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Completed

NCT Number: NCT06942923

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

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.

Treatment and study plan

AZD4144

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

  2. Relative change from baseline in systemic interleukin-6 (IL-6) levels

    Time frame: From baseline to 4 weeks

    The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.

Secondary outcomes

  1. Relative change from baseline in systemic IL-18 levels

    Time frame: From baseline to 4 weeks

    The effect of AZD4144 compared with placebo on circulating biomarker IL-18 will be assessed.

  2. Relative change from baseline in high-sensitivity C-reactive protein (hsCRP) levels

    Time frame: From baseline to 4 weeks

    The effect of AZD4144 compared with placebo on circulating biomarker hsCRP will be assessed.

  3. Observed lowest concentration before the next dose is administered (Ctrough) of AZD4144

    Time frame: From Day 1 to Day 28

    The pharmacokinetics (PK) of AZD4144 in participants with obesity will be assessed.

  4. Maximum observed drug concentration (Cmax) of AZD4144

    Time frame: From Day 1 to Day 28

    The PK of AZD4144 in participants with obesity will be assessed.

  5. Time to reach maximum observed concentration (tmax) of AZD4144

    Time frame: From Day 1 to Day 28

    The PK of AZD4144 in participants with obesity will be assessed.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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