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Tests treatment safety and results for Liver Fibrosis
Official title Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
ClinicalTrials.gov ID: NCT07610837
What this study is testing
What is AZD2389?
AZD2389 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liver fibrosis.
Also referred to as Active IMP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Portal hypertension (LSM \>25 kPa or 20-25 kPa with platelets \ A6, MELD \>12, other chronic liver diseases, prior/planned liver transplant, or...
- 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...
- 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...
See the full eligibility 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
- Portal hypertension (LSM \>25 kPa or 20-25 kPa with platelets \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Port Orange, Florida, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Morehead City, North Carolina, United States
- Raleigh, North Carolina, United States
- Westlake, Ohio, United States
- Yukon, Oklahoma, United States
- Clarksville, Tennessee, United States
- Austin, Texas, United States
- Denison, Texas, United States
- Georgetown, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Tucson, Arizona, United States; Jupiter, Florida, United States; Miami, Florida, United States; Port Orange, Florida, United States; Kansas City, Missouri, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.