A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
aldafermin
Placebo for aldafermin
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.
Time frame: 48 weeks
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NGM Clinical Study Site
Glendale, Arizona, United States
NGM Clinical Study Site 413
Tucson, Arizona, United States
NGM Clinical Study Site 415
Tucson, Arizona, United States
NGM Clinical Study Site
North Little Rock, Arkansas, United States
NGM Clinical Study Site
Fresno, California, United States
NGM Clinical Study Site
La Jolla, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Panorama City, California, United States
NGM Clinical Study Site
Rialto, California, United States
NGM Clinical Study Site
Boca Raton, Florida, United States
...and 39 more locations