A Phase 1 interventional study of Pemvidutide and Metformin in NASH - Nonalcoholic Steatohepatitis, sponsored by Altimmune, Inc.. Completed at 2 sites in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Altimmune, Inc. · Phase 1, Interventional, and Other
This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of pemvidutide on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (COC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without pemvidutide administration and the second is with pemvidutide at steady state.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Altimmune, Inc. is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 4 (31%) have results posted.
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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.
Drug: Pemvidutide · Drug: Metformin · Drug: Atorvastatin
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.
Drug: Pemvidutide · Drug: Warfarin · Drug: Digoxin
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.
Drug: Pemvidutide · Drug: Ethinylestradiol and Levonorgestrel
Injected subcutaneously (SC)
Also known as: ALT-801
Taken by mouth (PO)
Taken by mouth (PO)
Taken by mouth (PO)
Taken by mouth (PO)
Taken by mouth (PO)
Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
Time frame: Baseline and Day 36
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
Time frame: Baseline and Day 43
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Time frame: Day 36
Cmax and Tmax of ethinylestradiol and levonorgestrel
Time frame: Day 43
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 77
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Altimmune, Inc.