BORANA
Research type
Research Study
Full title
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)
IRAS ID
1011039
Contact name
Richard Torstenson
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
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.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0371
Date of REC Opinion
23 Jan 2025
REC opinion
Further Information Favourable Opinion