Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
NCT ID: NCT05292911
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
64 participants
INTERVENTIONAL
2022-03-09
2022-10-31
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
* 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
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
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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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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Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Georges B, Roberts MS, Harris MS. Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. JHEP Rep. 2025 Jun 18;7(11):101483. doi: 10.1016/j.jhepr.2025.101483. eCollection 2025 Nov.
Other Identifiers
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ALT-801-106
Identifier Type: -
Identifier Source: org_study_id
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