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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05292911
Recruitment Status : Active, not recruiting
First Posted : March 23, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Study Description
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Brief Summary:
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).

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

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 9, 2022
Actual Primary Completion Date : October 4, 2022
Estimated Study Completion Date : November 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 one or more TEAEs


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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:

    1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
    2. 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): NCT05292911


Locations
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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: NCT05292911    
Other Study ID Numbers: ALT-801-106
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022

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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