ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

What Was Tested

This registered phase 1 trial tested Pemvidutide.

It had four arms (groups): ALT-801 (Part 1) (experimental), Placebo (Part 1) (placebo comparator), ALT-801 (Part 2) (experimental) and Placebo (Part 2) (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This study had 2 parts.

Each participant enrolled in only one part.

Who Took Part

The registry lists 100 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female healthy volunteers, age 18 to 60 years, inclusive. Overweight to obese (BMI 25.0 - 40.0 kg/m2). Non-smokers or ex-smokers (must have ceased smoking \> 1 months prior to screening visit). Ability and willingness to attend the necessary visits to the study center. Written informed consent signed prior to entry into the study.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: women who are pregnant or breastfeeding; history of pancreatitis; history of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions:.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Pemvidutide group and the comparison group should start out alike.

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

As a double-blind Pemvidutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2020-11-10 with completion listed for 2021-10-29.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42). Change in body weight (time frame: Baseline to Week 6).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pemvidutide in 100 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.