LivingGLP1
Study S000854

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Registration

Registration
NCT05134662
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
DOUBLE
Status
COMPLETED
Enrollment
55
Start
2022-02-01
Primary completion
2023-02-03
Lead sponsor
Altimmune, Inc.
Conditions
Type 2 Diabetes
Interventions
DRUG:ALT-801; OTHER:Placebo
Results posted
FALSE

Registered primary outcomes

  • The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) [Up to Day 110]
  • Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin [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) [Baseline to Day 85]

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