What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) include pioglitazone, vitamin E, GLP-1 receptor agonists like liraglutide, and SGLT2 inhibitors. Pioglitazone can cause weight gain, edema, and an increased risk of bone fractures. Vitamin E is generally well-tolerated but may increase the risk of hemorrhagic stroke and prostate cancer in some populations. GLP-1 receptor agonists, such as liraglutide, may cause gastrointestinal issues like nausea, vomiting, and diarrhea. SGLT2 inhibitors can lead to urinary tract infections, genital infections, and dehydration. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic Steatohepatitis (NASH). However, several drugs have been studied for their potential benefits in these conditions. These include lipid-lowering agents, such as statins, which have shown efficacy in reducing hepatic steatosis, and metformin, which has been associated with a decreased risk of hepatocellular carcinoma in patients with diabetes. Additionally, pioglitazone and vitamin E have been evaluated for their effects on liver histology in NASH patients. Ongoing research continues to explore various pharmacological interventions aimed at reducing liver fat, inflammation, and fibrosis in NAFLD/NASH patients.

What other types of research exist?

Promising novel alternatives for treating NAFLD/NASH in 2024 include the knockdown of HSD17B13 mRNA, as studied in the AZD7503 trials, and the use of GLP-1 receptor agonists like liraglutide, which have shown efficacy in reducing liver fat and inflammation. Additionally, SGLT2 inhibitors are being explored for their potential benefits in managing liver fibrosis and associated metabolic conditions.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 99 days for reporting.

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 more

Awards & 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

Do I qualify?Apply below to find out

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.