ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
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
1 other identifier
interventional
95
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2021
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2022
CompletedJuly 27, 2023
July 1, 2023
11 months
July 30, 2021
July 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Number of participants with 1 or more TEAEs up to Day 110
Up to Day 110
Secondary Outcomes (5)
Change from baseline in liver fat fraction by MRI-PDFF
Baseline and Day 85
Change from baseline in body weight
Baseline and Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Baseline and Day 85
Change from baseline in hemoglobin A1c
Baseline and Day 85
Change from baseline in fibrosis markers (Pro-C3)
Baseline and Day 85
Study Arms (4)
ALT-801 Dose Level 1
EXPERIMENTALAdministered once a week for 12 weeks
ALT-801 Dose Level 2
EXPERIMENTALAdministered once a week for 12 weeks
ALT-801 Dose Level 3
EXPERIMENTALAdministered once a week for 12 weeks
Placebo
PLACEBO COMPARATORAdministered once a week for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altimmune, Inc.lead
Study Sites (15)
Headlands Research Scottsdale
Scottsdale, Arizona, 85260, United States
QLMC
Tucson, Arizona, 85712, United States
Catalina Research Institute
Montclair, California, 91763, United States
Clinical Trials Research
Sacramento, California, 95648, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Covenant Research and Clinics
Sarasota, Florida, 34240, United States
Headlands Research Sarasota
Sarasota, Florida, 34243, United States
Wake Research CRCN
Las Vegas, Nevada, 89106, United States
Accelemed Research Institute
Austin, Texas, 78745, United States
Pinnacle Research
Austin, Texas, 78757, United States
South Texas Research Institute
Brownsville, Texas, 78520, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Pinnacle Research
San Antonio, Texas, 78229, United States
Cognitive Clinical Trials
Salt Lake City, Utah, 84117, United States
Related Publications (1)
Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS. Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jan;82(1):7-17. doi: 10.1016/j.jhep.2024.07.006. Epub 2024 Jul 11.
PMID: 39002641DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah K Browne, MD
Altimmune, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 16, 2021
Study Start
September 30, 2021
Primary Completion
August 17, 2022
Study Completion
August 17, 2022
Last Updated
July 27, 2023
Record last verified: 2023-07