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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 17, 2022

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.

Interventions

  • Drug: ALT-801
    • Injected subcutaneously (SC)
  • Other: Placebo
    • Injected subcutaneously (SC)

Arms, Groups and Cohorts

  • Experimental: ALT-801 Dose Level 1
    • Administered once a week for 12 weeks
  • Experimental: ALT-801 Dose Level 2
    • Administered once a week for 12 weeks
  • Experimental: ALT-801 Dose Level 3
    • Administered once a week for 12 weeks
  • Placebo Comparator: Placebo
    • Administered once a week for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
    • Time Frame: Up to Day 110
    • Number of participants with 1 or more TEAEs up to Day 110

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Altimmune, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sarah K Browne, MD, Study Director, Altimmune, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.