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

NCT06942923 | Completed Phase 1

• 1 other identifier: D9441C00004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Cardiorenal disease; Atherosclerotic cardiovascular disease; Chronic kidney disease; Type 2 Diabetes Mellitus; Atherosclerosis; Obesity

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events (AEs)

  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

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

  From baseline to 4 weeks

Secondary Outcomes (5)

• Relative change from baseline in systemic IL-18 levels

  From baseline to 4 weeks

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

  From baseline to 4 weeks

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

  From Day 1 to Day 28

• Maximum observed drug concentration (Cmax) of AZD4144

  From Day 1 to Day 28

• Time to reach maximum observed concentration (tmax) of AZD4144

  From Day 1 to Day 28

Study Arms (2)

AZD4144

EXPERIMENTAL

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

Drug: AZD4144

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AZD4144 DRUG

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

AZD4144

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Atherosclerosis; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 22, 2025
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

DE (1)