DRUG
ALT-801
Injected subcutaneously (SC)
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
Status
Completed
Phase
Phase 1
Enrollment
95
Locations
15
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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).
Full 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.
Interventions
Treatment arms and agents.
OTHER
Placebo
Injected subcutaneously (SC)
Timeline
From registration to results.
First posted
Aug 16, 2021
Study start
Sep 30, 2021
Primary completion
Aug 17, 2022
Study completion
Aug 17, 2022
Results posted
Not reported
Registry updated
Jul 27, 2023
Outcomes
What the study measures.
Primary outcomes
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame · Up to Day 110
Number of participants with 1 or more TEAEs up to Day 110
Secondary outcomes
Change from baseline in liver fat fraction by MRI-PDFF
Time frame · Baseline and Day 85
Change in liver fat fraction by MRI-PDFF from Baseline to Day 85
Change from baseline in body weight
Time frame · Baseline and Day 85
Change in body weight from Baseline to Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Time frame · Baseline and Day 85
Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85
Change from baseline in hemoglobin A1c
Time frame · Baseline and Day 85
Change in hemoglobin A1c from Baseline to Day 85
Change from baseline in fibrosis markers (Pro-C3)
Time frame · Baseline and Day 85
Change in fibrosis markers (Pro-C3) from Baseline to Day 85
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 locations
15 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Headlands Research Scottsdale
Scottsdale, Arizona, United States
QLMC
Tucson, Arizona, United States
Catalina Research Institute
Montclair, California, United States
Clinical Trials Research
Sacramento, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
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
Diagnostics Research Group
San Antonio, Texas, United States
Pinnacle Research
San Antonio, Texas, United States
Cognitive Clinical Trials
Salt Lake City, Utah, United States
Publications
Results and literature.
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