Facilitated By

San Antonio Medical Foundation

A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study To Evaluate The Safety, Tolerability, And Efficacy Of NGM282 Administered For 12 Weeks In Patients With Histologically Confirmed Non-Alcoholic Steatohepatitis (NASH)

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

This is a multiple-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled, parallel-group study and/or an open-label single-blind cohort when administered for 12 weeks as a daily SC injection in patients with histologically confirmed NASH. Patients to be studied will have histologically confirmed NASH as defined by the NIH NASH Clinical Research Network and determined by a qualified site pathologist. Historical biopsy results within 6 months of Screening for the double-blind cohort or within 12 months of Screening for the single-blind cohort, may be used for inclusion into the study; otherwise, a liver biopsy must be obtained for assessment. Patients must have a nonalcoholic fatty liver disease (NAFLD) activity score (NAS) of at least 4, with 1 point in each of the three components, along with the presence of fibrosis. Patients with cirrhosis will be excluded from this study.

Collaborative Project
Clinical Care
Infectious Disease
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