Evaluating AZD2389 for liver fibrosis and compensated cirrhosis
A Phase 2a, Randomised, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Explore the Pharmacodynamic Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis
This study is testing a new drug called AZD2389 to see if it is safe and well-tolerated for people with liver fibrosis and compensated cirrhosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 10 sites (Chandler, Arizona and 9 other locations) |
| Trial ID | NCT06750276 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of AZD2389 in participants with liver fibrosis and compensated cirrhosis. It involves a randomized, double-blind, placebo-controlled design with two cohorts, each receiving either the drug or a placebo over a treatment period of 28 days. Participants will undergo multiple clinic visits and assessments to monitor the drug's pharmacokinetics and pharmacodynamics. The study will include approximately 36 participants, with a focus on those with presumed MASH/NASH or other steatotic liver diseases.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18 and older with presumed MASH/NASH or other steatotic liver diseases and fibrosis.
Not a fit: Patients with decompensated liver disease, other significant liver conditions, or those at high risk for complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from liver fibrosis and compensated cirrhosis.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in evaluating treatments for liver fibrosis, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key inclusions: * Males/females aged ≥ 18 years * Indications: Presumed MASH (cohort A) or other steatotic liver disease (cohort B) with fibrosis * No significant change in weight over the last 6 months * Barrier contraceptives use by males * Capable of informed consent * Judged to be suitable for study by investigator Key exclusions: * A condition that could put the participant at risk, influence the participant's ability to participate in the trial, interfere with evaluation of the study intervention or affect the interpretation of the results * Other causes of liver disease which are not the principal inclusion criteria for each cohort * Significant elevations in liver blood tests or platelets \<140 x10\^9/L * Decompensated liver disease, hepatobiliary cancer or listing for liver transplantation * Bleeding disorders or major bleeding risk * HIV infection or hepatitis B infection * Clinically significant cardiovascular (e.g. severe ischaemic heart disease, severe heart failure or cardiac dysrhythmia) or cerebrovascular disease within the past 3 months * Stage 2 hypertension * eGFR \<60ml/min/1.73m2 * Clinically significant gastrointestinal disease which can affect the interpretation of pharmacokinetic, safety, and tolerability data * Skin disorders or ongoing wound healing * Psychiatric disorders which may negatively affect participation in the trial. * Females of childbearing potential
Where this trial is running
Chandler, Arizona and 9 other locations
- Research Site — Chandler, Arizona, United States (Recruiting)
- Research Site — Rialto, California, United States (Recruiting)
- Research Site — Atlanta, Georgia, United States (Recruiting)
- Research Site — Morehead City, North Carolina, United States (Recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — San Antonio, Texas, United States (Recruiting)
- Research Site — San Antonio, Texas, United States (Recruiting)
- Research Site — San Juan, Puerto Rico (Recruiting)
- Research Site — Cambridge, United Kingdom (Recruiting)
- Research Site — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.