NCT05134662

ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	ALT-801	Injected subcutaneously (SC)
OTHER	Placebo	Injected subcutaneously (SC)

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-03
• Completion: 2023-03-09
• First posted: 2021-11-26
• Last updated: 2025-06-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study