This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Catalina Research Institute
Montclair, California, United States
Clinical Trials Research
Sacramento, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Number of participants with one or more TEAEs
Time frame: Up to Day 110
Change from baseline in liver fat fraction by MRI-PDFF
Change in MRI-PDFF
Time frame: Baseline to Day 85
Change from baseline in body weight
Change in body weight
Time frame: Baseline to Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Change in lipid metabolism (TC, HDL, LDL)
Time frame: Baseline to Day 85
Change from baseline in hemoglobin A1c
Change in hemoglobin A1c
Time frame: Baseline to Day 85
Change from baseline in fibrosis markers (Pro-C3)
Change in fibrosis markers (Pro-C3)
Time frame: Baseline to Day 85
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Covenant Research and Clinics
Sarasota, Florida, United States
Headlands Research Sarasota
Sarasota, Florida, United States
Wake Research CRCN
Las Vegas, Nevada, United States
Accelemed Research Institute
Austin, Texas, United States
Pinnacle Research
Austin, Texas, United States
South Texas Research Institute
Brownsville, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
...and 3 more locations