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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 overweight and obese subjects with non-alcoholic fatty liver disease (NAFLD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Altimmune, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry

• Body mass index (BMI) < 23 kg/m2

• Development of any of the following conditions at any time during Study ALT-801-105:

1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105

2. History of pancreatitis or hypersensitivity reaction to GLP-1 analogues