Recruiting
Phase 2

AZD2389

Sponsor:

AstraZeneca

Code:

NCT07610837

Conditions

Liver Fibrosis

Hepatic Cirrhosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD2389

Placebo

Study Details

Brief 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.

Conditions

Liver Fibrosis

Hepatic Cirrhosis

Study ID

NCT07610837

Start date

May 7, 2026

Status verified date

Aug, 2026

Completion date

Jul 7, 2027

Anticipated

Primary completion date

Jul 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Doses of AZD2389 to be administered orally.

placebo comparator: Arm B

Doses of placebo to be administered orally.

Interventions

AZD2389

potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis.

Placebo

Oral administration

Primary outcome measure

  • Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24 [ Time Frame: 24 weeks ]
  • Reported quantity and severity of adverse events (AEs) [ Time Frame: Up to and including Day 197 ]
  • Number of participants with observed changes in blood pressure against baseline mmHg value [ Time Frame: Up to and including Day 197 ]
  • Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG) [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory results detected in urine samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with observed changes in heart rate (BPM) against baseline value [ Time Frame: Up to and including Day 197 ]
  • Number of participants with observed changes in Sp02 oxygen values against baseline measurement [ Time Frame: Up to and including Day 197 ]
  • Number of participants with observed changes in body temperature against baseline value [ Time Frame: Up to and including Day 197 ]
  • Number of participants with observed changes in respiratory rate against baseline value [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]
  • Number of participants with abnormal laboratory test results detected in blood samples [ Time Frame: Up to and including Day 197 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Chandler, Arizona, United States, 85224

Research Site

Recruiting

Tucson, Arizona, United States, 85712

Research Site

Recruiting

Jupiter, Florida, United States, 33458

Research Site

Recruiting

Miami, Florida, United States, 33122

Research Site

Recruiting

Port Orange, Florida, United States, 32127

Research Site

Recruiting

Kansas City, Missouri, United States, 64131

Research Site

Recruiting

St Louis, Missouri, United States, 63123

Research Site

Recruiting

Las Vegas, Nevada, United States, 89106

Research Site

Recruiting

Morehead City, North Carolina, United States, 28557

Research Site

Recruiting

Raleigh, North Carolina, United States, 27607

Research Site

Recruiting

Westlake, Ohio, United States, 44145

Research Site

Recruiting

Yukon, Oklahoma, United States, 73099

Research Site

Recruiting

Clarksville, Tennessee, United States, 37040

Research Site

Recruiting

Austin, Texas, United States, 78757

Research Site

Recruiting

Denison, Texas, United States, 75020

Research Site

Recruiting

Georgetown, Texas, United States, 78626

Research Site

Recruiting

Houston, Texas, United States, 77004

Research Site

Recruiting

Houston, Texas, United States, 77079

Research Site

Recruiting

San Antonio, Texas, United States, 78215

Research Site

Recruiting

San Antonio, Texas, United States, 78222

More Information

Sponsor

AstraZeneca

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Liver Fibrosis
  • Hepatic Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-01.