DRUG
ALT-801
Injected subcutaneously (SC)
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
Status
Completed
Phase
Phase 1
Enrollment
64
Locations
13
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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).
Full detailed description
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).
Interventions
Treatment arms and agents.
OTHER
Placebo
Injected subcutaneously (SC)
Timeline
From registration to results.
First posted
Mar 23, 2022
Study start
Mar 9, 2022
Primary completion
Oct 31, 2022
Study completion
Oct 31, 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 one or more TEAEs
Secondary outcomes
Change from baseline in liver fat fraction by MRI-PDFF
Time frame · Baseline to Day 85
Change in MRI-PDFF
Change from baseline in body weight
Time frame · Baseline to Day 85
Change in body weight
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Time frame · Baseline to Day 85
Change in lipid metabolism (TC, HDL, LDL)
Change from baseline in hemoglobin A1c
Time frame · Baseline to Day 85
Change in hemoglobin A1c
Change from baseline in fibrosis markers (Pro-C3)
Time frame · Baseline to Day 85
Change in fibrosis markers (Pro-C3)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent to participate in this extension study, signed prior to the performance of any study procedures * Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105 * Women who are not pregnant or breastfeeding Exclusion Criteria: * Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry * Development of any of the following conditions at any time during Study ALT-801-105: 1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105 2. History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
Study locations
13 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
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