A Study in Participants With Non-cirrhotic NASH With Fibrosis
NCT ID: NCT05638737
Last Updated: 2025-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2022-10-26
2024-04-04
Brief Summary
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Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.
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Detailed Description
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During screening, the participants will be checked for eligibility and enrolled in the study. Following a 8-week screening period, approximately 90 participants will be randomized in a 1:1 ratio to once daily dosing of AZD4831 or placebo. All participants will be treated once daily with AZD4831 or placebo for 12 weeks. The safety, tolerability, and pharmacodynamics will be evaluated at 12 weeks. This is the first clinical study to test AZD4831 in participants with non-cirrhotic NASH with fibrosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD4831
AZD4831
AZD4831
AZD4831
Placebo
Placebo
Placebo
Placebo
Interventions
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AZD4831
AZD4831
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosed by liver biopsy (within 12 months prior screening, participants without historical biopsy should be willing to undergo a liver biopsy at screening) fulfilling all of the following criteria:
* NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation and ballooning
* Presence of fibrosis F1, F2-F3
3. One increased serum ALT measurement (ALT \> ULN) at screening, and historical local serum ALT level (\> ULN \[41 U/L for men and 31 U/L for women\] but \< 300 U/L) on ≥ 1 occasion in the 6 months prior to screening.
Exclusion Criteria
2. History of excessive alcohol consumption, defined as an average weekly intake of \> 21 drinks/week for males or \> 14 drinks/week for females. One drink is equivalent to 14 g alcohol.
3. Recent (within 3 months of randomization) use of drugs approved for weight loss (eg, orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label.
4. High dose vitamin E (\> 400 IU) unless on a stable dose within 6 months of screening.
5. Recent (within 6 months of screening) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines).
6. Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.
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
Research Site
Tucson, Arizona, United States
Research Site
Chula Vista, California, United States
Research Site
Montclair, California, United States
Research Site
Orange, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Stanford, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Lakeland, Florida, United States
Research Site
Lakeland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Yonkers, New York, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
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CABA, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Pilar, , Argentina
Research Site
Ramos Mejía, , Argentina
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Aarhus N, , Denmark
Research Site
Esbjerg, , Denmark
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København NV, , Denmark
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København Ø, , Denmark
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Køge, , Denmark
Research Site
Catania, , Italy
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Foggia, , Italy
Research Site
Milan, , Italy
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Milan, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
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Rozzano, , Italy
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San Giovanni Rotondo, , Italy
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Torino, , Italy
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Boca del Rio, , Mexico
Research Site
Cuauhtémoc, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Mexico City, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Gjøvik, , Norway
Research Site
Grålum, , Norway
Research Site
Lørenskog, , Norway
Research Site
Oslo, , Norway
Research Site
Tromsø, , Norway
Research Site
Lisbon, , Portugal
Research Site
A Coruña, , Spain
Research Site
Lleida, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Pozuelo de Alarcón, , Spain
Research Site
Santander, , Spain
Research Site
Valencia, , Spain
Research Site
Linköping, , Sweden
Research Site
Uppsala, , Sweden
Countries
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References
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Armisen J, Flor A, Eriksson J, Nelander K, Bhattacharya CS, Sunnaker M, Carter D, Trebski M, Gardmark E, Aurell M, Whatling C, Challis B, Vespasiani-Gentilucci U; COSMOS Investigators. A Phase 2a Trial of Myeloperoxidase Inhibitor Mitiperstat in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis. Liver Int. 2025 Nov;45(11):e70406. doi: 10.1111/liv.70406.
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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D6581C00001
Identifier Type: -
Identifier Source: org_study_id
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