Back to resultsA Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis (FORTUNA)
Primary Purpose
Nonalcoholic Steatohepatitis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2693
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring Nonalcoholic Steatohepatitis, NASH, fatty liver disease, Non alcoholic fatty liver, liver fibrosis, PNPLA3 148M Risk Allele, Non Cirrhotic
Eligibility Criteria
Key Inclusion Criteria : 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). 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 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)
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AZD2693 dose 1
AZD2693 dose 2
Placebo
Arm Description
Participants will receive AZD2693 dose 1
Participants will receive AZD2693 dose 2
Participants in this arm will receive placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
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
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
To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage
Full Information
NCT ID
NCT05809934
First Posted
February 23, 2023
Last Updated
September 28, 2023
Sponsor
AstraZeneca
Collaborators
AstraZeneca K.K.
1. Study Identification
Unique Protocol Identification Number
NCT05809934
Brief Title
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Acronym
FORTUNA
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
November 7, 2025 (Anticipated)
Study Completion Date
November 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
AstraZeneca K.K.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
Keywords
Nonalcoholic Steatohepatitis, NASH, fatty liver disease, Non alcoholic fatty liver, liver fibrosis, PNPLA3 148M Risk Allele, Non Cirrhotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AZD2693 dose 1
Arm Type
Experimental
Arm Description
Participants will receive AZD2693 dose 1
Arm Title
AZD2693 dose 2
Arm Type
Experimental
Arm Description
Participants will receive AZD2693 dose 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive placebo
Intervention Type
Drug
Intervention Name(s)
AZD2693
Intervention Description
AZD2693 solution SC once per month
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride 0.9% solution SC once per month
Primary Outcome Measure Information:
Title
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
Description
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
Time Frame
after 52 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
Description
To assess the effects of AZD2693 versus placebo on histological fibrosis improvement
Time Frame
after 52 weeks
Title
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
Description
To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS
Time Frame
after 52 weeks
Title
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
Description
To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage
Time Frame
after 52 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results
Description
Haematology, urinalysis, clinical chemistry and eGFR
Time Frame
64 weeks
Title
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results
Description
Vital signs and electrocardiogram (ECG) assessments
Time Frame
64 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria :
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).
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85378
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chickasha
State/Province
Oklahoma
ZIP/Postal Code
73018
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1426
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5000EPU
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5014PQC
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5016
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
40110-160
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
La Serena
ZIP/Postal Code
1781094
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7620157
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8330336
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Santiago
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valdivia
ZIP/Postal Code
5110683
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baotou
ZIP/Postal Code
014010
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100057
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610072
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300091
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhenjiang
ZIP/Postal Code
212021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Armenia
ZIP/Postal Code
630004
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cartagena
ZIP/Postal Code
130013
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Magdeburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Suspended
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shatin
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Belagavi
ZIP/Postal Code
590010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Gurugram
ZIP/Postal Code
122001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500072
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302018
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jodhpur
ZIP/Postal Code
342005
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Punjab
ZIP/Postal Code
160062
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rajkot
ZIP/Postal Code
360004
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Surat
ZIP/Postal Code
395009
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukui-shi
ZIP/Postal Code
918-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-0065
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-Shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gifu-shi
ZIP/Postal Code
500-8513
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kagoshima-shi
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
215-0026
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kure-shi
ZIP/Postal Code
737-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Meguro-ku
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagakute-shi
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ogaki-shi
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0837
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omura-shi
ZIP/Postal Code
856-8562
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saga-shi
ZIP/Postal Code
849-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
564-0013
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Takasaki-shi
ZIP/Postal Code
370-0829
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wako-shi
ZIP/Postal Code
351-0102
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
245-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jung-gu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kota Kinabalu
ZIP/Postal Code
88586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Acapulco
ZIP/Postal Code
39670
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
03310
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
03330
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mexico D.F.
ZIP/Postal Code
014080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tlalpan
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Xalapa
ZIP/Postal Code
91020
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chorrillos
ZIP/Postal Code
Lima 9
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Puerto Princesa City
ZIP/Postal Code
5300
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Roxas City
ZIP/Postal Code
5800
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Fernando
ZIP/Postal Code
2000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1250-189
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Almeria
ZIP/Postal Code
4009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rize
ZIP/Postal Code
530020
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
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