The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
This is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known Atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or Type 2 Diabetes Mellitus. Participants will be randomized in the ratio of 1:1 to receive either AZD4144 or placebo. This study will comprise of: * A screening period of 28 days. * The treatment duration will be up to 28 days. * The visit frequency will be weekly up to a Follow-up Visit, followed by a Final Follow-up Visit 28 days after the final dose of AZD4144.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
Research Site
Berlin, Germany
Number of Participants with Adverse Events (AEs)
The safety and tolerability of AZD4144 compared with placebo will be assessed.
Time frame: From Screening (Day -28 to Day -2) to final follow-up (Day 56)
Relative change from baseline in systemic interleukin-6 (IL-6) levels
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
Time frame: From baseline to 4 weeks
Relative change from baseline in systemic IL-18 levels
The effect of AZD4144 compared with placebo on circulating biomarker IL-18 will be assessed.
Time frame: From baseline to 4 weeks
Relative change from baseline in high-sensitivity C-reactive protein (hsCRP) levels
The effect of AZD4144 compared with placebo on circulating biomarker hsCRP will be assessed.
Time frame: From baseline to 4 weeks
Observed lowest concentration before the next dose is administered (Ctrough) of AZD4144
The pharmacokinetics (PK) of AZD4144 in participants with obesity will be assessed.
Time frame: From Day 1 to Day 28
Maximum observed drug concentration (Cmax) of AZD4144
The PK of AZD4144 in participants with obesity will be assessed.
Time frame: From Day 1 to Day 28
Time to reach maximum observed concentration (tmax) of AZD4144
The PK of AZD4144 in participants with obesity will be assessed.
Time frame: From Day 1 to Day 28
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