Skip to main content
OpenTrials
Completed

NCT Number: NCT04972396

Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemvidutide

Drug

Injected subcutaneously (SC)

Other names: ALT-801

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)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin

    Time frame: Day 36

  2. Cmax and Tmax of ethinylestradiol and levonorgestrel

    Time frame: Day 43

  3. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 77

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.