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
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
3 other identifiers
interventional
220
22 countries
164
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedOctober 28, 2025
October 1, 2025
2.3 years
February 23, 2023
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
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
after 52 weeks
Secondary Outcomes (3)
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
after 52 weeks
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
after 52 weeks
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
after 52 weeks
Other Outcomes (2)
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results
64 weeks
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results
64 weeks
Study Arms (3)
AZD2693 dose 1
EXPERIMENTALParticipants will receive AZD2693 dose 1
AZD2693 dose 2
EXPERIMENTALParticipants will receive AZD2693 dose 2
Placebo
PLACEBO COMPARATORParticipants in this arm will receive placebo
Interventions
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all the following criteria apply:
- Age
- Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
- 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:
- Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
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- Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- 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)
- History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
- 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).
- Confirmed platelet count outside the normal range at the screening visit.
- Any of the following confirmed at the screening visit:
- ALT \> 5.0 × ULN
- TBL \> 1.5 mg/dL (TBL \> 1.5 mg/dL is allowed if conjugated bilirubin is \< 1.5 × ULN)
- INR \> 1.3
- ALP \> 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (164)
Research Site
Chandler, Arizona, 85224, United States
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Peoria, Arizona, 85381, United States
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Surprise, Arizona, 85378, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85715, United States
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Gardena, California, 90247, United States
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La Mesa, California, 91942, United States
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Lancaster, California, 93534, United States
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Los Angeles, California, 90057, United States
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Montclair, California, 91763, United States
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Orange, California, 92868, United States
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Rialto, California, 92377, United States
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Santa Ana, California, 92704, United States
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Boca Raton, Florida, 33434, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32216, United States
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Port Orange, Florida, 32127, United States
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Winter Park, Florida, 32792, United States
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Marietta, Georgia, 30060, United States
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Topeka, Kansas, 66606, United States
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Detroit, Michigan, 48202, United States
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Las Vegas, Nevada, 89101, United States
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Westlake, Ohio, 44145, United States
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Chickasha, Oklahoma, 73018, United States
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Hershey, Pennsylvania, 17033, United States
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Summerville, South Carolina, 29485, United States
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Cordova, Tennessee, 38018, United States
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Austin, Texas, 78757, United States
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Brownsville, Texas, 78520, United States
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Denison, Texas, 75020, United States
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Edinburg, Texas, 78539, United States
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Houston, Texas, 77030, United States
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Red Oak, Texas, 75154, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77479, United States
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Richmond, Virginia, 23249, United States
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Seattle, Washington, 98105, United States
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CABA, C1119ACN, Argentina
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CABA, C1426, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Córdoba, X5000EPU, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, B7600GNY, Argentina
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San Juan Bautista, 1888, Argentina
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Botucatu, 18618-687, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 90035-903, Brazil
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Salvador, 40110-160, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 05403-000, Brazil
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Santiago, 7620157, Chile
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Santiago, 8380456, Chile
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Santiago, Chile
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Valdivia, 5110683, Chile
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Baotou, 014010, China
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Beijing, 100057, China
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Beijing, 100069, China
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Chengdu, 610072, China
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Fuzhou, 350005, China
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Guangzhou, 510515, China
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Hangzhou, 310003, China
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Liaocheng, 252000, China
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Nanchang, 330000, China
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Qingdao, 266011, China
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Shanghai, 200025, China
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Shanghai, 200080, China
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Shanghai, 200092, China
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Shenyang, 110004, China
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Taiyuan, 030001, China
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Wenzhou, 325000, China
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Xi'an, 710061, China
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Xuzhou, 221000, China
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Zhenjiang, 212021, China
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Cartagena, 130013, Colombia
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Konstanz, 78464, Germany
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Magdeburg, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Hong Kong, 999077, Hong Kong
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Shatin, Hong Kong
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Hyderabad, 500072, India
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Jaipur, 302001, India
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Jaipur, 302018, India
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Punjab, 160062, India
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Surat, 395009, India
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Milan, 20122, Italy
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Palermo, 90127, Italy
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Roma, 00128, Italy
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Rome, 00168, Italy
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Torino, 10126, Italy
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Bunkyō City, 113-8655, Japan
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Fukui-shi, 918-8503, Japan
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Fukuoka, 810-0065, Japan
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Gifu, 500-8513, Japan
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Kagoshima, 890-8520, Japan
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Kawasaki-shi, 215-0026, Japan
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Kobe, 650-0017, Japan
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Kumamoto, 860-8556, Japan
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Kure-shi, 737-0023, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 602-8566, Japan
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Minatoku, 105-8470, Japan
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Nagoya, 460-0001, Japan
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Okayama, 700-8505, Japan
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Omura-shi, 856-8562, Japan
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Osaka, 545-8586, Japan
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Ōita, 870-0837, Japan
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Saga, 849-8501, Japan
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Shinjuku-ku, 160-0023, Japan
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Shinjuku-ku, 160-8582, Japan
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Shinjuku-ku, 162-8655, Japan
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Takasaki-shi, 370-0829, Japan
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Tsu, 514-8507, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 245-8575, Japan
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Kota Kinabalu, 88586, Malaysia
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Pulau Pinang, 10450, Malaysia
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Seremban, 70300, Malaysia
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Acapulco, 39670, Mexico
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Guadalajara, 44340, Mexico
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Mexico City, 03330, Mexico
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Mexico City, 06700, Mexico
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Torreón, 27000, Mexico
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Veracruz, 91851, Mexico
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Xalapa, 91020, Mexico
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Chorrillos, Lima 9, Peru
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Lima, 15023, Peru
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Lima, 15036, Peru
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Lima, 15046, Peru
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Cebu, 6000, Philippines
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Puerto Princesa City, 5300, Philippines
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Roxas City, 5800, Philippines
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San Fernando City, 2000, Philippines
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Singapore, 119074, Singapore
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Singapore, 169608, Singapore
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Singapore, 308433, Singapore
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Junggu, 41944, South Korea
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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A Coruña, 15006, Spain
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Almería, 04009, Spain
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Lleida, 25198, Spain
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Málaga, 29010, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 80756, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Adana, 01060, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Eskişehir, 26480, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Rize, 530020, Turkey (Türkiye)
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
April 12, 2023
Study Start
March 15, 2023
Primary Completion
July 14, 2025
Study Completion
September 29, 2025
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.