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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and tolerability of 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 signed prior to the performance of any study procedures

• Male or female volunteers, age 18 to 65 years, inclusive

• Overweight to obese (BMI 28.0 - 40.0 kg/m2)

• Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%

• If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 10% or fasting blood glucose ≥ 200 mg/dL (11.1 mmol/L)

• History of pancreatitis or hypersensitivity reaction to GLP-1 analogues