Research Site
Berlin, 14050, Germany
NCT Number: NCT06942923
The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
AZD4144 will be administered orally as per arms they have been assigned.
Placebo will be administered orally as per arms they have been assigned.
Time frame: From Screening (Day -28 to Day -2) to final follow-up (Day 56)
The safety and tolerability of AZD4144 compared with placebo will be assessed.
Time frame: From baseline to 4 weeks
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
Time frame: From baseline to 4 weeks
The effect of AZD4144 compared with placebo on circulating biomarker IL-18 will be assessed.
Time frame: From baseline to 4 weeks
The effect of AZD4144 compared with placebo on circulating biomarker hsCRP will be assessed.
Time frame: From Day 1 to Day 28
The pharmacokinetics (PK) of AZD4144 in participants with obesity will be assessed.
Time frame: From Day 1 to Day 28
The PK of AZD4144 in participants with obesity will be assessed.
Time frame: From Day 1 to Day 28
The PK of AZD4144 in participants with obesity will be assessed.
AstraZeneca
Industry
A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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