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

Phase 1 Completed 64 enrolled Altimmune, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start: 2022-03-09
Primary completion: 2022-10-31
Completion: 2022-10-31

Outcome

Met primary endpoint

paper 2.4 mg groups respectively, vs. 14.0% for placebo (p <0.001 vs. placebo, all treatment groups) PMID 41113119 ↗

Publications

Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Georges B, Roberts MS, Harris MS. Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. JHEP Rep. 2025 Jun 18;7(11):101483. doi: 10.1016/j.jhepr.2025.101483. eCollection 2025 Nov.

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