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

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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).

Key facts

Study ID

NCT05292911

Run by

Altimmune, Inc.

People needed

64

Starts

2022-03-09

Expected to finish

2022-10-31

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 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

You may not qualify if…

• 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:
• Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
• History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Where it is running

• 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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