Phase
Condition
Scar Tissue
Liver Disease
Treatment
AZD4831
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informedconsent.
- Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosedby liver biopsy (within 12 months prior screening, participants without historicalbiopsy should be willing to undergo a liver biopsy at screening) fulfilling all of thefollowing criteria:
- NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammationand ballooning
- Presence of fibrosis F1, F2-F3
- One increased serum ALT measurement (ALT > ULN) at screening, and historical localserum ALT level (> ULN [41 U/L for men and 31 U/L for women] but < 300 U/L) on ≥ 1occasion in the 6 months prior to screening.
Exclusion
Exclusion Criteria:
- Liver disease of other etiologies (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 excessive alcohol consumption, defined as an average weekly intake of > 21drinks/week for males or > 14 drinks/week for females. One drink is equivalent to 14 galcohol.
- Recent (within 3 months of randomization) use of drugs approved for weight loss (eg,orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), aswell as those drugs used off-label.
- High dose vitamin E (> 400 IU) unless on a stable dose within 6 months of screening.
- Recent (within 6 months of screening) use of therapies associated with development ofNAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-termuse of tetracyclines).
- Recent (within 6 months of screening) use of obeticholic acid or other therapy underinvestigation for NASH.
Study Design
Study Description
Connect with a study center
Research Site
Caba, C1056ABJ
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, 1280
ArgentinaSite Not Available
Research Site
Mar del Plata, 7600
ArgentinaSite Not Available
Research Site
Ramos Mejía, B1704ETD
ArgentinaSite Not Available
Research Site
Aarhus N, 8200
DenmarkSite Not Available
Research Site
Esbjerg, 6700
DenmarkSite Not Available
Research Site
Koge, 4600
DenmarkSite Not Available
Research Site
København NV, 2400
DenmarkSite Not Available
Research Site
Catania, 95100
ItalySite Not Available
Research Site
Foggia, 71100
ItalySite Not Available
Research Site
Milan, 20122
ItalySite Not Available
Research Site
Milano, 20132
ItalySite Not Available
Research Site
Roma, 00168
ItalySite Not Available
Research Site
Rome, 00168
ItalySite Not Available
Research Site
Rozzano, 20089
ItalySite Not Available
Research Site
San Giovanni Rotondo, 71013
ItalySite Not Available
Research Site
Torino, 10126
ItalySite Not Available
Research Site
Ciudad de Mexico, 06700
MexicoSite Not Available
Research Site
Guadalajara, 44340
MexicoSite Not Available
Research Site
Mexico City, 03330
MexicoSite Not Available
Research Site
Monterrey, 64000
MexicoSite Not Available
Research Site
México, 03300
MexicoSite Not Available
Research Site
Grålum, 1714
NorwaySite Not Available
Research Site
Lørenskog, N-1478
NorwaySite Not Available
Research Site
Oslo, 0456
NorwaySite Not Available
Research Site
Tromsø, N-9038
NorwaySite Not Available
Research Site
Lisboa, 1250-189
PortugalSite Not Available
Research Site
La Coruña, 15006
SpainSite Not Available
Research Site
Lérida, 25198
SpainSite Not Available
Research Site
Madrid, 28046
SpainSite Not Available
Research Site
Málaga, 29010
SpainSite Not Available
Research Site
Pozuelo de Alarcon, 28223
SpainSite Not Available
Research Site
Santander, 39008
SpainSite Not Available
Research Site
Valencia, 46014
SpainSite Not Available
Research Site
Linköping, 581 85
SwedenSite Not Available
Research Site
Uppsala, 751 85
SwedenSite Not Available
Research Site
Chandler, Arizona 85224
United StatesSite Not Available
Research Site
Tucson, Arizona 85712
United StatesSite Not Available
Research Site
Chula Vista, California 91911
United StatesSite Not Available
Research Site
Montclair, California 91763
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Redondo Beach, California 90277
United StatesSite Not Available
Research Site
Stanford, California 94305
United StatesSite Not Available
Research Site
Jacksonville, Florida 32256
United StatesSite Not Available
Research Site
Lakeland, Florida 33813
United StatesSite Not Available
Research Site
Miami, Florida 33135
United StatesSite Not Available
Research Site
Las Vegas, Nevada 89109
United StatesSite Not Available
Research Site
Yonkers, New York 10701
United StatesSite Not Available
Research Site
San Antonio, Texas 78229
United StatesSite Not Available
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