ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

What Was Tested

This registered phase 1 trial tested Pemvidutide for fatty liver & elevated liver enzymes.

The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

Administered once a week for 12 weeks.

Administered once a week for 12 weeks.

Administered once a week for 12 weeks.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 95 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent signed prior to the performance of any study procedures. Male or female volunteers, age 18 to 65 years, inclusive. Overweight to obese (greater than or equal to BMI 28.0.

The full record lists 5 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

Design: randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Pemvidutide.

Those kept unaware of assignments: participant and investigator.

It started in 2021-09-30 with completion listed for 2022-08-17.

It ran at 15 sites in United States (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Day 110).

It also tracked 5 secondary outcomes, for example Change from baseline in liver fat fraction by MRI-PDFF, Change from baseline in body weight, Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions), Change from baseline in hemoglobin A1c and Change from baseline in fibrosis markers (Pro-C3).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pemvidutide in 95 people with fatty liver & elevated liver enzymes.

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

More context: the Pemvidutide compound page, Fatty liver & elevated liver enzymes research.