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
40 participants
INTERVENTIONAL
2021-09-15
2022-05-15
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
OTHER
NONE
Study Groups
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Part 1 Metformin and Atorvastatin with and without Pemvidutide
In Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8.
In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg.
Pemvidutide
Injected subcutaneously (SC)
Metformin
Taken by mouth (PO)
Atorvastatin
Taken by mouth (PO)
Part 2 Warfarin and Digoxin with and without Pemvidutide
In Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8.
In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36.
Pemvidutide
Injected subcutaneously (SC)
Warfarin
Taken by mouth (PO)
Digoxin
Taken by mouth (PO)
Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide
In Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15.
In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43.
Pemvidutide
Injected subcutaneously (SC)
Ethinylestradiol and Levonorgestrel
Taken by mouth (PO)
Interventions
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Pemvidutide
Injected subcutaneously (SC)
Metformin
Taken by mouth (PO)
Atorvastatin
Taken by mouth (PO)
Warfarin
Taken by mouth (PO)
Digoxin
Taken by mouth (PO)
Ethinylestradiol and Levonorgestrel
Taken by mouth (PO)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 28.0- 40.0 kg/m2
* Able and willing to provide written informed consent prior to entry into the study
Exclusion Criteria
* History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
* History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
18 Years
55 Years
ALL
Yes
Sponsors
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Altimmune, Inc.
INDUSTRY
Responsible Party
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Locations
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CMAX Clinical Research
Adelaide, South Australia, Australia
Nucleus Network
Brisbane, , Australia
Countries
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Other Identifiers
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Pemvidutide
Identifier Type: OTHER
Identifier Source: secondary_id
ALT-801
Identifier Type: OTHER
Identifier Source: secondary_id
ALT-801-103
Identifier Type: -
Identifier Source: org_study_id
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