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

Egyéb feltételek

• 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