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Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04972396
Enrollment
40
Registered
2021-07-22
Start date
2021-09-15
Completion date
2022-05-15
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

Brief summary

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.

Interventions

DRUGWarfarin

Taken by mouth (PO)

DRUGDigoxin

Taken by mouth (PO)

DRUGEthinylestradiol and Levonorgestrel

Taken by mouth (PO)

DRUGPemvidutide

Injected subcutaneously (SC)

DRUGMetformin

Taken by mouth (PO)

DRUGAtorvastatin

Taken by mouth (PO)

Sponsors

Altimmune, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female healthy volunteers, age 18 to 55 years, inclusive * 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

* Women who are pregnant or breastfeeding * 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

Design outcomes

Primary

MeasureTime frame
Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801Baseline and Day 36
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801Baseline and Day 43

Secondary

MeasureTime frame
Cmax and Tmax of ethinylestradiol and levonorgestrelDay 43
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)Up to Day 77
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxinDay 36

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026