| 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), 98 days in total|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), 98 days in total|Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs, Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals as measured by digitial 12-lead ECG., Baseline until the follow-up period (28 days post last dose), 98 days in total|Number of participants with abnormal vital signs reported as TEAEs, Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital sign parameters (Systolic Blood Pressure, Diastolic Blood Pressure, Pulse, Respiration rate, body temperature)., Baseline until the follow-up period (28 days post last dose), 98 days in total|Number of Participants With Abnormal Physical Examinations Reported as TEAEs, Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and enocrine., Baseline until the follow-up period (28 days post last dose), 98 days in total|Area under the concentration-time curve (AUC) during the dosing interval (AUCtau), To characterize the PK profile of Cotadutide, Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.|Maximum observed concentration (Cmax), To characterize the PK profile of Cotadutide, Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.|Time to Cmax (tmax), To characterize the PK profile of Cotadutide, Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.|Trough plasma concentration (Ctrough), To characterize the PK profile of Cotadutide, Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs, Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urinalysis., Baseline until the follow-up period (28 days post last dose), 98 days in total | Secondary: Anti-drug antibodies (ADAs) to Cotadutide, To characterize the immunogenicity of Cotadutide, Day 1 of Up-titration treatment period through end of study, 98 days in total|Change in daily average glucose levels, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.|Change in 7-day average glucose levels, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period|Change in percentage time spent in hyperglycemia (> 140 mg/dL) over 24hours and over 7days, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period|Change in percentage time spent in target range (70 -140 mg/dL) over 24hours and over 7days, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period|Change in percentage time spent in the range (< 54 mg/dL) over 24hours and over 7days, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period|Change in estimated hemoglobin A1c (HbA1c), To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline through 21day treatment extension period, 70 days in total|Change in fasting plasma glucose (mg/dL), To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control, Baseline through 21day treatment extension period, 70 days in total|Change in HbA1c, To assess the effects of cotadutide, titrated up to the dose of 600 μg, on additional measures of glucose control, Baseline through 21day treatment extension period, 70 days in total|Percentage change in body weight, To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight, Baseline through 21day treatment extension period, 70 days in total|Absolute change in body weight, To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight, Baseline through 21day treatment extension period, 70 days in total|Proportion of subjects achieving > 5% body weight loss, To assess the effects of cotadutide, titrated up to the dose of 600 μg, on body weight, Baseline through 21day treatment extension period, 70 days in total|Change in coefficient of variation as measured by CGM over 7 days, To assess the effect of Cotadutide on glucose control as measured by continuous glucose monitoring (CGM), Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
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