Investigating AZD4144 for safety and tolerability in people with obesity

A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Obesity

This study is testing a new medication called AZD4144 to see if it's safe and well-tolerated in people with obesity.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (industry)
• Locations: 1 site (Berlin)
• Trial ID: NCT06942923 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacodynamics of AZD4144 through repeated daily oral dosing in healthy participants with obesity. It is a placebo-controlled, parallel group study conducted at a single center, where participants will be randomized to receive either AZD4144 or a placebo. The study includes a 28-day screening period, a treatment duration of up to 28 days, and follow-up visits to monitor participants' health and response to the treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with obesity, defined as having a BMI between 30 and 45 kg/m² and specific waist-to-hip ratio criteria.

Not a fit: Patients with a history of significant cardiovascular or kidney diseases, or other clinically important disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for managing obesity and its related health risks.

How similar studies have performed: Other studies have shown promise in similar approaches, but the specific use of AZD4144 in this context is novel.

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.

Where this trial is running

Berlin

• Research Site — Berlin, Germany (RECRUITING)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Healthy Participants, Cardiorenal disease, Atherosclerotic cardiovascular disease, Chronic kidney disease, Type 2 Diabetes Mellitus, Atherosclerosis, Obesity