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

October 6, 2025 updated by: AstraZeneca

A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD4144
Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days.
Drug: AZD4144
AZD4144 will be administered orally as per arms they have been assigned.
Placebo Comparator: Placebo
Participants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days.
Drug: Placebo
Placebo will be administered orally as per arms they have been assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Screening (Day -28 to Day -2) to final follow-up (Day 56)
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.
From baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 4 weeks
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.
From baseline to 4 weeks
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.
From Day 1 to Day 28
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.
From Day 1 to Day 28
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.
From Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 6, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9441C00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST /Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on AZD4144

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe