AZD2389 for Liver Fibrosis

(BRAVO Trial)

This trial examines a new treatment, AZD2389, to determine its safety and effectiveness for individuals with liver fibrosis related to steatotic liver disease, a condition where fat accumulates in the liver and causes scarring. The trial compares this treatment to a placebo, a pill without active medicine. Participants must have liver fibrosis and maintain a stable weight over the past six months. The goal is to assess whether AZD2389 can improve the liver condition without causing excessive side effects. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

The trial requires you to stop taking certain medications, specifically moderate or strong CYP3A4 or BCRP/OAT3 inhibitors/inducers, and anticoagulants or antiplatelets (except low-dose aspirin).

Research has shown that AZD2389 is generally safe and well-tolerated. Earlier studies found no serious side effects or major safety concerns with AZD2389. Participants in these studies did not experience any significant negative health outcomes. The body absorbs and processes the drug predictably. Overall, AZD2389 appears to be a safe treatment option for people with liver conditions.¹²³⁴⁵

Unlike the standard treatments for liver fibrosis, which often include lifestyle changes, medications like ursodeoxycholic acid, or in severe cases, liver transplant, AZD2389 takes a novel approach. This drug is administered orally and is designed to target the underlying mechanisms of fibrosis directly within the liver. Researchers are particularly excited about AZD2389 because it offers a potentially more direct and efficient way to halt or even reverse fibrosis progression, which current treatments do not effectively achieve. This could be a game-changer for patients with liver fibrosis, providing a more convenient and targeted treatment option.

Research has shown that AZD2389, which participants in this trial may receive, may help treat liver fibrosis. One study found that it reduced liver fibrosis by 16%, compared to only 5% in those who did not receive the treatment. This drug blocks a protein called FAP, linked to liver damage, leading to better liver health. Other research also shows that AZD2389 can improve liver conditions like non-alcoholic fatty liver disease. These findings suggest that AZD2389 could be effective for people with liver fibrosis.¹⁴⁵⁶⁷