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

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called AZD2693, which is given as an injection under the skin. It is aimed at adults with a specific liver condition and a certain genetic marker. The goal is to see if it can reduce liver damage and improve liver function.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.

I carry the PNPLA3 gene variant linked to liver disease.

I have NASH with moderate to severe liver damage.

Exclusion Criteria

I have a liver condition not caused by alcohol or viruses.

I have a history of severe liver disease.

My kidney function is low, with an eGFR under 40.

+5 more

Participant Groups

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.

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