search
Back to results

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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALT-801
Placebo
Sponsored by
Altimmune, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Obese, Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catalina Research Institute
  • Clinical Trials Research
  • Panax Clinical Research
  • Covenant Research and Clinics
  • Headlands Research Sarasota
  • Wake Research CRCN
  • Accelemed Research Institute
  • Pinnacle Research
  • South Texas Research Institute
  • South Texas Research Institute
  • Diagnostics Research Group
  • Pinnacle Research
  • Cognitive Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ALT-801 Dose Level 1

ALT-801 Dose Level 2

ALT-801 Dose Level 3

Placebo

Arm Description

Administered once a week for 12 weeks

Administered once a week for 12 weeks

Administered once a week for 12 weeks

Administered once a week for 12 weeks

Outcomes

Primary Outcome Measures

The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Number of participants with one or more TEAEs

Secondary Outcome Measures

Change from baseline in liver fat fraction by MRI-PDFF
Change in MRI-PDFF
Change from baseline in body weight
Change in body weight
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Change in lipid metabolism (TC, HDL, LDL)
Change from baseline in hemoglobin A1c
Change in hemoglobin A1c
Change from baseline in fibrosis markers (Pro-C3)
Change in fibrosis markers (Pro-C3)

Full Information

First Posted
March 15, 2022
Last Updated
July 24, 2023
Sponsor
Altimmune, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05292911
Brief Title
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Obese, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALT-801 Dose Level 1
Arm Type
Experimental
Arm Description
Administered once a week for 12 weeks
Arm Title
ALT-801 Dose Level 2
Arm Type
Experimental
Arm Description
Administered once a week for 12 weeks
Arm Title
ALT-801 Dose Level 3
Arm Type
Experimental
Arm Description
Administered once a week for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered once a week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ALT-801
Other Intervention Name(s)
Pemvidutide
Intervention Description
Injected subcutaneously (SC)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Injected subcutaneously (SC)
Primary Outcome Measure Information:
Title
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Description
Number of participants with one or more TEAEs
Time Frame
Up to Day 110
Secondary Outcome Measure Information:
Title
Change from baseline in liver fat fraction by MRI-PDFF
Description
Change in MRI-PDFF
Time Frame
Baseline to Day 85
Title
Change from baseline in body weight
Description
Change in body weight
Time Frame
Baseline to Day 85
Title
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Description
Change in lipid metabolism (TC, HDL, LDL)
Time Frame
Baseline to Day 85
Title
Change from baseline in hemoglobin A1c
Description
Change in hemoglobin A1c
Time Frame
Baseline to Day 85
Title
Change from baseline in fibrosis markers (Pro-C3)
Description
Change in fibrosis markers (Pro-C3)
Time Frame
Baseline to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K Browne, MD
Organizational Affiliation
Altimmune, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Clinical Trials Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Covenant Research and Clinics
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Headlands Research Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Wake Research CRCN
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Accelemed Research Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Pinnacle Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
South Texas Research Institute
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pinnacle Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cognitive Clinical Trials
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs