AZD2389 for Liver Cirrhosis

(BORANA Trial)

No longer recruiting at 7 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Disqualifiers: Decompensated liver disease, HIV, Hepatitis B, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD2389 for individuals with liver fibrosis and compensated cirrhosis. Researchers aim to assess the drug's safety, tolerability, and how the body processes it compared to a placebo. The trial includes two groups: one for individuals with presumed MASH or NASH (types of liver disease with fat buildup) and another for those with advanced fibrosis. Individuals who have not significantly changed their weight in the past six months and suspect they have these liver conditions may be suitable candidates. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand any specific requirements.

Is there any evidence suggesting that AZD2389 is likely to be safe for humans?

Research has shown that AZD2389 has undergone testing to assess its safety and tolerability. In animal studies, AZD2389 improved liver health, particularly when diet caused liver issues, suggesting potential benefits with minimal risks.

However, detailed information about side effects and human tolerability remains limited. As this trial is in an early stage, some safety information is available, but researchers are still learning about its effects on people. Participants should understand that while there is potential, more specific safety information for humans will emerge as the trials progress. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver cirrhosis, which often focus on managing symptoms and slowing disease progression, AZD2389 is designed to target the underlying fibrosis directly. Most current options, like lifestyle changes and medications such as ursodeoxycholic acid, aim to improve liver function but don’t address the fibrosis itself. AZD2389 stands out because it potentially halts or even reverses fibrosis by targeting specific cellular pathways involved in liver tissue scarring. This unique approach has researchers excited as it could lead to more effective management of liver cirrhosis, offering hope for reversing damage rather than just controlling symptoms.

What evidence suggests that AZD2389 might be an effective treatment for liver cirrhosis?

Research has shown that AZD2389 could be helpful in treating liver fibrosis. In animal studies, AZD2389 improved liver fibrosis more than a placebo, reducing it by 16% compared to just 5% in groups that didn't receive the treatment. This suggests it might slow or stop the progression of liver fibrosis. The drug targets specific processes involved in liver damage. In this trial, participants in Cohort A and Cohort B will be randomized to receive either AZD2389 or a placebo. These early results offer hope that AZD2389 could become a new treatment option for liver diseases like MASH and cirrhosis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with liver fibrosis and compensated cirrhosis. Participants should meet specific health criteria, but the provided information does not detail these requirements.

Inclusion Criteria

My weight has been stable for the last 6 months.

Judged to be suitable for study by investigator

Barrier contraceptives use by males

Exclusion Criteria

Psychiatric disorders which may negatively affect participation in the trial

I have skin conditions or wounds that are healing.

I am a woman who can become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 or 2 visits (in-person)

Treatment

Participants receive AZD2389 or placebo for 28 days with multiple clinic visits

4 weeks

5 visits (in-person), including 24-hour and 24-48 hour in-clinic stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AZD2389

Trial Overview The study tests AZD2389 against a placebo to see how safe it is, how well people can tolerate it, and how the body handles the drug in those with liver fibrosis and compensated cirrhosis.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 1 Intervention

Participants with SLD with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo.

Group II: Cohort A Experimental Treatment 1 Intervention

Participants with presumed MASH/NASH with fibrosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06750276

NCT06750276 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo ...

2. linkedin.com linkedin.com/pulse/preclinical-research-fap-related-targets-qm4lf

AstraZeneca's Approach with AZD2389 | KBI Project ... This compound has the potential to halt liver fibrosis progression, providing a promising new strategy and targeted therapeutic option for MASH treatment.

3. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7930C00002

A study to evaluate the safety, tolerability, PK, and PD ... The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo.

4. bioworld.com bioworld.com/articles/714598-fap-inhibitor-azd-2389-improves-liver-fibrosis-and-mash

FAP inhibitor AZD-2389 improves liver fibrosis and MASH Additionally, animals treated with AZD-2389 had increased improvement of liver fibrosis compared to animals on vehicle (16% vs. 5%, p=0.01), ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06846528

A Study to Investigate the Pharmacokinetics of AZD2389 ... The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy ...

6. acs.digitellinc.com acs.digitellinc.com/p/s/azd2389-a-first-in-class-candidate-drug-for-the-treatment-of-metabolic-dysfunction-associated-steatohepatitis-622940

AZD2389, a first in class candidate drug for the treatment of ... FAP inhibition led to increased intact a2-AP in vivo and improvements in NAFLD activity score and histological fibrosis were observed.

7. bioworld.com bioworld.com/articles/718746-fap-inhibitor-azd-2389-is-a-strong-candidate-for-mash-treatment

FAP inhibitor AZD-2389 is a strong candidate for MASH ... Finally, AZD-2389 treatment improved liver histology in monkeys with diet-induced MASH compared to vehicle, as shown by steatosis percentage, ...

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06750276/

Trial | NCT06750276 The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo ...