A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT ID: NCT05364931
Last Updated: 2025-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2022-07-14
2024-04-19
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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Cotadutide 300μg
Cotadutide
Cotadutide administered subcutaneously once daily
Placebo 300μg
Placebo
Placebo administered subcutaneously once daily
Cotadutide 600μg
Cotadutide
Cotadutide administered subcutaneously once daily
Placebo 600μg
Placebo
Placebo administered subcutaneously once daily
Interventions
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Cotadutide
Cotadutide administered subcutaneously once daily
Placebo
Placebo administered subcutaneously once daily
Eligibility Criteria
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Inclusion Criteria
2. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:
1. NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning
2. Presence of fibrosis stage F2 or F3
4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
Exclusion Criteria
2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).
3. Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening
4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.
6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator
8. Severely uncontrolled hypertension defined as SBP ≥ 180 mmHg or DBP ≥ 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Gilroy, California, United States
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Sacramento, California, United States
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Englewood, Colorado, United States
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Bradenton, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Winter Park, Florida, United States
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Munster, Indiana, United States
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Houma, Louisiana, United States
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Marrero, Louisiana, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Ann Arbor, Michigan, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Lawrence, New Jersey, United States
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Warren Township, New Jersey, United States
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Morehead City, North Carolina, United States
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Chattanooga, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Lewisville, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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CABA, , Argentina
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Heidelberg, , Australia
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Kogarah, , Australia
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Meadowbrook, , Australia
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Melbourne, , Australia
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Westmead, , Australia
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Vienna, , Austria
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Vienna, , Austria
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London, Ontario, Canada
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Terrebonne, Quebec, Canada
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Montpellier, , France
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Paris, , France
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Dresden, , Germany
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Konstanz, , Germany
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Athens, , Greece
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Ioannina, , Greece
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Haifa, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Catania, , Italy
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Foggia, , Italy
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Milan, , Italy
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Roma, , Italy
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Roma, , Italy
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Rozzano, , Italy
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San Giovanni Rotondo, , Italy
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Chiba, , Japan
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Fukui-shi, , Japan
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Gifu, , Japan
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Hiroshima, , Japan
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Kawasaki-shi, , Japan
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Kawasaki-shi, , Japan
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Kure-shi, , Japan
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Osaka, , Japan
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Saga, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Takasaki-shi, , Japan
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Toon-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Malacca, , Malaysia
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Seremban, , Malaysia
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Grafton, , New Zealand
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Plumstead, , South Africa
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Busan, , South Korea
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Gangwon-do, , South Korea
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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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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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Madrid, , Spain
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Málaga, , Spain
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Seville, , 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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Taipei, , 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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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Glasgow, , United Kingdom
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Ipswich, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Preston, , United Kingdom
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Rochdale, , United Kingdom
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Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2021-005484-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5671C00006
Identifier Type: -
Identifier Source: org_study_id
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