This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Altimmune CTM
Fort Myers, Florida, United States
Altimmune CTM
Sarasota, Florida, United States
Altimmune CTM
River Forest, Illinois, United States
Altimmune CTM
Kansas City, Missouri, United States
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 110
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
Time frame: Baseline to Day 85
Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
Time frame: Baseline to Day 85
Change from baseline in fasting serum glucose
Time frame: Baseline to Day 85
Change from baseline in hemoglobin A1c (HbA1c)
Time frame: Baseline to Day 85
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Altimmune CTM
Knoxville, Tennessee, United States
Altimmune CTM
San Antonio, Texas, United States
Altimmune CTM
Tomball, Texas, United States