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NCT07610837PHASE2Recruiting

Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis

AstraZeneca

Start Date

5/7/2026

Completion Date

7/7/2027

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.

Detailed Description

Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks. Disclosure Statement: This is a parallel group treatment study that is blinded to the participants and investigators. Number of Participants: Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo. Note: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process. Study Arms and Duration: Arm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Males/females aged 18 or over * A diagnosis of SLD with advanced fibrosis * No significant change in weight over the last 6 months * Contraceptive us by participants or participants partners * Capable of giving informed consent * Judged by the investigator to be suitable for study Key Exclusion Criteria: * Portal hypertension (LSM \>25 kPa or 20-25 kPa with platelets \<150×10⁹/L), decompensated liver disease, Child-Pugh \>A6, MELD \>12, other chronic liver diseases, prior/planned liver transplant, or malignant liver tumors. * Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment. * Alcohol intake above protocol thresholds, or positive screen for drugs of abuse. * Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac/cerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery. * History of psychosis, bipolar disorder, recent major depression, or suicide attempt/ideation within 1 year. * Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions. * Prohibited medications or hypersensitivities, including moderate/strong CYP3A4 or BCRP/OAT3 inhibitors/inducers, anticoagulants/antiplatelets (except aspirin ≤81 mg/day), or hypersensitivity to DPP4 inhibitors. * Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT/AST), recent participation in another IMP study, or investigator judgment of unsuitability.

Interventions

DRUG

AZD2389

OTHER

Placebo

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Conditions

Liver FibrosisHepatic Cirrhosis

Locations

Research Site

Chandler, Arizona 85224

United States

Research Site

Tucson, Arizona 85712

United States

Research Site

Jupiter, Florida 33458

United States

Research Site

Miami, Florida 33122

United States

Research Site

Port Orange, Florida 32127

United States

Research Site

Kansas City, Missouri 64131

United States

Research Site

St Louis, Missouri 63123

United States

Research Site

Las Vegas, Nevada 89106

United States

Research Site

Morehead City, North Carolina 28557

United States

Research Site

Raleigh, North Carolina 27607

United States

Research Site

Westlake, Ohio 44145

United States

Research Site

Yukon, Oklahoma 73099

United States

Research Site

Clarksville, Tennessee 37040

United States

Research Site

Austin, Texas 78757

United States

Research Site

Denison, Texas 75020

United States

Research Site

Georgetown, Texas 78626

United States

Research Site

Houston, Texas 77004

United States

Research Site

Houston, Texas 77079

United States

Research Site

San Antonio, Texas 78215

United States

Research Site

San Antonio, Texas 78222

United States