| Outcome Measures: |
Primary: Incidence of treatment-emergent adverse events (TEAEs), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Incidence of treatment-emergent serious adverse events (TESAEs), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Clinically important changes in 12-lead electrocardiogram (ECG), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Vital signs as measured by pulse rate (bpm), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Vital signs as measured by blood pressure (mmHg), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Physical examination (abnormality to be reported as part of adverse events), To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose|Clinical laboratory evaluations, To assess the safety and tolerability of Cotadutide, Baseline until the follow-up period, 28 days post-last dose | Secondary: Area under the concentration-time curve (AUC) during the dosing interval (AUCtau), To characterize the PK profile of Cotadutide, Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks|Maximum observed concentration (Cmax), To characterize the PK profile of Cotadutide, Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks|Time to Cmax (tmax), To characterize the PK profile of Cotadutide, Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks|Trough plasma concentration (Ctrough), To characterize the PK profile of Cotadutide, Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks|Anti-drug antibodies (ADAs) to Cotadutide, To characterize the immunogenicity of Cotadutide, At baseline through end of study, 98 days in total|Change in average glucose levels (mg/dL), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in coefficient of variation, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in percentage time spent in hyperglycemia (> 140 mg/dL), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in percentage time spent in normoglycemia (70 -140 mg/dL), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in percentage time spent in clinically significant hypoglycemia (< 54 mg/dL), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in estimated hemoglobin A1c (HbA1c), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), At baseline through end of study, 98 days in total|Change in fasting plasma glucose (mg/dL), To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control, At baseline through end of study, 98 days in total|Change in HbA1c, To assess the effect of Cotadutide on glucose control as measured by additional measrues of glucose control, At baseline through end of study, 98 days in total|Percentage change in body weight, To assess the effect of Cotadutide on body weight, At baseline through end of study, 98 days in total|Absolute change in body weight (kg), To assess the effect of Cotadutide on body weight, At baseline through end of study, 98 days in total|Proportion of subjects achieving > 5% body weight loss, To assess the effect of Cotadutide on body weight, At baseline through end of study, 98 days in total
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