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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

Tracking Information
First Submitted Date  ICMJE February 23, 2023
First Posted Date  ICMJE April 12, 2023
Last Update Posted Date April 12, 2024
Actual Study Start Date  ICMJE March 15, 2023
Estimated Primary Completion Date November 7, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2023)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2023)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2023)
  • 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 in participants who are carriers of the PNPLA3 risk allele
  • 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 NASH in participants who are carriers of the PNPLA3 risk allele
  • 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 in participant who are carriers of the PNPLA3 risk allele
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2023)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: AZD2693
    AZD2693 solution SC once per month
  • Other: Placebo
    Sodium chloride 0.9% solution SC once per month
Study Arms  ICMJE
  • Experimental: AZD2693 dose 1
    Participants will receive AZD2693 dose 1
    Intervention: Drug: AZD2693
  • Experimental: AZD2693 dose 2
    Participants will receive AZD2693 dose 2
    Intervention: Drug: AZD2693
  • Placebo Comparator: Placebo
    Participants in this arm will receive placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2023)
180
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2023)
232
Estimated Study Completion Date  ICMJE November 7, 2025
Estimated Primary Completion Date November 7, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Chile,   China,   Colombia,   Germany,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Peru,   Philippines,   Portugal,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05809934
Other Study ID Numbers  ICMJE D7830C00004
2022-001629-65 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AstraZeneca K.K.
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP