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

AstraZeneca

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AZD4144; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06942923

D9441C00004

Details and patient eligibility

About

The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

AZD4144

Experimental group

Description:

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

Treatment:

Drug: AZD4144

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo