ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT05006885
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
95 participants
INTERVENTIONAL
2021-09-30
2022-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALT-801 Dose Level 1
Administered once a week for 12 weeks
ALT-801
Injected subcutaneously (SC)
ALT-801 Dose Level 2
Administered once a week for 12 weeks
ALT-801
Injected subcutaneously (SC)
ALT-801 Dose Level 3
Administered once a week for 12 weeks
ALT-801
Injected subcutaneously (SC)
Placebo
Administered once a week for 12 weeks
Placebo
Injected subcutaneously (SC)
Interventions
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ALT-801
Injected subcutaneously (SC)
Placebo
Injected subcutaneously (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Altimmune, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah K Browne, MD
Role: STUDY_DIRECTOR
Altimmune, Inc.
Locations
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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
Countries
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References
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Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS. Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jan;82(1):7-17. doi: 10.1016/j.jhep.2024.07.006. Epub 2024 Jul 11.
Other Identifiers
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ALT-801-105
Identifier Type: -
Identifier Source: org_study_id
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