMB763 50 mg	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 42	1.017 micrograms per liter (ug/L)	Geometric Coefficient of Variation 11.9
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 84	1.071 micrograms per liter (ug/L)	Geometric Coefficient of Variation 64.9
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 42 Analysis	9.087 micrograms per liter (ug/L)	Geometric Coefficient of Variation 35.5
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 42	0.995 micrograms per liter (ug/L)	Geometric Coefficient of Variation 13.3
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 42	1.010 micrograms per liter (ug/L)	Geometric Coefficient of Variation 26.4
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Baseline for Day 84 Analysis	8.934 micrograms per liter (ug/L)	Geometric Coefficient of Variation 32.3
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	PIIINP: Change from Baseline at Day 84	1.004 micrograms per liter (ug/L)	Geometric Coefficient of Variation 20.1
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 84 Analysis	245.09 micrograms per liter (ug/L)	Geometric Coefficient of Variation 20.5
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 42 Analysis	39.282 micrograms per liter (ug/L)	Geometric Coefficient of Variation 74.9
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	HA: Change from Baseline at Day 42	1.111 micrograms per liter (ug/L)	Geometric Coefficient of Variation 77
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Baseline for Day 42 Analysis	254.37 micrograms per liter (ug/L)	Geometric Coefficient of Variation 23.1
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	HA: Baseline for Day 84 Analysis	40.865 micrograms per liter (ug/L)	Geometric Coefficient of Variation 79.5
Pooled Placebo	Change From Baseline in Fibrosis Biomarker Test	TIMP-1: Change from Baseline at Day 84	1.000 micrograms per liter (ug/L)	Geometric Coefficient of Variation 19.2

Comparison: HA: Day 42p-value: 0.73990% CI: [0.77, 1.19]ANCOVA

Comparison: HA: Day 84p-value: 0.308690% CI: [0.72, 1.08]ANCOVA

Comparison: HA: Day 42p-value: 0.28890% CI: [0.69, 1.08]ANCOVA

Comparison: HA: Day 84p-value: 0.444690% CI: [0.73, 1.12]ANCOVA

Comparison: HA: Day 42p-value: 0.412790% CI: [0.73, 1.11]ANCOVA

Comparison: HA: Day 84p-value: 0.807490% CI: [0.85, 1.25]ANCOVA

Comparison: PIIINP: Day 42p-value: 0.693590% CI: [0.88, 1.08]ANCOVA

Comparison: PIIINP: Day 84p-value: 0.914590% CI: [0.9, 1.09]ANCOVA

Comparison: PIIINP: Day 42p-value: 0.913190% CI: [0.91, 1.12]ANCOVA

Comparison: PIIINP: Day 84p-value: 0.998890% CI: [0.91, 1.1]ANCOVA

Comparison: PIIINP: Day 42p-value: 0.587390% CI: [0.94, 1.13]ANCOVA

Comparison: PIIINP: Day 84p-value: 0.90590% CI: [0.92, 1.1]ANCOVA

Comparison: TIMP-1: Day 42p-value: 0.145890% CI: [0.99, 1.11]ANCOVA

Comparison: TIMP-1: Day 84p-value: 0.204890% CI: [0.98, 1.12]ANCOVA

Comparison: TIMP-1: Day 42p-value: 0.105190% CI: [1, 1.12]ANCOVA

Comparison: TIMP-1: Day 84p-value: 0.071790% CI: [1.01, 1.15]ANCOVA

Comparison: TIMP-1: Day 42p-value: 0.808390% CI: [0.96, 1.06]ANCOVA

Comparison: TIMP-1: Day 84p-value: 0.536190% CI: [0.96, 1.09]ANCOVA

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).

Time frame: Baseline to Day 84 (Week 12)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Baseline for Day 84 Analysis	18.751 percentage of liver fat	Geometric Coefficient of Variation 37.4
LMB763 100 mg	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Change from Baseline at Day 84	0.648 percentage of liver fat	Geometric Coefficient of Variation 29.3
LMB763 50 mg	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Baseline for Day 84 Analysis	17.715 percentage of liver fat	Geometric Coefficient of Variation 42.6
LMB763 50 mg	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Change from Baseline at Day 84	0.681 percentage of liver fat	Geometric Coefficient of Variation 38.6
Pooled Placebo	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Baseline for Day 84 Analysis	17.476 percentage of liver fat	Geometric Coefficient of Variation 73.9
Pooled Placebo	Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)	Change from Baseline at Day 84	0.962 percentage of liver fat	Geometric Coefficient of Variation 22.2

p-value: 0.535490% CI: [0.83, 1.09]ANCOVA

p-value: <0.000190% CI: [0.59, 0.78]ANCOVA

p-value: <0.000190% CI: [0.63, 0.8]ANCOVA

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.

Time frame: Baseline to Day 84 (Week 12)

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Baseline for Day 84 Analysis	8.87 score on a scale	Standard Deviation 19.108
LMB763 100 mg	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Change from Baseline at Day 84	9.35 score on a scale	Standard Deviation 18.746
LMB763 50 mg	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Baseline for Day 84 Analysis	4.62 score on a scale	Standard Deviation 10.356
LMB763 50 mg	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Change from Baseline at Day 84	4.85 score on a scale	Standard Deviation 21.798
Pooled Placebo	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Baseline for Day 84 Analysis	9.68 score on a scale	Standard Deviation 19.552
Pooled Placebo	Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin	Change from Baseline at Day 84	2.03 score on a scale	Standard Deviation 24.037

p-value: 0.207390% CI: [-2.161, 16.178]ANCOVA

p-value: 0.201490% CI: [-2.106, 16.563]ANCOVA

p-value: 0.964590% CI: [-7.974, 8.414]ANCOVA

Secondary

Change From Baseline in Waist to Hip Ratio

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 42	0.01 ratio	Standard Deviation 0.077
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 84	0.00 ratio	Standard Deviation 0.043
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 28	0.00 ratio	Standard Deviation 0.039
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 56 Analysis	0.96 ratio	Standard Deviation 0.061
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 42 Analysis	0.96 ratio	Standard Deviation 0.061
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 56	-0.00 ratio	Standard Deviation 0.029
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 112 (EOS)	-0.00 ratio	Standard Deviation 0.03
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 112 (EOS) Analysis	0.96 ratio	Standard Deviation 0.059
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 84 Analysis	0.95 ratio	Standard Deviation 0.063
LMB763 100 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 28 Analysis	0.96 ratio	Standard Deviation 0.065
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 84 Analysis	0.96 ratio	Standard Deviation 0.055
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 84	-0.01 ratio	Standard Deviation 0.044
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 112 (EOS) Analysis	0.96 ratio	Standard Deviation 0.054
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 42 Analysis	0.95 ratio	Standard Deviation 0.056
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 112 (EOS)	0.00 ratio	Standard Deviation 0.05
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 42	-0.00 ratio	Standard Deviation 0.039
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 56 Analysis	0.96 ratio	Standard Deviation 0.054
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 56	-0.00 ratio	Standard Deviation 0.033
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 28	0.00 ratio	Standard Deviation 0.034
LMB763 50 mg	Change From Baseline in Waist to Hip Ratio	Baseline for Day 28 Analysis	0.96 ratio	Standard Deviation 0.055
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 112 (EOS)	-0.00 ratio	Standard Deviation 0.037
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Baseline for Day 28 Analysis	0.95 ratio	Standard Deviation 0.089
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 28	-0.00 ratio	Standard Deviation 0.039
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Baseline for Day 42 Analysis	0.96 ratio	Standard Deviation 0.086
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 42	0.00 ratio	Standard Deviation 0.036
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 56	-0.01 ratio	Standard Deviation 0.029
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Baseline for Day 84 Analysis	0.96 ratio	Standard Deviation 0.087
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Change from Baseline at Day 84	0.01 ratio	Standard Deviation 0.046
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Baseline for Day 112 (EOS) Analysis	0.96 ratio	Standard Deviation 0.087
Pooled Placebo	Change From Baseline in Waist to Hip Ratio	Baseline for Day 56 Analysis	0.96 ratio	Standard Deviation 0.087

Comparison: Day 28p-value: 0.992790% CI: [-0.015, 0.014]ANCOVA

Comparison: Day 42p-value: 0.279490% CI: [-0.007, 0.035]ANCOVA

Comparison: Day 56p-value: 0.903290% CI: [-0.012, 0.013]ANCOVA

Comparison: Day 84p-value: 0.416390% CI: [-0.009, 0.027]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.700190% CI: [-0.022, 0.014]ANCOVA

Comparison: Day 28p-value: 0.536790% CI: [-0.009, 0.021]ANCOVA

Comparison: Day 42p-value: 0.549690% CI: [-0.014, 0.03]ANCOVA

Comparison: Day 56p-value: 0.684490% CI: [-0.01, 0.016]ANCOVA

Comparison: Day 84p-value: 0.569590% CI: [-0.025, 0.012]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.801590% CI: [-0.021, 0.016]ANCOVA

Comparison: Day 28p-value: 0.492390% CI: [-0.008, 0.02]ANCOVA

Comparison: Day 42p-value: 0.6290% CI: [-0.025, 0.014]ANCOVA

Comparison: Day 56p-value: 0.742390% CI: [-0.009, 0.014]ANCOVA

Comparison: Day 84p-value: 0.127290% CI: [-0.032, 0.001]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.888390% CI: [-0.015, 0.017]ANCOVA

Secondary

Change From Baseline in Weight

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Change From Baseline in Weight	Baseline for Day 28 Analysis	99.07 kilogram (kg)	Standard Deviation 22.56
LMB763 100 mg	Change From Baseline in Weight	Change from Baseline at Day 28	-0.78 kilogram (kg)	Standard Deviation 1.591
LMB763 100 mg	Change From Baseline in Weight	Baseline for Day 42 Analysis	96.89 kilogram (kg)	Standard Deviation 22.135
LMB763 100 mg	Change From Baseline in Weight	Change from Baseline at Day 42	-1.04 kilogram (kg)	Standard Deviation 1.683
LMB763 100 mg	Change From Baseline in Weight	Baseline for Day 56 Analysis	97.07 kilogram (kg)	Standard Deviation 22.555
LMB763 100 mg	Change From Baseline in Weight	Change from Baseline at Day 56	-1.39 kilogram (kg)	Standard Deviation 1.97
LMB763 100 mg	Change From Baseline in Weight	Baseline for Day 84 Analysis	97.34 kilogram (kg)	Standard Deviation 23.37
LMB763 100 mg	Change From Baseline in Weight	Change from Baseline at Day 84	-1.47 kilogram (kg)	Standard Deviation 2.169
LMB763 100 mg	Change From Baseline in Weight	Baseline for Day 112 (EOS) Analysis	98.74 kilogram (kg)	Standard Deviation 23.941
LMB763 100 mg	Change From Baseline in Weight	Change from Baseline at Day 112 (EOS)	-1.26 kilogram (kg)	Standard Deviation 3.014
LMB763 50 mg	Change From Baseline in Weight	Baseline for Day 112 (EOS) Analysis	95.38 kilogram (kg)	Standard Deviation 14.81
LMB763 50 mg	Change From Baseline in Weight	Baseline for Day 28 Analysis	97.82 kilogram (kg)	Standard Deviation 17.829
LMB763 50 mg	Change From Baseline in Weight	Change from Baseline at Day 56	-1.39 kilogram (kg)	Standard Deviation 2.188
LMB763 50 mg	Change From Baseline in Weight	Baseline for Day 56 Analysis	97.86 kilogram (kg)	Standard Deviation 18.043
LMB763 50 mg	Change From Baseline in Weight	Change from Baseline at Day 28	-0.71 kilogram (kg)	Standard Deviation 1.725
LMB763 50 mg	Change From Baseline in Weight	Change from Baseline at Day 112 (EOS)	-1.66 kilogram (kg)	Standard Deviation 3.543
LMB763 50 mg	Change From Baseline in Weight	Change from Baseline at Day 84	-2.02 kilogram (kg)	Standard Deviation 3.451
LMB763 50 mg	Change From Baseline in Weight	Baseline for Day 42 Analysis	97.82 kilogram (kg)	Standard Deviation 17.829
LMB763 50 mg	Change From Baseline in Weight	Baseline for Day 84 Analysis	97.11 kilogram (kg)	Standard Deviation 17.905
LMB763 50 mg	Change From Baseline in Weight	Change from Baseline at Day 42	-1.08 kilogram (kg)	Standard Deviation 2.335
Pooled Placebo	Change From Baseline in Weight	Change from Baseline at Day 84	-0.21 kilogram (kg)	Standard Deviation 1.989
Pooled Placebo	Change From Baseline in Weight	Change from Baseline at Day 42	-0.24 kilogram (kg)	Standard Deviation 1.677
Pooled Placebo	Change From Baseline in Weight	Baseline for Day 56 Analysis	95.71 kilogram (kg)	Standard Deviation 23.244
Pooled Placebo	Change From Baseline in Weight	Change from Baseline at Day 56	-0.26 kilogram (kg)	Standard Deviation 1.777
Pooled Placebo	Change From Baseline in Weight	Baseline for Day 112 (EOS) Analysis	95.85 kilogram (kg)	Standard Deviation 23.926
Pooled Placebo	Change From Baseline in Weight	Baseline for Day 84 Analysis	95.91 kilogram (kg)	Standard Deviation 23.563
Pooled Placebo	Change From Baseline in Weight	Baseline for Day 28 Analysis	95.47 kilogram (kg)	Standard Deviation 22.921
Pooled Placebo	Change From Baseline in Weight	Change from Baseline at Day 112 (EOS)	0.35 kilogram (kg)	Standard Deviation 2.125
Pooled Placebo	Change From Baseline in Weight	Change from Baseline at Day 28	-0.17 kilogram (kg)	Standard Deviation 1.516
Pooled Placebo	Change From Baseline in Weight	Baseline for Day 42 Analysis	95.30 kilogram (kg)	Standard Deviation 23.465

Comparison: Day 28p-value: 0.840290% CI: [-0.724, 0.567]ANCOVA

Comparison: Day 42p-value: 0.760790% CI: [-0.927, 0.639]ANCOVA

Comparison: Day 56p-value: 0.640690% CI: [-1.037, 0.581]ANCOVA

Comparison: Day 84p-value: 0.818590% CI: [-1.294, 0.979]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.780490% CI: [-1.485, 1.057]ANCOVA

Comparison: Day 28p-value: 0.140390% CI: [-1.265, 0.07]ANCOVA

Comparison: Day 42p-value: 0.060390% CI: [-1.743, -0.117]ANCOVA

Comparison: Day 56p-value: 0.00990% CI: [-2.182, -0.506]ANCOVA

Comparison: Day 84p-value: 0.013490% CI: [-2.965, -0.609]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.008790% CI: [-3.439, -0.807]ANCOVA

Comparison: Day 28p-value: 0.160990% CI: [-1.13, 0.091]ANCOVA

Comparison: Day 42p-value: 0.079790% CI: [-1.524, -0.049]ANCOVA

Comparison: Day 56p-value: 0.015990% CI: [-1.872, -0.36]ANCOVA

Comparison: Day 84p-value: 0.011890% CI: [-2.684, -0.575]ANCOVA

Comparison: Day 112 (EOS)p-value: 0.007690% CI: [-3.072, -0.746]ANCOVA

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).

Time frame: Baseline to Day 84 (Week 12)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LMB763 100 mg	Change From to Baseline in Liver Stiffness	Baseline for Day 84 Analysis	7.689 kilopascal (kPa)	Geometric Coefficient of Variation 71.1
LMB763 100 mg	Change From to Baseline in Liver Stiffness	Change from Baseline at Day 84	0.955 kilopascal (kPa)	Geometric Coefficient of Variation 35.3
LMB763 50 mg	Change From to Baseline in Liver Stiffness	Baseline for Day 84 Analysis	6.082 kilopascal (kPa)	Geometric Coefficient of Variation 29.5
LMB763 50 mg	Change From to Baseline in Liver Stiffness	Change from Baseline at Day 84	1.053 kilopascal (kPa)	Geometric Coefficient of Variation 26.9
Pooled Placebo	Change From to Baseline in Liver Stiffness	Baseline for Day 84 Analysis	7.108 kilopascal (kPa)	Geometric Coefficient of Variation 52.5
Pooled Placebo	Change From to Baseline in Liver Stiffness	Change from Baseline at Day 84	1.041 kilopascal (kPa)	Geometric Coefficient of Variation 38.6

p-value: 0.951490% CI: [0.84, 1.21]ANCOVA

p-value: 0.516890% CI: [0.78, 1.12]ANCOVA

p-value: 0.37490% CI: [0.8, 1.07]ANCOVA

Secondary

Observed Maximum Plasma Concentration (Cmax) of LMB763

No statistical analysis was planned for this outcome measure.

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

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
LMB763 100 mg	Observed Maximum Plasma Concentration (Cmax) of LMB763	Day 42	2230 nanograms per milliliter (ng/mL)	Standard Deviation 1190
LMB763 100 mg	Observed Maximum Plasma Concentration (Cmax) of LMB763	Day 1	3080 nanograms per milliliter (ng/mL)	Standard Deviation 1360
LMB763 50 mg	Observed Maximum Plasma Concentration (Cmax) of LMB763	Day 42	1290 nanograms per milliliter (ng/mL)	Standard Deviation 690
LMB763 50 mg	Observed Maximum Plasma Concentration (Cmax) of LMB763	Day 1	1290 nanograms per milliliter (ng/mL)	Standard Deviation 620

Secondary

Time to Reach Maximum Concentration (Tmax) of LMB763

No statistical analysis was planned for this outcome measure.

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

Arm	Measure	Group	Value (MEDIAN)
LMB763 100 mg	Time to Reach Maximum Concentration (Tmax) of LMB763	Day 1	2.00 hour (h)
LMB763 100 mg	Time to Reach Maximum Concentration (Tmax) of LMB763	Day 42	2.03 hour (h)
LMB763 50 mg	Time to Reach Maximum Concentration (Tmax) of LMB763	Day 1	2.00 hour (h)
LMB763 50 mg	Time to Reach Maximum Concentration (Tmax) of LMB763	Day 42	2.02 hour (h)

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026

Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Alanine Aminotransferase (ALT) Levels

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

Accumulation Ratio (Racc) of LMB763

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

Change From Baseline in Body Mass Index (BMI)

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

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

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

Change From Baseline in Fibrosis Biomarker Test

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

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

Change From Baseline in Waist to Hip Ratio

Change From Baseline in Weight

Change From to Baseline in Liver Stiffness

Observed Maximum Plasma Concentration (Cmax) of LMB763

Time to Reach Maximum Concentration (Tmax) of LMB763