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

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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).

Key facts

Study ID

NCT05006885

Run by

Altimmune, Inc.

People needed

95

Starts

2021-09-30

Expected to finish

2022-08-17

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (greater than or equal to BMI 28.0
• 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

You may not qualify if…

• Women who are pregnant or breastfeeding
• Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
• History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Where it is running

• Headlands Research Scottsdale — Scottsdale, Arizona, United States
• QLMC — Tucson, Arizona, United States
• Catalina Research Institute — Montclair, California, United States
• Clinical Trials Research — Sacramento, California, United States
• Panax Clinical Research — Miami Lakes, Florida, United States
• Covenant Research and Clinics — Sarasota, Florida, United States
• Headlands Research Sarasota — Sarasota, Florida, United States
• Wake Research CRCN — Las Vegas, Nevada, United States
• Accelemed Research Institute — Austin, Texas, United States
• Pinnacle Research — Austin, Texas, United States
• South Texas Research Institute — Brownsville, Texas, United States
• South Texas Research Institute — Edinburg, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• Pinnacle Research — San Antonio, Texas, United States
• Cognitive Clinical Trials — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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