A study in healthy male and female participants of non-childbearing and childbearing potential who have overweight or obesity
The study will comprise of: * A Screening Period of maximum 32 days (from Day -35 to Day -3). * A Treatment Period of 6 weeks (Cohort 1), 12 weeks (Cohort 2 and 3) and 26 weeks (Cohort 4) during which the participants will receive the study drug during residency at clinical unit. * A Follow-up Visit after the last dose of study drug. This study with repeated dosing of AZD6234 consists of 4 cohorts. For cohorts 1,2 and 3, eligible participants will be randomized to AZD6234 and placebo in a 3:1 ratio. For Cohort 4, eligible participants will be randomized in a 4:1:4:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Research Site
Osaka, Japan
Number of participants with Adverse Events (AEs) and Serious Adverse Events(SAE)
The safety and tolerability of repeated subcutaneous (SC) doses of AZD6234 compared to placebo will be assessed.
Time frame: From Screening (Day -35 to Day -3) to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)
Maximum observed plasma drug concentration (Cmax)
The pharmacokinetics (PK) of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)
Area under the plasma concentration-time (AUClast)
The PK of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
The PK of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or Day 225 (Cohort 4)
Area under concentration time curve in the dosing interval (AUCtau)
The PK of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)
Change from baseline in body weight of participants
The effects of AZD6234 on body weight change from baseline with and without placebo correction will be assessed.
Time frame: From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)
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Change from baseline in Body Mass Index (BMI) of participants
The effects of AZD6234 on body weight change from baseline with and without placebo correction will be assessed.
Time frame: From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)
Percentage change from baseline in fasting insulin
The effects of AZD6234 compared to placebo on fasting insulin will be assessed.
Time frame: From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)
Change from baseline in absolute level of fasting insulin of participants
The effects of AZD6234 compared to placebo on fasting insulin will be assessed.
Time frame: From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)
Prevalence of anti-drug antibodies (ADAs) to AZD6234
The immunogenicity of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) or to Day 183 (Cohort 4)
Incidence of ADAs to AZD6234
The immunogenicity of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) to Day 183 (Cohort 4)
ADA titer
The immunogenicity of AZD6234 following repeated SC doses of AZD6234 will be assessed.
Time frame: Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) or to Day 183 (Cohort 4)