AZD7503 for Non-alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effects of a new treatment, AZD7503, for individuals with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). In the first part of the study, participants will undergo a liver biopsy to confirm their condition but will not receive the drug. In the second part, those with confirmed NAFLD or NASH will receive the treatment to assess its safety and effectiveness. The trial seeks adults with signs of NAFLD or NASH, such as unusual liver test results or imaging showing liver fat, who are not pregnant or likely to become pregnant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that any changes to medications within one month before screening are not allowed. This might mean you should maintain your current medication regimen without changes.
Is there any evidence suggesting that AZD7503 is likely to be safe for humans?
Research shows that AZD7503 is being tested for safety and tolerance in people with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Earlier studies injected AZD7503 under the skin to observe how the body processes the drug over time. These studies focus on identifying side effects and assessing how well participants tolerate the drug.
Since this trial is in an early stage, the main goal is to learn about the safety of AZD7503. Early-stage trials usually involve a small number of participants to closely monitor any side effects. Although specific results are not yet available, this careful monitoring helps quickly identify potential risks.
It's important to understand that reaching this stage of testing means the treatment has passed initial lab tests and is promising enough for human trials. However, a complete understanding of its safety will only emerge as more data is collected over time.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for non-alcoholic fatty liver disease (NAFLD), which often focus on lifestyle changes and medications that indirectly address liver health, AZD7503 directly targets hepatic HSD17B13 mRNA expression. This novel mechanism aims to reduce liver inflammation and damage from the root by knocking down a specific enzyme linked to liver disease progression. Researchers are excited about AZD7503 because it represents a more targeted therapeutic approach, potentially offering improved efficacy and safety for patients with NAFLD or NASH.
What evidence suggests that AZD7503 might be an effective treatment for non-alcoholic fatty liver disease?
Research shows that AZD7503, the investigational treatment in this trial, targets and reduces a specific liver enzyme called HSD17B13. This enzyme is linked to the development of liver conditions like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Early studies suggest that lowering HSD17B13 levels may help reduce liver inflammation and damage, major issues in these conditions. While researchers continue to gather detailed human data, treatments like AZD7503 that focus on genes show promise for improving long-term liver health in people with liver diseases. Initial findings indicate that this approach could effectively stop or slow the progression of the disease.36789
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 70 with suspected or confirmed non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). They must have certain lab values indicating liver issues, a BMI of at least 20 kg/m2, and histologic evidence of NAFLD/NASH. Women must be of non-childbearing potential.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part A - Baseline Assessment
Participants undergo a diagnostic liver biopsy to determine NAFLD Activity Score and fibrosis stage
Part B - Treatment
Participants receive multiple doses of AZD7503 and undergo repeat liver biopsy at the end-of-treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD7503
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology