Status:
COMPLETED
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
Lead Sponsor:
Altimmune, Inc.
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 (N...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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:
- Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
- History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05292911
Start Date
March 9 2022
End Date
October 31 2022
Last Update
July 27 2023
Active Locations (13)
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1
Catalina Research Institute
Montclair, California, United States, 91763
2
Clinical Trials Research
Sacramento, California, United States, 95648
3
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
4
Covenant Research and Clinics
Sarasota, Florida, United States, 34240