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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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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
4,368 Previous Clinical Trials
288,736,637 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,362 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

AZD4831 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05638737 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: AZD4831, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD4831 Highlights & Side Effects. Trial Name: NCT05638737 — Phase 2
AZD4831 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638737 — Phase 2
~42 spots leftby Oct 2025