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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

COSMOS Trial Summary

This trial is testing a new drug to treat NASH, with participants monitored for up to 22 weeks. They won't benefit but will help researchers learn more.

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.Check my eligibility
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.See study design
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.

COSMOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline and over placebo to Week 12 - ALT
Secondary outcome measures
Change from baseline over placebo to Week 12 - Pro-C3
Plasma concentration of AZD4831 (Ctrough)
Other outcome measures
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

COSMOS 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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,780 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,322 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for participants in this experiment?

"Clinicaltrials.gov lists this research trial as actively recruiting, having originally gone live on October 26th 2022 and most recently modified on November 25th 2022."

Answered by AI

What potential hazardous effects might be associated with AZD4831?

"The safety profile of AZD4831 has been assessed at a 2, as the current trial is in its second phase and there is data to back up claims about its security but none confirming efficacy."

Answered by AI

Does this research study accommodate persons aged 25 and older?

"The requirements for entry into this medical trial necessitates that participants are aged between 18 and 75. Separately, there exist 98 trials targeting those under the legal age of consent and 543 studies geared towards people over retirement age."

Answered by AI

How many participants have been accepted into this medical experiment?

"Affirmative. Evidence hosted on clinicaltrials.gov affirms that this medical research is in the midst of looking for candidates, having first been posted on October 26th 2022 and most recently updated November 25th 2022. The study requires 90 participants to be recruited from 9 different sites."

Answered by AI

How many medical centers have implemented this research protocol?

"Currently, 9 medical sites are recruiting patients to partake in this study. These locations span from Stanford and Miami all the way down to Tucson. To minimize travelling needs should you decide to enroll, it is best that you choose a site nearest your home area."

Answered by AI

Which demographic is considered most suitable for participating in this medical experiment?

"This study is enrolling 90 individuals aged 18-75 with non-cirrhotic, non-alcoholic steatohepatitis and fibrosis. All applicants must have maintained a stable weight for the last three months prior to screening (defined as 5% or less change), display NAS scores of 4+ with components like steatosis, lobular inflammation, and ballooning all registering at 1+, an ALT reading above the upper limit but below 300 U/L during screening, and either be male of non-childbearing potential or female using contraceptives in accordance with local regulations."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I never took anything for my liver I am willing to try something just to see if there's a cure or something that would help me with my liver.
PatientReceived no prior treatments
~50 spots leftby Apr 2025