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AZD7503 for Non-alcoholic Fatty Liver Disease
Study Summary
This trial tests a new drug to see if it's safe and effective for a type of liver disease called NASH.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have taken drugs targeting HSD17B13 for my condition.I have a liver transplant or liver disease, but not due to NASH or cirrhosis.I haven't had any major illnesses or surgeries in the last 4 weeks.My high blood pressure is not under control.I am HIV positive or have Hepatitis B or C.I have NASH with a fibrosis score of F1 to F3, or suspected NASH with type 2 diabetes for 5+ years or a BMI of 25-40 plus two other metabolic issues.I cannot become pregnant or get someone pregnant.
- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has this therapeutic intervention been officially recognized by the FDA?
"This new treatment has yet to be fully assessed, so its safety is estimated at a score of 1. As this is just a Phase 1 trial, there are only limited data points that support both efficacy and safety."
Does this research initiative admit individuals aged 55 and older?
"This clinical trial is designed for individuals aged 18 to 75, however there are 19 studies open for minors and 206 specific to elderly patients."
Are there many Canadian healthcare facilities conducting this clinical investigation?
"At present, 10 different clinical sites are running this trial. These clinics can be found in Hialeah, Port Orange and San Juan as well as other cities throughout the country. It is important to select a nearby clinic should you join the study so that travel requirements are kept at a minimum."
Are there any vacancies remaining for new participants in this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this trial is currently enrolling participants; it was first advertised in March of 2023 and was most recently updated last month in May. The study requires 60 individuals across 10 sites for recruitment."
To what extent is the group of participants being monitored in this clinical research?
"Affirmative, according to the information on clinicaltrials.gov this investigation is actively recruiting volunteers. The trial was first announced on March 31st 2023 and has been recently updated on May 25th 2023. 60 individuals are required from 10 different medical centres."
Are there any restrictions on who can partake in this research?
"Eligibility requirements to join this clinical trial are non-alcoholic fatty liver disease and an age between 18 and 75. The total number of participants being accepted is approximately 60 individuals."
What are the primary aims of this medical investigation?
"According to the trial sponsor, AstraZeneca, primary outcomes will be measured from pre-screening until final visit (up to 18 weeks). The number of subjects with adverse events (AEs) is one metric being tracked. Secondary outcome metrics include Area under the concentration-time curve from time 0 to infinity (AUCinf), Area under the concentration-time curve over the dosing interval (AUCtau), and Maximum observed plasma drug concentration (Cmax)."
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