ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver… (NCT05006885) | Clinical Trial Compass
CompletedPhase 1
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
United States95 participantsStarted 2021-09-30
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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 (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
Exclusion Criteria:
* 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
What they're measuring
1
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)