A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT ID: NCT05809934
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2023-03-15
2025-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD2693 dose 1
Participants will receive AZD2693 dose 1
AZD2693
AZD2693 solution SC once per month
AZD2693 dose 2
Participants will receive AZD2693 dose 2
AZD2693
AZD2693 solution SC once per month
Placebo
Participants in this arm will receive placebo
Placebo
Sodium chloride 0.9% solution SC once per month
Interventions
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AZD2693
AZD2693 solution SC once per month
Placebo
Sodium chloride 0.9% solution SC once per month
Eligibility Criteria
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Inclusion Criteria
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).
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1. Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
Exclusion Criteria
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)
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chandler, Arizona, United States
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Peoria, Arizona, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Gardena, California, United States
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La Mesa, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Orange, California, United States
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Rialto, California, United States
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Santa Ana, California, United States
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Boca Raton, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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Winter Park, Florida, United States
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Marietta, Georgia, United States
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Topeka, Kansas, United States
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Detroit, Michigan, United States
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Las Vegas, Nevada, United States
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Westlake, Ohio, United States
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Chickasha, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Summerville, South Carolina, United States
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Cordova, Tennessee, United States
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Austin, Texas, United States
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Brownsville, Texas, United States
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Denison, Texas, United States
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Edinburg, Texas, United States
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Houston, Texas, United States
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Red Oak, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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CABA, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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Mar del Plata, , Argentina
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San Juan Bautista, , Argentina
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Botucatu, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Baotou, , China
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Beijing, , China
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Beijing, , China
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Chengdu, , China
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Fuzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Liaocheng, , China
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Nanchang, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Taiyuan, , China
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Wenzhou, , China
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Xi'an, , China
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Xuzhou, , China
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Zhenjiang, , China
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Cartagena, , Colombia
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Konstanz, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Münster, , Germany
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Hyderabad, , India
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Jaipur, , India
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Jaipur, , India
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Punjab, , India
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Surat, , India
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Milan, , Italy
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Palermo, , Italy
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Roma, , Italy
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Rome, , Italy
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Torino, , Italy
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Bunkyō City, , Japan
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Fukui-shi, , Japan
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Fukuoka, , Japan
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Gifu, , Japan
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Kagoshima, , Japan
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Kawasaki-shi, , Japan
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Kobe, , Japan
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Kumamoto, , Japan
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Kure-shi, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Minatoku, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Omura-shi, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Saga, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Takasaki-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Pulau Pinang, , Malaysia
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Seremban, , Malaysia
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Acapulco, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Torreón, , Mexico
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Veracruz, , Mexico
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Xalapa, , Mexico
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Chorrillos, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Cebu, , Philippines
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Puerto Princesa City, , Philippines
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Roxas City, , Philippines
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San Fernando City, , Philippines
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Junggu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Almería, , Spain
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Lleida, , Spain
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Málaga, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Adana, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Rize, , Turkey (Türkiye)
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2023-509704-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-001629-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7830C00004
Identifier Type: -
Identifier Source: org_study_id
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