Status:
COMPLETED
A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
Detailed Description
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 dise...
Eligibility Criteria
Inclusion
- Key
- Serum hsCRP \> 2 milligrams per liter (mg/L).
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit (Visit 2).
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception to avoid pregnancy from the time of first administration of study intervention until 3 months after the Final Follow-up Visit.
- Have a body mass index (BMI) greater than or equal to (≥) 30 and less than or equal to (≤) 45 kilograms per meter\^2 (kg/m\^2).
- Key
Exclusion
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History of Myocardial infarction (MI), coronary revascularisation, stroke, revascularisation for peripheral arterial disease, or other pre-existing Cardiovascular (CV) diseases.
- History of Diabetes (Type 1 and Type 2) or glycated haemoglobin (HbA1c) ≥6.5%.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any skin disorder, history of, or ongoing clinically significant allergy/hypersensitivity.
- Clinically significant serious active and chronic infections within 60 days prior to randomization.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06942923
Start Date
April 22 2025
End Date
September 29 2025
Last Update
October 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Berlin, Germany, 14050