Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

NCT04972396 · Completed

Last updated 2026-05-28

This clinical trial is testing how the experimental drug pemvidutide (ALT-801) affects the levels of metformin, atorvastatin, warfarin, and digoxin in the bloodstream of healthy volunteers.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) study

Participants 40 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2021-09 · est. completion 2022-05

Where 2 sites · Australia

What this study is testing ClinicalTrials.gov NCT04972396 ↗

Description as written by the study sponsor.

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.

Treatments tested

Pemvidutide also known as ALT-801 Drug

Injected subcutaneously (SC)
Metformin Drug

Taken by mouth (PO)
Atorvastatin Drug

Taken by mouth (PO)
Warfarin Drug

Taken by mouth (PO)
Digoxin Drug

Taken by mouth (PO)
Ethinylestradiol and Levonorgestrel Drug

Taken by mouth (PO)

Main thing measured	Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
Sponsor	Altimmune, Inc.
Conditions studied	NASH - Nonalcoholic Steatohepatitis
GLP-1 drugs	pemvidutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04972396 ↗