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

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ClinicalTrials.gov Identifier: NCT05006885
Recruitment Status : Completed
First Posted : August 16, 2021
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Drug: ALT-801 Other: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 30, 2021
Actual Primary Completion Date : August 17, 2022
Actual Study Completion Date : August 17, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALT-801 Dose Level 1
Administered once a week for 12 weeks
 Drug: ALT-801
Injected subcutaneously (SC)
Other Name: Pemvidutide
Experimental: ALT-801 Dose Level 2
Administered once a week for 12 weeks
 Drug: ALT-801
Injected subcutaneously (SC)
Other Name: Pemvidutide
Experimental: ALT-801 Dose Level 3
Administered once a week for 12 weeks
 Drug: ALT-801
Injected subcutaneously (SC)
Other Name: Pemvidutide
Placebo Comparator: Placebo
Administered once a week for 12 weeks
 Other: Placebo
Injected subcutaneously (SC)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05006885


Locations
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United States, Arizona
Headlands Research Scottsdale
Scottsdale, Arizona, United States, 85260
QLMC
Tucson, Arizona, United States, 85712
United States, California
Catalina Research Institute
Montclair, California, United States, 91763
Clinical Trials Research
Sacramento, California, United States, 95648
United States, Florida
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Covenant Research and Clinics
Sarasota, Florida, United States, 34240
Headlands Research Sarasota
Sarasota, Florida, United States, 34243
United States, Nevada
Wake Research CRCN
Las Vegas, Nevada, United States, 89106
United States, Texas
Accelemed Research Institute
Austin, Texas, United States, 78745
Pinnacle Research
Austin, Texas, United States, 78757
South Texas Research Institute
Brownsville, Texas, United States, 78520
South Texas Research Institute
Edinburg, Texas, United States, 78539
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Pinnacle Research
San Antonio, Texas, United States, 78229
United States, Utah
Cognitive Clinical Trials
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Altimmune, Inc.
Investigators
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Study Director: Sarah K Browne, MD Altimmune, Inc.
More Information
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Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT05006885    
Other Study ID Numbers: ALT-801-105
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Altimmune, Inc.:
Obese
Overweight
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Overweight
 Overnutrition
Nutrition Disorders
Body Weight
Digestive System Diseases