Your session is about to expire
← Back to Search
Other
AZD4831 for NASH with Fibrosis (COSMOS Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing a new drug called AZD4831 to see if it can help people with a liver condition known as NASH, which causes liver damage and scarring. The study involves adults who have been diagnosed with NASH but do not have cirrhosis. Researchers hope that AZD4831 will reduce liver inflammation and scarring.
Who is the study for?
Adults aged 18-75 with Non-alcoholic Steatohepatitis (NASH) and liver fibrosis, confirmed by biopsy, can join this trial. They should have a history of increased liver enzymes but no other liver diseases or recent use of weight loss drugs or treatments that could affect the fatty liver.
What is being tested?
The study is testing AZD4831 against a placebo to see its effects on NASH with fibrosis. Participants will be randomly assigned to either the drug or placebo for 12 weeks and monitored for an additional 4 weeks after treatment ends.
What are the potential side effects?
Specific side effects are not listed, but participants may experience unexpected reactions due to the experimental nature of AZD4831. The safety follow-up period helps identify any potential adverse events from the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline and over placebo to Week 12 - ALT
Secondary study objectives
Change from baseline over placebo to Week 12 - Pro-C3
Plasma concentration of AZD4831 (Ctrough)
Other study objectives
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD4831Experimental Treatment1 Intervention
AZD4831
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4831
2022
Completed Phase 3
~990
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) target reducing liver inflammation and fibrosis, which are critical in preventing disease progression. For instance, pioglitazone, a PPAR-gamma agonist, improves insulin sensitivity and reduces liver fat.
Obeticholic acid, a farnesoid X receptor agonist, decreases liver inflammation and fibrosis by modulating bile acid pathways. Additionally, GLP-1 receptor agonists like liraglutide enhance insulin secretion and reduce hepatic fat content.
These treatments are crucial for NAFLD patients as they address the underlying mechanisms of liver damage, potentially halting or reversing disease progression.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,471 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I have been taking a high dose of vitamin E for the last 6 months.I have used medications like steroids or methotrexate in the last 6 months.I have a liver condition not caused by NASH.I have not consumed more than the maximum weekly alcohol limit.My liver condition was confirmed as NASH by a biopsy within the last year.I have not used weight loss drugs in the last 3 months.I have not used obeticholic acid or any experimental NASH treatments in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: AZD4831
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.