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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
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
Time frame: after 52 weeks
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
Time frame: after 52 weeks
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
Time frame: after 52 weeks
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
Time frame: after 52 weeks
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Research Site
Chandler, Arizona, United States
Research Site
Peoria, Arizona, United States
Research Site
Surprise, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Gardena, California, United States
Research Site
La Mesa, California, United States
Research Site
Lancaster, California, United States
Research Site
Los Angeles, California, United States
Research Site
Montclair, California, United States
...and 154 more locations