| Outcome Measures: |
Primary: Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks | Secondary: Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks|Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks|Change in body mass index from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks|Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks|Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population, up to 16 weeks|Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%, up to 16 weeks|Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss, up to 16 weeks|Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation, up to 16 weeks|Vital signs - Systolic blood pressure (mmHg) absolute change from baseline, up to 16 weeks|Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline, up to 16 weeks|Vital signs - Heart rate (beats/minute) absolute change from baseline, up to 16 weeks|Vital signs - Body weight (kg) absolute and percent change from baseline, up to 16 weeks|Safety clinical laboratories - complete blood count absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum sodium absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum potassium absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum total bilirubin absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum direct bilirubin absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum creatinine absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum uric acid absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum calcium absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum lipase absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum amylase absolute change from baseline, up to 16 weeks|Safety clinical laboratories - eGFR (calculated) absolute change from baseline, up to 16 weeks|Safety clinical laboratories - fasting serum glucose absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum albumin absolute change from baseline, up to 16 weeks|Safety clinical laboratories - serum total protein absolute change from baseline, up to 16 weeks|Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline, up to 16 weeks|Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline, up to 16 weeks|Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline, up to 16 weeks|Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline, up to 16 weeks|Safety clinical laboratories - serum calcitonin absolute change from screening, up to 16 weeks|ECG interval change from baseline absolute and categorical outliers >450ms, up to 16 weeks|Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events, up to 16 weeks
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