A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.

Investigating the Safety and Effects of an Investigational Medication in Liver Scarring and Functioning

Recruiting
18 years or above
All
Phase 2
36 participants needed
5 Locations

Study Overview

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.

Study Details

Study details include:

The study duration will be up to 63 days (9 weeks).

  • 1 or 2 screening visits (up to 28 days before treatment)
  • 28 days of treatment including 5 clinic visits
  • Week 1: 24-hour in-clinic stay (Day 1)
  • Week 2: Outpatient clinic visit (Day 7)
  • Week 3: Outpatient clinic visit (Day 14)
  • Week 4: Telephone visit (Day 21)
  • Week 5: 24 to 48-hour in-clinic stay (Day 28)
  • Week 6: Follow-up visit (Day 35) Disclosure Statement: The study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation.

Number of Participants:

The study will randomise approximately 36 participants in total. Cohort A: Approximately 75 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. Cohort B: Approximately 75 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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Liver Fibrosis, Hepatic Cirrhosis
  • Age: 18 years or above
  • Gender: All

Key inclusions:

  • Males/females aged ≥ 18 years
  • Indications: Presumed MASH (cohort A) or other steatotic liver disease (cohort B) with fibrosis
  • No significant change in weight over the last 6 months
  • Barrier contraceptives use by males
  • Capable of informed consent
  • Judged to be suitable for study by investigator

Key exclusions:

  • A condition that could put the participant at risk, influence the participant's ability to participate in the trial, interfere with evaluation of the study intervention or affect the interpretation of the results
  • Other causes of liver disease which are not the principal inclusion criteria for each cohort
  • Significant elevations in liver blood tests or platelets <140 x10^9/L
  • Decompensated liver disease, hepatobiliary cancer or listing for liver transplantation
  • Bleeding disorders or major bleeding risk
  • HIV infection or hepatitis B infection
  • Clinically significant cardiovascular (e.g. severe ischaemic heart disease, severe heart failure or cardiac dysrhythmia) or cerebrovascular disease within the past 3 months
  • Stage 2 hypertension
  • eGFR <60ml/min/1.73m2
  • Clinically significant gastrointestinal disease which can affect the interpretation of pharmacokinetic, safety, and tolerability data
  • Skin disorders or ongoing wound healing
  • Psychiatric disorders which may negatively affect participation in the trial.
  • Females of childbearing potential

Updated on 31 Jan 2025. Study ID: NCT06750276

This study investigates the safety and effects of an investigational medication compared to a placebo in people with liver fibrosis and compensated cirrhosis. Liver fibrosis is a condition where scar tissue forms in the liver due to injury or long-term damage. Compensated cirrhosis means the liver is scarred but still able to function. The purpose of this study is to understand how the investigational medication is absorbed, distributed, and metabolized by the body.

Participants will undergo several procedures during the study. These include screening visits, a treatment period with five clinic visits, and follow-up. Some visits will involve staying in the clinic for 24 to 48 hours. The study will also involve telephone check-ins to monitor participants' progress. Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Adults aged 18 and older with liver fibrosis and compensated cirrhosis can participate. They should not have had significant weight changes in the last 6 months and must use barrier contraceptives if male. Participants must be able to give informed consent and be deemed suitable by the investigator.
  • Study details: Participants will attend clinic visits and may need to stay overnight for monitoring and assessments.
  • Study Timelines and Visits: The study will last 63 days. The study requires 5 visits.

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