Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)

What Was Tested

In this phase 1 trial, researchers set out to test Pemvidutide for fatty liver & elevated liver enzymes.

This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity 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.

More on the Plan

This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105.

It is designed to allow for an additional 12 weeks of treatment in order to assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).

Who Took Part

The registry lists 64 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 to participate in this extension study, signed prior to the performance of any study procedures. Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105. Women who are not pregnant or breastfeeding.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: meets any of the exclusion criteria in study alt-801-105 at the time of study entry; development of any of the following conditions at any time during study alt-801-105:; type 1 dm and/or insulin-dependent type 2 diabetes mellitus (t2dm), or uncontrolled t2dm requiring rescue therapy in study alt-801-105.

How the Study Was Run

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

Because people in this Pemvidutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2022-03-09 with completion listed for 2022-10-31.

It ran at 13 sites in United States (13).

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 64 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.