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

Phase 1

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: ALT-801; Other: Placebo

• Registration Number: NCT05292911
• Lead Sponsor: Altimmune, Inc.

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-23
• Status Verified: 2022-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALT-801 Dose Level 3	ALT-801	Administered once a week for 12 weeks
Placebo	Placebo	Administered once a week for 12 weeks
ALT-801 Dose Level 1	ALT-801	Administered once a week for 12 weeks
ALT-801 Dose Level 2	ALT-801	Administered once a week for 12 weeks

Primary Outcome Measures

Name	Time	Method
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)	Up to Day 110	Number of participants with one or more TEAEs

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fibrosis markers (Pro-C3)	Baseline to Day 85	Change in fibrosis markers (Pro-C3)
Change from baseline in body weight	Baseline to Day 85	Change in body weight
Change from baseline in liver fat fraction by MRI-PDFF	Baseline to Day 85	Change in MRI-PDFF
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)	Baseline to Day 85	Change in lipid metabolism (TC, HDL, LDL)
Change from baseline in hemoglobin A1c	Baseline to Day 85	Change in hemoglobin A1c

Trial Locations

Locations (11)

Wake Research CRCN; 🇺🇸 Las Vegas, Nevada, United States

Panax Clinical Research; 🇺🇸 Miami Lakes, Florida, United States

Diagnostics Research Group; 🇺🇸 San Antonio, Texas, United States

Covenant Research and Clinics; 🇺🇸 Sarasota, Florida, United States

Pinnacle Research; 🇺🇸 San Antonio, Texas, United States

Cognitive Clinical Trials; 🇺🇸 Salt Lake City, Utah, United States

Catalina Research Institute; 🇺🇸 Montclair, California, United States

Clinical Trials Research; 🇺🇸 Sacramento, California, United States

Accelemed Research Institute; 🇺🇸 Austin, Texas, United States

South Texas Research Institute; 🇺🇸 Edinburg, Texas, United States

Headlands Research Sarasota; 🇺🇸 Sarasota, Florida, United States