Change in peripheral insulin sensitivity was measured by the Matsuda Index. Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index. Matsuda Index=10,000/square root [FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)]. A Matsuda index of <2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

Intent to treat (ITT) population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Change in adipose insulin sensitivity was measured by Adipo-IR. Adipo-IR= (Fasting Serum free fatty acid (FFA) mmol/L x FPI μIU/mL). A higher Adipo-IR index indicates the worst disease state. A lower Adipo-IR Index is best. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Macrophage infiltration in adipose tissue was assessed in paraffin-embedded adipose punch biopsies by immunohistochemistry stained for cluster of differentiation 68 (CD68), cluster of differentiation 163 (CD163), C-C chemokine receptor type 2 (CCR2), C-C chemokine receptor type 5 (CCR5) and cluster of differentiation 206 (CD206). A reduction in infiltration indicates less inflammation. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.

CCR2 and CCR5 corresponding ligands' messenger ribonucleic acid (mRNA) gene expression were assessed in frozen adipose tissue by quantitative polymerase chain reaction (PCR). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint

Peripheral monocyte subsets (cluster of differentiation 14 (CD14/cluster of differentiation 16 (CD16)] were measured in fresh peripheral blood mononuclear cells (PBMCs) samples by flow cytometry. Monocyte results are reported for Total, Classical (CD14+CD16-), Intermediate (CD14+CD16+) and Non-classical (CD14lowCD16+). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of insulin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

QUICKI is used to measure insulin sensitivity. QUICKI = 1/(log FPI μIU/mL + log FPG mg/dL). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

HOMA-IR = (FPG mg/dL x FPI μIU/mL)/405. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

HOMA-%B= (20 × FPI)/(FPG - 3.5). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of glucagon. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of glucose.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of insulin.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(0-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(30-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(0-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(30-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of free fatty acids. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of adiponectin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

A fasting blood sample was collected and was sent to a central laboratory for analysis of resistin. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of FFA.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(0-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

AUC(30-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Liver biopsy were performed during Screening and at Week 24 only for participants diagnosed with NASH. NAFLD activity score was determined based on 3 components: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x) and hepatocellular ballooning (0=none to 2= many cells/prominent ballooning) for a total possible score of 0 to 8. A negative change from Baseline indicates improvement.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included in the analysis.

Liver biopsy were performed during Screening and at Week 24 for participants diagnosed with NASH. The NASH CRN Brunt/Kleiner Fibrosis Staging System Fibrosis Stages are: 0 (None), 1 (Perisinusoidal or periportal), 1A (Mild, zone 3, perisinusoidal), 1B (Moderate, zone 3, perisinusoidal), 1C (Portal/periportal), 2 (Perisinusoidal and portal/periportal), 3 (Bridging fibrosis) and 4 (Cirrhosis).

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included.

Blood was collected and was sent to a central laboratory for analysis of MCP-1. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of RANTES (regulated on activation normal T-cell expressed and secreted). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of MIP-1α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of MIP-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of IL-6. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of IL-8. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of hs-CRP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of TNF-α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of Hyaluronic Acid. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of CK-18. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of FGF-21. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of Mac-2BP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of CD95. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Blood was collected and was sent to a central laboratory for analysis of AFP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.

LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.

LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.

LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.

LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. The LIF Score ranges from 0=no liver disease to 4=severe liver disease. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.

LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.

ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.

A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.

Blood was collected and was sent to a central laboratory for analysis of ALT. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.

Blood was collected and was sent to a central laboratory for analysis of AST. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.

Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving study drug.

Safety Population included all participants who received at least one dose of study drug.

Vital signs included Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Respiratory Rate and Temperature. The investigator determined if the vital sign measurements were clinically relevant.

Safety Population included all participants who received at least one dose of study drug.

A standard 12 lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Safety Population included all participants who received at least one dose of study drug.

Pharmacokinetic (PK) Population included all participants in the safety population who received at least 1 dose of study drug and had at least 1 PK assessment.

Physical examination included assessment of the following body systems: Abdomen, Cardiovascular, Extremities, Head, Eyes, Ears, Nose, Throat, Lungs, Lymph Nodes, Neurological, Skin and Thyroid. The number of participants with any abnormal findings at Baseline and participants with any abnormal findings Post-Baseline are reported.

Safety Population included all participants who received at least one dose of study drug.