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Unknown

AZD7503 for Non-alcoholic Fatty Liver Disease

Phase 1
Recruiting
Led By Linda Martinez, MD
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 day 1 and day 57: pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective for a type of liver disease called NASH.

Who is the study for?
This trial is for adults with suspected NASH, a liver condition. Participants must have a confirmed diagnosis or signs of fatty liver plus type 2 diabetes or obesity with additional metabolic issues. They should not be able to bear children and agree to the study's terms.Check my eligibility
What is being tested?
The trial tests AZD7503, given as an injection under the skin, against a placebo in people with suspected NASH. It aims to assess how safe it is, how well participants tolerate it, and its pharmacokinetics (how the drug behaves over time in the body).See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, changes in liver function tests, fatigue, gastrointestinal symptoms or other unexpected health issues related to drug activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 57: pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 57: pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose 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 subjects with adverse events (AEs)
Number of subjects with serious adverse events (SAEs)
Secondary outcome measures
Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK
Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK
Fraction of the dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2)) for urine PK
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo.
Group II: Cohort 2Experimental Treatment1 Intervention
Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo.
Group III: Cohort 1Experimental Treatment1 Intervention
Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7503
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,615 Total Patients Enrolled
16 Trials studying Non-alcoholic Fatty Liver Disease
3,444 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Linda Martinez, MDPrincipal InvestigatorOracle Clinical Research
Richard Mohammed, MDPrincipal InvestigatorProgressive Medical Research

Media Library

AZD7503 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05864391 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD7503 Highlights & Side Effects. Trial Name: NCT05864391 — Phase 1
AZD7503 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864391 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~30 spots leftby Apr 2025