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AZD2693 for Non-alcoholic Fatty Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Mexico D.F., MexicoNon-alcoholic Fatty Liver DiseaseAZD2693 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Intervention/ Drug

Study Objectives

1 Primary · 50 Secondary · Reporting Duration: 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

Week 12
Absolute change from baseline to Week 8 and Week 12 in liver fat content (LFC)
Percent change from baseline to Week 8 and Week 12 in liver fat content (LFC)
Baseline, Week 10
Change from baseline to Week 10 in PNPLA3 mRNA and protein expression (Cohort 4 only)
Day 57
Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2))
Cumulative amount of analyte excreted from time zero through the last sampling interval (Ae(0-last))
Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(0-last))
Fraction of dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2))
Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC (CLR)
Day 162
Accumulation ratio based on AUC (RacAUC)
Accumulation ratio based on Cmax (RacCmax)
Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz)
Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)
Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUCss (CLss/F)
Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing the apparent clearance (CL/F) by λz (Vz/F)
Area under the concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUClast + Clast/λz where Clast is the last observed quantifiable concentration (AUC)
Area under the concentration-time curve in the dose interval (AUCss)
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCss/D)
Area under the plasma concentration-time curve from time zero to 48 hours after dosing (AUC(0-48h))
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)
Maximum observed plasma drug concentration (Cmax)
Maximum observed plasma drug concentration at steady state (Cssmax)
Mean residence time (MRT)
Minimum observed drug concentration at steady state (Cssmin)
Observed maximum plasma concentration divided by the dose administered (Cmax/D)
Observed maximum plasma concentration divided by the dose administered (Cssmax/D)
Temporal change parameter in systemic exposure (TCP)
Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz)
Time delay between drug administration and the first observed concentration in plasma (tlag)
Time of the last quantifiable concentration (tlast)
Time to reach maximum observed plasma concentration (tmax)
Time to reach maximum observed plasma concentration at steady state (tssmax)
Day 1
Absolute change from baseline in disease-specific biomarkers
Absolute change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.
Absolute change from baseline in plasma pharmacodynamic biomarker
Absolute change from baseline β-Hydroxybutyrate and lipid profile
Percent change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.
Percent change from baseline in plasma pharmacodynamic biomarker
Percent change from baseline β-Hydroxybutyrate and lipid profile
Percentage change from baseline in disease-specific biomarkers
Week 32
Absolute change from baseline in Alanine Aminotransferase
Absolute change from baseline in Aspartate Aminotransferase
Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score
Absolute change from baseline in Gamma Glutamyl Transferase
Alanine Transaminase
Percent change from baseline in Aspartate Aminotransferase
Percent change from baseline in ELF score
Percent change from baseline in Gamma Glutamyl Transferase
Week 32
Number of participants with adverse events
Week 10
RNA, Messenger

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
AZD8630
1
Miricorilant - Fluvoxamine/Miricorilant
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Intervention/ Drug

Trial Design

4 Treatment Groups

Cohort 1
1 of 4
Cohort 3
1 of 4
Cohort 4
1 of 4
Cohort 2
1 of 4

Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: AZD2693 · Has Placebo Group · Phase 1

Cohort 1Experimental Group · 2 Interventions: AZD2693, Placebo · Intervention Types: Drug, Other
Cohort 3Experimental Group · 2 Interventions: AZD2693, Placebo · Intervention Types: Drug, Other
Cohort 4Experimental Group · 2 Interventions: AZD2693, Placebo · Intervention Types: Drug, Other
Cohort 2Experimental Group · 2 Interventions: AZD2693, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2693
2019
Completed Phase 1
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,017 Previous Clinical Trials
240,375,387 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease (NAFLD)
93 Patients Enrolled for Non-alcoholic Fatty Liver Disease (NAFLD)
ParexelIndustry Sponsor
281 Previous Clinical Trials
96,496 Total Patients Enrolled
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

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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