A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With … (NCT06750276) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
United States, Puerto Rico, United Kingdom40 participantsStarted 2024-12-06
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Notable Trends in Laboratory Assessments (Haematology, Coagulation, Clinical Chemistry, Fibrinolysis, and Urinalysis)
Timeframe: From screening up to and including Day 35
2
Clinically Relevant Trends in Vital Signs (Blood Pressure, Pulse Rate, Oxygen Saturation, Body Temperature, and Respiration Rate), and 12-lead Electrocardiogram (ECG)
Timeframe: From Screening up to and including Day 35