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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006885
• Other study ID #: ALT-801-105
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2021
• Est. completion date: August 17, 2022

Study information

• Verified date: July 2023
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease
• Overweight

Intervention

Drug:
• ALT-801
Injected subcutaneously (SC)

Other:
• Placebo
Injected subcutaneously (SC)

Locations

Country	Name	City	State
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	Wake Research CRCN	Las Vegas	Nevada
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Catalina Research Institute	Montclair	California
United States	Clinical Trials Research	Sacramento	California
United States	Cognitive Clinical Trials	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	Pinnacle Research	San Antonio	Texas
United States	Covenant Research and Clinics	Sarasota	Florida
United States	Headlands Research Sarasota	Sarasota	Florida
United States	Headlands Research Scottsdale	Scottsdale	Arizona
United States	QLMC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)	Number of participants with 1 or more TEAEs up to Day 110	Up to Day 110
Secondary	Change from baseline in liver fat fraction by MRI-PDFF	Change in liver fat fraction by MRI-PDFF from Baseline to Day 85	Baseline and Day 85
Secondary	Change from baseline in body weight	Change in body weight from Baseline to Day 85	Baseline and Day 85
Secondary	Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)	Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85	Baseline and Day 85
Secondary	Change from baseline in hemoglobin A1c	Change in hemoglobin A1c from Baseline to Day 85	Baseline and Day 85
Secondary	Change from baseline in fibrosis markers (Pro-C3)	Change in fibrosis markers (Pro-C3) from Baseline to Day 85	Baseline and Day 85