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

Last updated: May 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Hyponatremia

Hepatic Fibrosis

Treatment

AZD2389

Clinical Study ID

NCT06750276
D7930C00002
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: AZD2389
Phase: 2
Study Start date:
December 06, 2024
Estimated Completion Date:
December 08, 2025

Study Description

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

Connect with a study center

  • Research Site

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Research Site

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Research Site

    Rialto, California 92377
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30349
    United States

    Active - Recruiting

  • Research Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.