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

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

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).

Study Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Headlands Research Scottsdale
    • Tucson, Arizona, United States, 85712
      • QLMC
  • 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 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

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 1 or more TEAEs up to Day 110	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 liver fat fraction by MRI-PDFF from Baseline to Day 85	Baseline and Day 85
Change from baseline in body weight	Change in body weight from Baseline to Day 85	Baseline and Day 85
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
Change from baseline in hemoglobin A1c	Change in hemoglobin A1c from Baseline to Day 85	Baseline and Day 85
Change from baseline in fibrosis markers (Pro-C3)	Change in fibrosis markers (Pro-C3) from Baseline to Day 85	Baseline and 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): September 30, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

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

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-801-105

Drug and device information, study documents

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