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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-06

Study Completion Date

2025-07-28

Brief Summary

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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

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Detailed Description

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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

Conditions

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Liver Fibrosis Hepatic Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The total duration of study participation for each participant in Cohorts A and B will be approximately 63 days (9 weeks) and will include an up to 28-day screening period, a 28-day treatment period, and a follow-up visit seven days following completion of treatment.

Assessments will be conducted as described in the SoA.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This is a single-blind, randomized, placebo-controlled study with up to 2 study intervention cohorts that are participant and investigator-blinded.

Study Groups

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Cohort A

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.

Group Type OTHER

AZD2389

Intervention Type DRUG

Doses of AZD2389 or placebo will be administered orally.

Cohort B

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 Type OTHER

AZD2389

Intervention Type DRUG

Doses of AZD2389 or placebo will be administered orally.

Interventions

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AZD2389

Doses of AZD2389 or placebo will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No