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A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
CompletedPhase 2
Sponsor: AstraZeneca
Conditions: Liver Fibrosis, Hepatic Cirrhosis
Interventions: AZD2389
Countries: United States, Puerto Rico, United Kingdom
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (9)
- Chandler, Arizona, United States
- Rialto, California, United States
- Atlanta, Georgia, United States
- Morehead City, North Carolina, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- San Antonio, Texas, United States
- San Juan, Puerto Rico
- Cambridge, United Kingdom