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

NCT06750276 | Completed Phase 2 Results FDA Drug

• 1 other identifier: D7930C00002
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 9

Brief 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

Conditions

Liver Fibrosis; Hepatic Cirrhosis

Keywords

Liver Fibrosis; Hepatic Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Notable Trends in Laboratory Assessments (Haematology, Coagulation, Clinical Chemistry, Fibrinolysis, and Urinalysis)

  The number of participants with notable trends in laboratory assessments (haematology, coagulation, clinical chemistry, fibrinolysis, and urinalysis) is presented. Notable trends were assessed based on evaluation of mean values over time, individual participant values, and clinically important abnormalities, including values outside predefined criteria.

  From screening up to and including Day 35

• Clinically Relevant Trends in Vital Signs (Blood Pressure, Pulse Rate, Oxygen Saturation, Body Temperature, and Respiration Rate), and 12-lead Electrocardiogram (ECG)

  The number of participants with clinically relevant trends in vital signs (blood pressure, pulse rate, oxygen saturation, body temperature, and respiration rate), and12-lead ECGs is presented. Clinically relevant trends were assessed based on trends or group changes over time, changes in individual participants over time, and individual clinically important abnormalities.

  From Screening up to and including Day 35

Secondary Outcomes (12)

• Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Cmax

  Day 1 and Day 28

• Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Tmax

  Day 1 and Day 28

• Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: t1/2 Lambda z

  Day 1 and Day 28

• Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: AUClast, AUCinf, and AUCtau

  Day 1 and Day 28

• Plasma and Urine Pharmacokinetic (PK) Parameters of AZD2389: Lambda z

  Day 1 and Day 28

Study Arms (2)

Cohort A

OTHER

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.

Drug: AZD2389

Cohort B

OTHER

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.

Drug: AZD2389

Interventions

AZD2389 DRUG

Doses of AZD2389 or placebo will be administered orally.

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Chandler, Arizona, 85224, United States

Location

Research Site

Rialto, California, 92377, United States

Location

Research Site

Atlanta, Georgia, 30349, United States

Location

Research Site

Morehead City, North Carolina, 28557, United States

Location

Research Site

Houston, Texas, 77079, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

San Juan, 00927, Puerto Rico

Location

Research Site

Cambridge, CB2 0QQ, United Kingdom

Location

Related Links

• d7930c00002\_Redacted CSR synopsis
• d7930c00002\_Redacted\_SAP
• d7930c00002\_Redacted\_CSP

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a single-blind, randomized, placebo-controlled study with up to 2 study intervention cohorts that are participant and investigator-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 27, 2024
• Study Start: December 6, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: July 6, 2026
• Results First Posted: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (7); GB (1); PR (1)