A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity
- Registration Number
- NCT06942923
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD4144 AZD4144 Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days. Placebo Placebo Participants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) From Screening (Day -28 to Day -2) to final follow-up (Day 56) The safety and tolerability of AZD4144 compared with placebo will be assessed.
Relative change from baseline in systemic interleukin-6 (IL-6) levels From baseline to 4 weeks The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
- Secondary Outcome Measures
Name Time Method Relative change from baseline in systemic IL-18 levels From baseline to 4 weeks The effect of AZD4144 compared with placebo on circulating biomarker IL-18 will be assessed.
Relative change from baseline in high-sensitivity C-reactive protein (hsCRP) levels From baseline to 4 weeks The effect of AZD4144 compared with placebo on circulating biomarker hsCRP will be assessed.
Observed lowest concentration before the next dose is administered (Ctrough) of AZD4144 From Day 1 to Day 28 The pharmacokinetics (PK) of AZD4144 in participants with obesity will be assessed.
Maximum observed drug concentration (Cmax) of AZD4144 From Day 1 to Day 28 The PK of AZD4144 in participants with obesity will be assessed.
Time to reach maximum observed concentration (tmax) of AZD4144 From Day 1 to Day 28 The PK of AZD4144 in participants with obesity will be assessed.
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany