Clinical trial NCT05006885: ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
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
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: 2021-08-16
Enrollment: 95
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: 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).

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.

Eligibility 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

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 and Day 85
measure: Change from baseline in body weight
timeFrame: Baseline and Day 85
measure: Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
timeFrame: Baseline and Day 85
measure: Change from baseline in hemoglobin A1c
timeFrame: Baseline and Day 85
measure: Change from baseline in fibrosis markers (Pro-C3)
timeFrame: Baseline and Day 85
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Headlands Research Scottsdale
state: Arizona
city: Tucson
country: United States
facility: QLMC
state: Arizona
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: