AZD2389 for Liver Cirrhosis

(BORANA Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AstraZeneca

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body

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.

Research Team

Eligibility Criteria

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

I am 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• AZD2389 (Anti-fibrotic Agent)

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.

Participant Groups

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