The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Headlands Research Scottsdale
Scottsdale, Arizona, United States
QLMC
Tucson, Arizona, United States
Catalina Research Institute
Montclair, California, United States
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Number of participants with 1 or more TEAEs up to Day 110
Time frame: Up to Day 110
Change from baseline in liver fat fraction by MRI-PDFF
Change in liver fat fraction by MRI-PDFF from Baseline to Day 85
Time frame: Baseline and Day 85
Change from baseline in body weight
Change in body weight from Baseline to Day 85
Time frame: Baseline and Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85
Time frame: Baseline and Day 85
Change from baseline in hemoglobin A1c
Change in hemoglobin A1c from Baseline to Day 85
Time frame: Baseline and Day 85
Change from baseline in fibrosis markers (Pro-C3)
Change in fibrosis markers (Pro-C3) from Baseline to Day 85
Time frame: Baseline and Day 85
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