Your session is about to expire
← Back to Search
RNA Interference
AZD7503 for Non-alcoholic Fatty Liver Disease
Phase 1
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 99 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called AZD7503 to treat adults with specific liver diseases (NAFLD or NASH) who cannot have children. The drug aims to reduce a harmful substance in the liver. Researchers will check if the drug is safe and how well it works by comparing liver samples over time.
Who is the study for?
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.
What is being tested?
The study tests AZD7503's effects on knocking down HSD17B13 mRNA in patients with NAFLD/NASH. Part A involves diagnosis without intervention; Part B treats confirmed cases with the drug to assess its pharmacokinetics, safety, and tolerability.
What are the potential side effects?
While specific side effects are not listed here, common ones related to similar interventions may include gastrointestinal discomfort, fatigue, headache, injection site reactions and potential liver-related symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 99 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~99 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Adverse Events (AEs).
Secondary study objectives
Accumulation ratio for AUC of AZD7503.
Accumulation ratio for Cmax (Rac Cmax) of AZD7503
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD7503
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention/ DrugExperimental Treatment1 Intervention
Investigation of the knockdown of hepatic HSD17B13 mRNA expression, PK, safety, and tolerability following multiple dose administration of AZD7503 in male participants and female participants of non-childbearing potential with NAFLD or NASH
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7503 Intervention
2022
Completed Phase 1
~20
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) include pioglitazone, liraglutide, and obeticholic acid. Pioglitazone, a PPARγ agonist, improves insulin sensitivity and reduces liver fat by promoting the storage of fatty acids in adipose tissue rather than the liver.
Liraglutide, a GLP-1 receptor agonist, decreases liver fat and inflammation by enhancing insulin secretion and reducing appetite, which leads to weight loss. Obeticholic acid, a bile acid analog, reduces liver fibrosis by activating the farnesoid X receptor (FXR), which decreases bile acid synthesis and inflammation.
These treatments are crucial for NAFLD patients as they target the underlying mechanisms of the disease, potentially preventing progression to more severe liver conditions such as cirrhosis and hepatocellular carcinoma.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,592 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,465 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Intervention/ Drug
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.