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NCT Number: NCT05292911

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

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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

Catalina Research Institute, Montclair, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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:
  • Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
  • 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 one or more TEAEs

Secondary outcomes

  1. Change from baseline in liver fat fraction by MRI-PDFF

    Time frame: Baseline to Day 85

    Change in MRI-PDFF

  2. Change from baseline in body weight

    Time frame: Baseline to Day 85

    Change in body weight

  3. Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)

    Time frame: Baseline to Day 85

    Change in lipid metabolism (TC, HDL, LDL)

  4. Change from baseline in hemoglobin A1c

    Time frame: Baseline to Day 85

    Change in hemoglobin A1c

  5. Change from baseline in fibrosis markers (Pro-C3)

    Time frame: Baseline to Day 85

    Change in fibrosis markers (Pro-C3)

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
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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