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AZD2693 for Non-alcoholic Steatohepatitis with Fibrosis (FORTUNA Trial)

Phase 2
Recruiting
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 64 weeks
Awards & highlights

FORTUNA Trial Summary

This trial will test a new drug to treat non-alcoholic fatty liver disease, to see if it's safe, effective, & tolerated in people with a certain gene.

Who is the study for?
This trial is for adults aged 18-75 with non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis, who carry the PNPLA3 148M risk allele. They must have a liver biopsy showing NASH and fibrosis stage F2 or F3. Excluded are those with other liver diseases, severe kidney disease, abnormal blood counts or certain elevated liver enzymes.Check my eligibility
What is being tested?
The study tests AZD2693's effectiveness and safety in treating NASH with fibrosis among carriers of the PNPLA3 risk allele. Participants will receive either AZD2693 or a placebo through subcutaneous injections to compare outcomes between the two groups.See study design
What are the potential side effects?
While specific side effects of AZD2693 aren't listed, common reactions to subcutaneous injections may include pain at injection site, redness, swelling, itching and potential allergic reactions.

FORTUNA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~64 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
Secondary outcome measures
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
Other outcome measures
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results

FORTUNA Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD2693 dose 2Experimental Treatment1 Intervention
Participants will receive AZD2693 dose 2
Group II: AZD2693 dose 1Experimental Treatment1 Intervention
Participants will receive AZD2693 dose 1
Group III: PlaceboPlacebo Group1 Intervention
Participants in this arm 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?

AstraZeneca K.K.UNKNOWN
1 Previous Clinical Trials
375 Total Patients Enrolled
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,495 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,264 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

AZD2693 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05809934 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: AZD2693 dose 1, AZD2693 dose 2, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD2693 Highlights & Side Effects. Trial Name: NCT05809934 — Phase 2
AZD2693 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05809934 — Phase 2

Frequently Asked Questions

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

Might I be qualified to join this medical experiment?

"To be eligible for this medical trial, participants must have non-alcoholic fatty liver disease and fall between 18 to 75 years old. Currently 232 individuals are being recruited."

Answered by AI

Is entry into this clinical trial restricted to those aged under 85 years?

"This clinical trial requires that patients be between 18 and 75 years of age. There are 94 trials for minors and 560 for elderly individuals."

Answered by AI

How many participants are being monitored in this clinical research?

"Affirmative, the information available on clinicaltrials.gov attests to this specific trial's ongoing recruitment efforts. It was initially published on March 15th 2023 and most recently revised on April 26th of the same year; 232 participants are being sought from one hundred distinct sites."

Answered by AI

Has the first dosage of AZD2693 been given sanctioning from the FDA?

"Our team's assessment of AZD2693 dose 1 safety is a 2, as this Phase 2 trial provides some evidence for safety but none that confirms its efficacy."

Answered by AI

Is enrollment still available for this experimental treatment?

"Clinicaltrials.gov reports that this medical experiment is presently welcoming new participants. The trial was launched on March 15th 2023, and the details were most recently revised April 26th 2023."

Answered by AI

How many healthcare centers are presently conducting this clinical trial?

"This experiment is presently conducted in 100 different cities, with La Plata, Sao Jose Do Rio Preto and Mannheim being some of the more prominent sites. To reduce travel burden, participants should choose a clinic close to their home."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
2023. "A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05809934.
All > Liver Fibrosis > Nash
~105 spots leftby Nov 2025
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