Clinical trial NCT05292911: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Obese
Overweight
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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:

  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

Primary outcomes:
measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 110
Secondary outcomes:
measure: Change from baseline in liver fat fraction by MRI-PDFF
timeFrame: Baseline to Day 85
measure: Change from baseline in body weight
timeFrame: Baseline to Day 85
measure: Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
timeFrame: Baseline to Day 85
measure: Change from baseline in hemoglobin A1c
timeFrame: Baseline to Day 85
measure: Change from baseline in fibrosis markers (Pro-C3)
timeFrame: Baseline to Day 85
Other outcomes:
Locations:
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Covenant Research and Clinics
state: Florida
city: Sarasota
country: United States
facility: Headlands Research Sarasota
state: Florida
city: Las Vegas
country: United States
facility: Wake Research CRCN
state: Nevada
city: Austin
country: United States
facility: Accelemed Research Institute
state: Texas
city: Austin
country: United States
facility: Pinnacle Research
state: Texas
city: Brownsville
country: United States
facility: South Texas Research Institute
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Research
state: Texas
city: Salt Lake City
country: United States
facility: Cognitive Clinical Trials
state: Utah
Study officials:
affiliation: Altimmune, Inc.
name: Sarah K Browne, MD
role: STUDY_DIRECTOR
References: