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Study identifier: NCT07610837 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingBRAVO

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

Condition: Liver Fibrosis · Hepatic Cirrhosis  ·  Sponsor: AstraZeneca

PhasePhase 2
Planned participants104
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where20 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

AstraZeneca Clinical Study Information Center  ·  1-877-240-9479  ·  information.center@astrazeneca.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (20)

Research SiteChandler, Arizona, United StatesRecruiting
Research SiteTucson, Arizona, United StatesRecruiting
Research SiteJupiter, Florida, United StatesRecruiting
Research SiteMiami, Florida, United StatesRecruiting
Research SitePort Orange, Florida, United StatesRecruiting
Research SiteKansas City, Missouri, United StatesRecruiting
Research SiteSt Louis, Missouri, United StatesRecruiting
Research SiteLas Vegas, Nevada, United StatesRecruiting
Research SiteMorehead City, North Carolina, United StatesRecruiting
Research SiteRaleigh, North Carolina, United StatesRecruiting
Research SiteWestlake, Ohio, United StatesRecruiting
Research SiteYukon, Oklahoma, United StatesRecruiting

+ 8 more locations — full list on the registry record.

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