| Outcome Measures: |
Primary: Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study., Day - 35 to Day 205|Number and percentage of participants with clinically significant changes from baseline in Vital Sign Parameters., Day - 35 to Day 205|Number and percentage of participants with clinically significant changes in ECG parameters., Day - 35 to Day 205|Number and percentage of participants with clinically significant changes from baseline in Clinical Laboratory Parameters, Day - 35 to Day 205|Area Under Concentration-Time Curve of AZD9550 following repeat weekly SC doses, * AUC from 0 to the time of the last measured concentration (AUClast) at first dose and last dose * AUC over a dosing interval (AUCtau) at first dose and last dose, Day 1 to Day 65|Maximum observed concentration of AZD9550 following repeat weekly SC doses, • Cmax at first dose and last dose, Day 1 to Day 65|Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses, • t1/2λz at first dose and last dose, Day 1 to Day 65|Time to maximum observed concentration of AZD9550 following repeat weekly SC doses, • tmax at first dose and last dose, Day 1 to Day 65|Apparent oral clearance of AZD9550 following repeat weekly SC doses, • CL/F at first dose and last dose, Day 1 to Day 65|Apparent volume of distribution of AZD9550 following repeat weekly SC doses, • Vz/F at first dose and last dose, Day 1 to Day 65|Ratio for AUC of AZD9550 following repeat weekly SC doses, • Rac AUCtau at last dose, Day 1 to Day 65|Ratio for Cmax of AZD9550 following repeat weekly SC doses, • Rac Cmax at last dose, Day 1 to Day 65 | Secondary: PD effect of AZD9550 on fasting glucose compared to placebo, • Absolute change in fasting glucose, From baseline to Week 4|PD effect of AZD9550 on fasting lipid profile compared to placebo, • Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and BHB, From baseline to Week 4|Absolute and percentage change in body weight from baseline, From baseline to Week 4|Incidence of anti-AZD9550 antibodies, • Incidence of ADA to AZD9550, From Day 1 to Day 65|Absolute change in percentage body fat from baseline, From baseline to Week 4|PD effect of AZD9550 on fasting glucose compared to placebo, • Absolute change in fasting glucose, From baseline to Week 5|PD effect of AZD9550 on fasting lipid profile compared to placebo, • Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglyceride, and BHB, From baseline to Week 5|Effect of AZD9550 on hepatic fat fraction versus placebo at Week 5, * Change in hepatic fat fraction as measured by MRI-PDFF * Percent change in hepatic fat fraction as measured by MRI-PDFF, From baseline to Week 5|PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo, * Percent change in glucose AUC(0-4h) measured by MMTT * Percent change in insulin AUC(0-4h) measured by MMTT * Percent change in c-peptide AUC(0-4h) measured by MMTT, From baseline to Week 5|Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses, * AUC from 0 to the time of the last measured concentration (AUClast) at the last dose * AUC over a dosing interval (AUCtau) at first dose and last dose, Day 1 to Day 72|Incidence of anti-AZD9550 antibodies, • Incidence of ADA to AZD9550, Day 1 to Day 72|PD effect of AZD9550 on fasting glucose compared to placebo, • Absolute change in fasting glucose, From baseline to Week 24|PD effect of AZD9550 on fasting lipid profile compared to placebo, • Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and BHB, From baseline to Week 24|The effect of AZD9550 on hepatic fat fraction versus placebo after 13 and 24 weeks of treatment, * Change in hepatic fat fraction as measured by MRI-PDFF * Percent change in hepatic fat fraction as measured by MRI-PDFF, From baseline to Weeks 13 and 24|Effects of AZD9550 compared to placebo on body weight, * Change in body weight * Percent change in body weight * Proportion of participants achieving ≥ 5% body weight loss * Proportion of participants achieving ≥ 10% body weight loss * Absolute change in percentage body fat, From baseline to Week 24|Change in daily (24 hours) average glucose levels as measured by CGM, From baseline to Day 176|Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS, From baseline to Weeks 13 and 24|Area Under concentration-time Curve of AZD9550 following repeat weekly SC doses, * AUC from 0 to the time of the last measured concentration (AUClast) at the first doses of each dose level and the last dose of MTD * AUC over a dosing interval (AUCtau) at the first doses of each dose level and the last dose of MTD, Day 1 to Day 169|Incidence of anti-AZD9550 antibodies, • Incidence of ADA to AZD9550, Day 1 to Day 205|Change in daily (24 hours) average glucose levels as measured by CGM, From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose|Change in 7-day average glucose levels as measured by CGM, From baseline to Weeks 1, 2, 3, 4, 5, and 6 and during 14 days post last dose|Change in coefficient of variation of glucose levels as measured by CGM over 7 days, From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose|Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours, From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose|Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days, From baseline to Weeks 1, 2, 3, 4, 5, and 6, and during 14 days post last dose|Change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS, From baseline to Week 5|Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS, From baseline to Week 5|Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS, From baseline to Week 5|Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS, From baseline to Week 5|Change in liver volume as measured by MRI, From baseline to Week 5|Absolute change in body weight, From baseline to Week 5|Percent change in body weight, From baseline to Week 5|Proportion of participants achieving ≥ 5% body weight loss, From baseline to Week 5|Proportion of participants achieving ≥ 10% body weight loss, From baseline to Week 5|Change in 7-day average glucose levels as measured by CGM, From baseline to Day 176|Change in coefficient of variation of glucose levels as measured by CGM over 7 days, From baseline to Day 176 and during 14 days post last dose|Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours, From baseline to Day 176|Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 -140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days, From baseline to Day 176 and during 14 days post last dose|Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS, From baseline to Weeks 13 and 24|Change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS, From baseline to Weeks 13 and 24|Percentage change in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS, From baseline to Weeks 13 and 24|Change in liver volume, visceral and SC fat as measured by MRI, From baseline to Weeks 13 and 24|Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550, • Titre of ADA to AZD9550, From Day 1 to 65|Maximum observed concentration of AZD9550 following repeat weekly SC doses, • Cmax at the last dose, Day to Day 72|Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses, • t1/2λz at the last dose, Day 1 to Day 72|Time to maximum observed concentration of AZD9550 following repeat weekly SC doses, • tmax at the last dose, Day 1 to Day 72|Apparent oral clearance of AZD9550 following repeat weekly SC doses, • CL/F at the last dose, Day 1 to day 72|Apparent volume of distribution of AZD9550 following repeat weekly SC doses, • Vz/F at the last dose, Day 1 to Day 72|Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550, • Titre of ADA to AZD9550, Day 1 to Day 72|Maximum observed concentration of AZD9550 following repeat weekly SC doses, • Cmax at the first doses of each dose level and the last dose of MTD, Day 1 to Day 169|Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses, • t1/2λz at the first doses of each dose level and the last dose of MTD, Day 1 to Day 169|Time to maximum observed concentration of AZD9550 following repeat weekly SC doses, • tmax at the first doses of each dose level and the last dose of MTD, Day 1 to Day 169|Apparent oral clearance of AZD9550 following repeat weekly SC doses, • CL/F at the first doses of each dose level and the last dose of MTD, Day 1 to Day 169|Apparent volume of distribution of AZD9550 following repeat weekly SC doses, • Vz/F at the first doses of each dose level and the last dose of MTD, Day 1 to day 169|Anti-AZD9550 antibody titre among participants with positive serum antibodies to AZD9550, • Titre of ADA to AZD9550, Day 1 to Day 205|Change in visceral and subcutaneous fat as measured by MRI, From baseline to week 5|PD effect of AZD9550 on glucose metabolism compared to placebo, • Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c, From baseline to Week 4|PD effect of AZD9550 on glucose metabolism compared to placebo, • Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c, From baseline to Week 5|PD effect of AZD9550 on glucose metabolism compared to placebo, • Percent change in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c, From baseline to Week 24|PD effect of AZD9550 on fasting insulin compared to placebo, • Absolute change in fasting insulin, From baseline to Week 4|PD effect of AZD9550 on fasting c-peptide compared to placebo, • Absolute change in fasting c-peptide, From baseline to Week 4|PD effect of AZD9550 on fasting insulin compared to placebo, • Absolute change in fasting insulin, From baseline to Week 24|PD effect of AZD9550 on fasting c-peptide compared to placebo, • Absolute change in fasting c-peptide, From baseline to Week 24|PD effect of AZD9550 on fasting insulin compared to placebo, • Absolute change in fasting insulin, From baseline to Week 5|PD effect of AZD9550 on fasting c-peptide compared to placebo, • Absolute change in fasting c-peptide, From baseline to Week 5|Absolute change in percentage body fat, From baseline to Week 5|PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo, * Percent change in glucose AUC(0-4h) measured by MMTT * Percent change in insulin AUC(0-4h) measured by MMTT * Percent change in c-peptide AUC(0-4h) measured by MMTT * Absolute change in fasting glucose, fasting insulin, and fasting c-peptide * Percent change in fasting glucose, fasting insulin, and fasting c-peptide, From baseline to Week 13 and Week 24|PD effect of AZD9550 on fasting lipid profile compared to placebo, Absolute and percentage change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and HB, From baseline to week 24|PD effect of AZD9550 on HbA1c compared to placebo, Absolute change in HbA1c, From baseline to Week 4|PD effect of AZD9550 on HbA1c compared to placebo, Absolute change in HbA1c, From baseline to Week 5|PD effect of AZD9550 on HbA1c compared to placebo, Absolute change in HbA1c, From baseline to Week 24
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