Completed Digestion, Kidneys & Other Organs NIHR-supported project

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 (BORANA)

In plain English

AI plain-English summary

AstraZeneca’s experimental drug AZD2389 is being tested in 36 people with liver fibrosis and compensated cirrhosis to see if it is safe and how the body processes it. Liver fibrosis—scarring of the liver—can progress to cirrhosis, where the liver struggles to function. Currently, no approved drugs directly reverse fibrosis. This early-stage trial (Phase 2a) randomly assigns two-thirds of participants to receive AZD2389 and one-third to a placebo for 28 days, with follow-up lasting about nine weeks. Researchers will track side effects, vital signs, ECGs, blood tests, and imaging to measure how the drug acts on the body. If AZD2389 proves safe and shows signs of biological activity, it could open the door to larger trials aimed at slowing or reversing liver scarring. That would matter because liver fibrosis affects millions of people worldwide, often silently, and currently has no treatment beyond managing underlying causes like fatty liver disease or hepatitis. A drug that directly targets fibrosis could eventually reduce the need for liver transplants and prevent progression to liver failure. For now, this is a safety and dosing study—success means the drug is well-tolerated enough to move forward.

View original technical description
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 (study drug) as compared to placebo in participants with liver fibrosis and compensated (stable) cirrhosis. The study will also examine how the drug acts on the body.Approximately 36 participants from sites in the United Kingdom and United States, will be assigned by chance to receive AZD2389 or placebo (a substance which looks like the study treatment, but contains no active drug substance). There is a 67% chance of receiving AZD2389 and 33% chance of receiving placebo.The total duration of study participation for each participant will be approximately 9 weeks and will include a 28-day treatment period.The safety and tolerability of AZD2389 will be assessed through adverse event reporting, vital signs, ECG, physical examination, and laboratory assessments. How the drug acts on the body will be measured through blood laboratory assessments and imaging.

Researchers

Michael Allison (Principal Investigator)

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Original classification

Immunity, Inflammation and Transplantation

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.