220 Participants Needed

AZD2693 for Non-alcoholic Steatohepatitis with Fibrosis

(FORTUNA Trial)

Recruiting at 167 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Prior Safety DataThis treatment has passed at least one previous human trial

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.
See 5 more

Treatment Details

Interventions

  • AZD2693
  • Placebo
Trial OverviewThe 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
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

Find a Clinic Near You

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+