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

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

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).

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

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

• 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