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

Phase 1 Completed 95 enrolled Altimmune, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start: 2021-09-30
Primary completion: 2022-08-17
Completion: 2022-08-17

Outcome

Met primary endpoint

paper significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo. PMID 39002641 ↗

paper p <0.001 vs. placebo, all treatment groups PMID 39002641 ↗

Publications

Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS. Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jan;82(1):7-17. doi: 10.1016/j.jhep.2024.07.006. Epub 2024 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALT-801	Protein / enzyme biologic	1.2 mg	Subcutaneous
Subject	ALT-801	Protein / enzyme biologic	1.8 mg	Subcutaneous
Subject	ALT-801	Protein / enzyme biologic	2.4 mg	Subcutaneous