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AZD2693 for NASH

Phase 1
Waitlist Available
Led By Rohit Loomba, MD, MHSc
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 is testing a new drug for people with NASH, a liver disease, who also have a certain risk allele. The study will see if the drug is safe and effective.

Who is the study for?
This trial is for adults with Non-alcoholic Steatohepatitis (NASH) who are overweight, have specific genetic markers (PNPLA3 148M), and liver fibrosis but not cirrhosis. They must consent to use contraception and can provide a recent liver biopsy or agree to one if needed. People with severe kidney disease, blood disorders that increase bleeding risk, history of major bleeding, or other chronic liver diseases besides NASH cannot join.Check my eligibility
What is being tested?
The study tests AZD2693's safety and effects on the body when given as an injection to people with NASH. It compares different doses of AZD2693 against a placebo in participants with varying stages of liver fibrosis. The drug's behavior in the body (pharmacokinetics) and its impact on the disease process (pharmacodynamics) will be measured.See study design
What are the potential side effects?
While specific side effects for AZD2693 aren't listed here, common ones for similar treatments include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, fatigue, headaches, potential allergic reactions, and changes in liver enzymes.

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 participants with adverse events
Secondary outcome measures
Absolute change from baseline in Alanine Aminotransferase
Absolute change from baseline in Aspartate Aminotransferase
Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score
+45 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
15 participants will receive AZD2693 dose 3 and 5 participants will receive placebo
Group II: Cohort 3Experimental Treatment2 Interventions
15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo
Group III: Cohort 2Experimental Treatment2 Interventions
15 participants will receive AZD2693 dose 2 and 5 participants will receive placebo
Group IV: Cohort 1Experimental Treatment2 Interventions
15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2693
2020
Completed Phase 1
~200

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,274 Previous Clinical Trials
288,613,290 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,370 Patients Enrolled for Non-alcoholic Fatty Liver Disease
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,078 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
121 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Rohit Loomba, MD, MHScPrincipal InvestigatorDirector, NAFLD Research Center Director of Hepatology, Professor of Medicine Vice Chief, Division of Gastroenterology University of California at San Diego ACTRI Building, 1W202 9500 Gilman Drive La Jolla, CA, 92037-0887

Media Library

AZD2693 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04483947 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort 3, Cohort 4, Cohort 1, Cohort 2
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD2693 Highlights & Side Effects. Trial Name: NCT04483947 — Phase 1
AZD2693 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04483947 — Phase 1

Frequently Asked Questions

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

At how many sites is this empirical investigation being conducted?

"This clinical trial is currently enrolling patients from 17 sites, which are located in Washington, Durham and Indianapolis as well as other cities. It might be beneficial to pick the nearest location to avoid extensive travelling if you decide to join this study."

Answered by AI

How many participants are being taken into consideration for this research?

"Affirmative. Clinicaltrials.gov reveals that the medical trial, initially posted on November 6th 2020, is now actively recruiting subjects for participation. Seventeen sites will require 80 participants in total."

Answered by AI

Is there an age restriction to be eligible for the trial?

"According to the prerequisites for this medical study, willing participants must be 18 years old or older and no greater than 75 years of age."

Answered by AI

Has AZD2693 been granted regulatory authorization from the FDA?

"Data on AZD2693's safety and efficacy is limited, thus our team awarded it a score of 1."

Answered by AI

What is the ideal demographic to recruit for this research project?

"Prospective participants of this study must meet the criteria of having steatohepatitis and falling within the age range 18 to 75. The trial seeks inclusion for a total 80 individuals."

Answered by AI

Are there any open slots for participation in this scientific investigation?

"Affirmative. According to clinicaltrials.gov, this therapeutic trial is currently seeking applicants and was originally posted on November 6th 2020 with a most recent edit occurring on November 2nd 2022. Eighty participants will be enrolled from 17 different sites in total."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
2020. "A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04483947.
~16 spots leftby May 2025
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