Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Pemvidutide.

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 be conducted in 3 parts, as described below.

It had three arms (groups): Part 1 Metformin and Atorvastatin with and without Pemvidutide (experimental), Part 2 Warfarin and Digoxin with and without Pemvidutide (experimental) and Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide (experimental).

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: women who are pregnant or breastfeeding; history of pancreatitis or hypersensitivity reaction to glp-1 analogues.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Pemvidutide and who got the comparison, which limits bias.

The Pemvidutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Pemvidutide study: the participants and staff both knew the treatment.

It started in 2021-09-15 with completion listed for 2022-05-15.

It ran at 2 sites in Australia (2).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 3 secondary outcomes, for example Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin, Cmax and Tmax of ethinylestradiol and levonorgestrel and The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pemvidutide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pemvidutide compound page, all human trials.