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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292911
• Other study ID #: ALT-801-106
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105

2. 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

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 one or more TEAEs	Up to Day 110
Secondary	Change from baseline in liver fat fraction by MRI-PDFF	Change in MRI-PDFF	Baseline to Day 85
Secondary	Change from baseline in body weight	Change in body weight	Baseline to Day 85
Secondary	Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)	Change in lipid metabolism (TC, HDL, LDL)	Baseline to Day 85
Secondary	Change from baseline in hemoglobin A1c	Change in hemoglobin A1c	Baseline to Day 85
Secondary	Change from baseline in fibrosis markers (Pro-C3)	Change in fibrosis markers (Pro-C3)	Baseline to Day 85