A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity

Launched by ASTRAZENECA · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test a new medication called AZD4144 in people who are living with obesity. The main goals of the study are to see if the medication is safe to take, how well it is tolerated (meaning how easy it is for people to take without problems), and how it affects the body over time with daily oral doses. The trial is currently not recruiting participants, but it is intended for healthy adults aged between 65 and 74 years.

To be eligible for this study, participants must have a body mass index (BMI) between 30 and 45, which indicates obesity. They also need to have certain health markers and must pass a pregnancy test if they are female. Participants should not have a history of significant heart problems, diabetes, or other serious health issues that could affect their ability to take part in the study safely. If you qualify and choose to participate, you can expect to take the medication daily and attend follow-up visits to monitor your health during the study. This is an important step in understanding how AZD4144 might help people with obesity in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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).
• • Have a waist to hip ratio of ≥0.9 for male and ≥0.85 for female participants.
• Key Exclusion Criteria:
• • 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.