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

NCT ID: NCT06942923

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2025-09-29

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 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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AZD4144

Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days.

Group Type: EXPERIMENTAL

AZD4144

Intervention Type: DRUG

AZD4144 will be administered orally as per arms they have been assigned.

Placebo

Participants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally as per arms they have been assigned.

Interventions

AZD4144

AZD4144 will be administered orally as per arms they have been assigned.

Intervention Type: DRUG

Placebo

Placebo will be administered orally as per arms they have been assigned.

Intervention Type: DRUG

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D9441C00004

Identifier Type: -

Identifier Source: org_study_id