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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

Study Summary

This trial is testing a new treatment for non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). A liver biopsy will be done to see if you qualify. If you do, you'll receive the treatment being studied.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Adverse Events (AEs).
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,767 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,425 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

AZD7503 (RNA Interference) Clinical Trial Eligibility Overview. Trial Name: NCT05560607 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Intervention/ Drug
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD7503 Highlights & Side Effects. Trial Name: NCT05560607 — Phase 1
AZD7503 (RNA Interference) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560607 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to enroll in this research project?

"Affirmative. Clinicaltrials.gov lists this ongoing medical study as presently recruiting participants after it was posted on August 12th, 2022 and last updated on November 17th, 2022. At present, the trial requires 5 volunteers from 2 different sites."

Answered by AI

How many participants are currently being recruited for this research trial?

"Affirmative. The information posted to clinicaltrials.gov affirms that this trial is open for recruitment, having first been advertised on August 12th 2022 and recently updated on November 17th 2022. A maximum of 5 patients will be accepted from two different medical centres."

Answered by AI

Am I allowed to enroll in this research study?

"This medical study seeks to recruit 5 participants aged between 18 and 70 who have a diagnosis of non-alcoholic fatty liver disease (NAFLD). Additionally, these patients must meet the following criteria: Part B inclusion requirements, Part A Inclusion Criteria, Over 18 and below 70 years old at signing informed consent forms., ALT readings greater than upper limit of normal (ULN), Imaging showing hepatic steatosis with controlled attenuation parameter higher than 290 dB/m or Fibroscan measurements registering over 7.1 kPa., Body Mass Index no less than 20 kg/m2., No childbearing potential for male and"

Answered by AI

Is this research endeavor welcoming participants above the age of eight decades?

"As stated in the trial's eligibility requirements, patients must be between 18 and 70 years old to join."

Answered by AI

Has the Intervention/Drug been granted regulatory acceptance?

"Due to the limited data that exists on Intervention/Drug, our team at Power assigned a rating of 1 for safety in this Phase 1 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease
2022. "Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05560607.
~7 spots leftby Apr 2025
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