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Completed

NCT Number: NCT05006885

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

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).

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Headlands Research Scottsdale, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALT-801

Drug

Injected subcutaneously (SC)

Other names: Pemvidutide

Placebo

Other

Injected subcutaneously (SC)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change from baseline in body weight

    Time frame: Baseline and Day 85

    Change in body weight from Baseline to Day 85

  3. 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

  4. Change from baseline in hemoglobin A1c

    Time frame: Baseline and Day 85

    Change in hemoglobin A1c from Baseline to Day 85

  5. 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

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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