ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
- Registration Number
- NCT05006885
- Lead Sponsor
- Altimmune, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Written informed consent signed prior to the performance of any study procedures
- Male or female volunteers, age 18 to 65 years, inclusive
- Overweight to obese (greater than or equal to BMI 28.0
- Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
- If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy
- Women who are pregnant or breastfeeding
- Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
- History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALT-801 Dose Level 1 ALT-801 Administered once a week for 12 weeks ALT-801 Dose Level 2 ALT-801 Administered once a week for 12 weeks ALT-801 Dose Level 3 ALT-801 Administered once a week for 12 weeks Placebo Placebo Administered once a week for 12 weeks
- Primary Outcome Measures
Name Time Method The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Up to Day 110 Number of participants with 1 or more TEAEs up to Day 110
- Secondary Outcome Measures
Name Time Method Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions) Baseline and Day 85 Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85
Change from baseline in hemoglobin A1c Baseline and Day 85 Change in hemoglobin A1c from Baseline to Day 85
Change from baseline in liver fat fraction by MRI-PDFF Baseline and Day 85 Change in liver fat fraction by MRI-PDFF from Baseline to Day 85
Change from baseline in body weight Baseline and Day 85 Change in body weight from Baseline to Day 85
Change from baseline in fibrosis markers (Pro-C3) Baseline and Day 85 Change in fibrosis markers (Pro-C3) from Baseline to Day 85
Trial Locations
- Locations (13)
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Pinnacle Research
🇺🇸San Antonio, Texas, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
QLMC
🇺🇸Tucson, Arizona, United States
Accelemed Research Institute
🇺🇸Austin, Texas, United States
Covenant Research and Clinics
🇺🇸Sarasota, Florida, United States
Wake Research CRCN
🇺🇸Las Vegas, Nevada, United States
Headlands Research Scottsdale
🇺🇸Scottsdale, Arizona, United States
Cognitive Clinical Trials
🇺🇸Salt Lake City, Utah, United States
Headlands Research Sarasota
🇺🇸Sarasota, Florida, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
South Texas Research Institute
🇺🇸Edinburg, Texas, United States