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

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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).

Key facts

Study ID

NCT05134662

Run by

Altimmune, Inc.

People needed

55

Starts

2022-02-01

Expected to finish

2023-03-09

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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 (BMI >/=28.0 kg/m2)
• Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (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
• Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control

You may not qualify if…

• Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL
• History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues

Where it is running

• 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
• Altimmune CTM — Knoxville, Tennessee, United States
• Altimmune CTM — San Antonio, Texas, United States
• Altimmune CTM — Tomball, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.