NCT05006885

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

A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	ALT-801	Injected subcutaneously (SC)
OTHER	Placebo	Injected subcutaneously (SC)

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2021-08-16
• Last updated: 2023-07-27

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study