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

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

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).

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: ALT-801; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Montclair, California, United States, 91763
      • Catalina Research Institute
    • Sacramento, California, United States, 95648
      • Clinical Trials Research
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • Sarasota, Florida, United States, 34243
      • Headlands Research Sarasota
    • Sarasota, Florida, United States, 34240
      • Covenant Research and Clinics
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Wake Research CRCN
  • Texas
    • Austin, Texas, United States, 78745
      • Accelemed Research Institute
    • Austin, Texas, United States, 78757
      • Pinnacle Research
    • Brownsville, Texas, United States, 78520
      • South Texas Research Institute
    • Edinburg, Texas, United States, 78539
      • South Texas Research Institute
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78229
      • Pinnacle Research
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Cognitive Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALT-801 Dose Level 1; Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Experimental: ALT-801 Dose Level 2; Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Experimental: ALT-801 Dose Level 3; Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Placebo Comparator: Placebo; Administered once a week for 12 weeks	Other: Placebo; Injected subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in liver fat fraction by MRI-PDFF	Change in MRI-PDFF	Baseline to Day 85
Change from baseline in body weight	Change in body weight	Baseline to Day 85
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
Change from baseline in hemoglobin A1c	Change in hemoglobin A1c	Baseline to Day 85
Change from baseline in fibrosis markers (Pro-C3)	Change in fibrosis markers (Pro-C3)	Baseline to Day 85

Collaborators and Investigators

• Sponsor: Altimmune, Inc.
• Investigators: Study Director: Sarah K Browne, MD, Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Overweight; Obese
• Additional Relevant MeSH Terms: Digestive System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Liver Diseases; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ALT-801-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No