AZD2693 for Non-alcoholic Steatohepatitis with Fibrosis

(FORTUNA Trial)

Recruiting at 167 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

220 Participants Needed

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.

Treatment Details

Interventions

• AZD2693
• Placebo

Trial Overview 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.

Participant Groups

Group I: AZD2693 dose 2 Experimental Treatment 1 Intervention

Participants will receive AZD2693 dose 2

Group II: AZD2693 dose 1 Experimental Treatment 1 Intervention

Participants will receive AZD2693 dose 1

Group III: Placebo Placebo Group 1 Intervention

Participants in this arm will receive placebo

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

AstraZeneca K.K.

Collaborator

Trials

2

Recruited

650+