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A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis (FORTUNA)

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ClinicalTrials.gov Identifier: NCT05809934
Recruitment Status : Recruiting
First Posted : April 12, 2023
Last Update Posted : April 12, 2024
Sponsor:
Collaborator:
AstraZeneca K.K.
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: AZD2693 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : November 7, 2025
Estimated Study Completion Date : November 7, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD2693 dose 1
Participants will receive AZD2693 dose 1
 Drug: AZD2693
AZD2693 solution SC once per month
Experimental: AZD2693 dose 2
Participants will receive AZD2693 dose 2
 Drug: AZD2693
AZD2693 solution SC once per month
Placebo Comparator: Placebo
Participants in this arm will receive placebo
 Other: Placebo
Sodium chloride 0.9% solution SC once per month


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment [ Time Frame: after 52 weeks ]
    To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks


Secondary Outcome Measures :
  1. Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment [ Time Frame: after 52 weeks ]
    To assess the effects of AZD2693 versus placebo on histological fibrosis improvement

  2. Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment [ Time Frame: after 52 weeks ]
    To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS

  3. Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment [ Time Frame: after 52 weeks ]
    To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage


Other Outcome Measures:
  1. Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results [ Time Frame: 64 weeks ]
    Haematology, urinalysis, clinical chemistry and eGFR

  2. Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results [ Time Frame: 64 weeks ]
    Vital signs and electrocardiogram (ECG) assessments


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria :

Participants are eligible to be included in the study only if all the following criteria apply:

Age

  1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.

    Type of Participant and Disease Characteristics

  2. Participants who are carriers for the PNPLA3 rs738409 148M risk allele.

  3. Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:

    1. Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
    1. Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Key Exclusion Criteria :

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

  1. Liver disease of other aetiologies (eg, alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease)
  2. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
  3. Historical persistent or pre-existing renal disease marked by eGFR < 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
  4. Confirmed platelet count outside the normal range at the screening visit.

  5. Any of the following confirmed at the screening visit:

    1. ALT > 5.0 × ULN
    2. TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN)
    3. INR > 1.3
    4. ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05809934


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
AstraZeneca K.K.
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05809934    
Other Study ID Numbers: D7830C00004
2022-001629-65 ( EudraCT Number )
First Posted: April 12, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Nonalcoholic Steatohepatitis
NASH
fatty liver disease
Non alcoholic fatty liver
 liver fibrosis
PNPLA3 148M Risk Allele
Non Cirrhotic
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases