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AZD4831 for NASH with Fibrosis (COSMOS Trial)
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.
COSMOS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COSMOS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: AZD4831
- Group 2: Placebo
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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